Characteristics of Included Studies

MethodsParticipantsOutcomesInterventionsNotes
ADDOLORATO2004
Study Type: RCT

Blindness: No mention

Duration (days): Mean 180

Notes: Details on randomisation not adequately reported. Allocation concealment not addressed

Info on Screening Process: 112 considered; 66 affected by anxiety & depression - randomized.
n= 66

Age: Mean 31

Sex: 29 males 37 females

Diagnosis: Exclusions:
-

presence of psychiatric disorders other than anxiety or depression

-

endocrine disorders

-

abuse of alcohol and.or other substance addition

-

consumption of psychoactive drugs and/or current psychiatric treatment

-

secondary causes of villous atrophy

Baseline: No signifiant differences at baseline. Baseline scores of Zung not reported.
Data Used
  • Remission (below cut-off)
Notes: TAKEN AT: pre- and post-intervention (6-months post-baseline). DROP OUTS: none reported.
Group 1 N= 33
  • Individual based cognitive and behavioural skills - Modified & adapted to physical health problem. Stress management; cause & effect of problems related to CD; every day difficulties; evaluate/discuss dietary restrictions/Family members at times participated. Individual. 1 session every 2 weeks.
Group 2 N= 33
Do not perform sensitivity analysis as participants recruited for depression. Intervention modified to the physical illness.
Results from this paper:
Quality assessed: +
ANTONI2006
Study Type: RCT

Study Description: *Analysed 101/130: those with an undetectable viral load were excluded (N= 15 - treatment; N=14 - control). Includes LTFU & non-completer

Type of Analysis: *Completers

Blindness: No mention

Duration (days): Mean 70

Followup: 6- and 12-months

Setting: US
Setting not reported

Notes: Randomisation: no. id's were drawn from a box for assignment to conditions by the project manager & overseen by prinicipal investigator.

Info on Screening Process: 257 HIV+ gay men were approached; 81 refused; 46 were excluded. Began trial with 130 men analysed only 101 with a detectable HIV viral load at baseline.
n= 101

Age: Mean 42

Sex: all males

Diagnosis:
  • 100% HIV by Not specified
  • 54% AIDS by Clinical judgement
Exclusions:
-

prescribed medications with immunomodulatory effects (i.e. interferon)

-

history of chemotherapy or whole body radiation treatment for cancer

-

history of chronic illness associated with permanent changes in the immune system

-

antibiotic use for an acute infection with the past 2 weeks

-

changes in the Highly Active Antiretroviral Therapy (HAART)

-

acute bodily infection during the past month

-

hospitalization for surgery within the past 3-months

-

intravenous drug use within the past 6-months

-

cognitive impairment

-

inability to read at the 6th grade level

-

current psychosis, drug or alcohol dependence and panic disorder

-

active suicidality

-

not between the ages of 18 and 65

-

not gay

Notes: Average time since HIV diagnosis = 7.8 years (SD = 5.1); reported on average 6 HIV symptoms (range 0-12)

Baseline: No baseline differences between treatment and control on depressed mood. Baseline scores of depression for treatment group (BDI-21 item) = 11.6 (SD = 8.0) and control group = 12.4 (SD = 9.2).
Data Used
  • POMS-D
  • BDI-21 item
Notes: TAKEN AT: pre-, post-treatment (3-months) & follow-up at 6-, 12-months. DROP OUTS: LTFU - N=22 treatment, N=23 control; Discontinued participantion - N=2 treatment, N=5 control; EXCLUDED: N=15 treatment, N=14 control after randomisation.
Group 1 N= 76
  • Group based cognitive and beahvioural skills - Cognitive behavioral stress management + medication adherence training that focused on adherence & medical side effects. 10 weekly 135 min group sessions (4-9 men). Homework assign. Therapist = postdoctoral fellows/graduate students. Monitored fidelity.
Group 2 N= 54
  • Control - Medication adherence training only = licensed clinical pharmacists 1-H session at baseline, 30 min mantenance sesssions at post-treatment & 6-month follow-up. Gave information on medication, side effects and importance of adherence.
Particpants were not recruited for depression but had a mean BDI in the clinical range at baseline - study will be used in a sensitivity analysis. Intervention for stress management (not specific to depression).
Results from this paper:
Quality assessment = +
BALFOUR2006
Study Type: RCT

Type of Analysis: No mention

Blindness: No mention

Duration (days): Mean 28

Setting: US, Ottawa

Notes: Randomisation by random numbers table.

Info on Screening Process: Details on screening not reported.
n= 63

Age: Mean 40

Range 17-61 Sex:

Diagnosis:
  • HIV/AIDS by Current diagnosis
Exclusions:
-

not diagnosed with HIV for at least 6-months

-

currently on antiretroviral therapy

-

HIV RNA levels less than 50 copies/ml

-

not able to read and write English or French

-

actively suicidal or psychotic

Notes: Mean CD4 cell count of participants = 356 cell/ul; mean HIV plasma viral load approx 73 000 copies/ml.

Baseline: No differences at baseline on outcome measures. 43% of patients had CES-D clinical cut-off score of 16 - results presented for sub-group of patients with depression N= 15 - treatment; N= 12 - control.
Data Used
  • CES-D
Notes: TAKEN AT: pre- and post-intervention. DROP OUTS: none reported.
Group 1 N= 15
  • Psychoeducation plus other - Individual. 4 × weely. 75 min. 1. express feelings of HIV/medication. 2. Education regarding HIV. 3. barriers to medication. 4. roles of stress/stratergies to cope with depressive symptoms. Therapist = psychologist. Manual.
Group 2 N= 12
  • TAU - Standard HIV clinic multidisciplinary team care
Do not need to perform sensitivity as results are reported for a sub-group with depression. Component of intervention aimed at reducing depression.
Results from this paper:
Quality assessed: +
BARTH2005
Study Type: RCT

Study Description: *analyse data for participants who provided outcome data

Type of Analysis: *non-ITT

Blindness: No mention

Duration (days): Range 21-28

Followup: No follow-up

Setting: GERMANY
Inpatient (3 cardiac rehabilitation hospitals)

Notes: Randomised by closed envelopes.

Info on Screening Process: 5898 consecutive admission; 1709 screened; 441 had mental distress (HADS >17); 268 excluded from interview; 107 did not have depressive disorder as assessed in interview, further 7 excluded; 59 randomised; lost to follow-up: 0 - treatment, 4 - control.
n= 59

Age: Mean 58

Sex: 45 males 14 females

Diagnosis: Exclusions:
-

HADS < 17 and no DSM-IV diagnosis of unipolar affective disorder

Notes: Myocardial infarction = 57.6%; coronary artery bypass graft = 33.9%; percutaneous transluminal coronary angioplasty = 22.0%; unstable angina pectoris 5.0%

Baseline: No significant baseline differences between groups on measures of depression. Baseline severity of depression as measured by BDI = 19.04 (6.39) - treatment and 21.25 (5.43) - control and HADS (total) = 23.07 (4.02) - treatment and 24.58 (4.51) - control.
Data Used
  • HADS
  • BDI-21 item
Notes: TAKEN AT: pre-and post-treatment. DROP OUTS: LTFU - 0/27 treatment and 4/32 control.
Group 1 N= 27
  • Individual based cognitive and behavioural skills - 3-, 4-week inpatient rehabilitation. Individual therapy. 4-6 sessions, 50 min each. Delivered by psychotherapist. Education; self-help materials; aimed at reducing depression. Cognitive-behavioural approach.
Group 2 N= 28
  • Control - Treatment as usual = exercise, diet counseling, relaxation and health behaviour education.
Do not need to perform sensitivity analysis as participants recruited for depression; intervention aimed at reducing depression.
Results from this paper:
Quality assessment = +
BRODY2006
Study Type: RCT

Type of Analysis: Completers

Blindness: No mention

Duration (days): Mean 42

Setting: US

Notes: Randomisation: computer-generated.

Info on Screening Process: 349 screened, 252 randomised, 214 completed treatment, 32 depressed at baseline.
n= 32

Age: Mean 82

Sex: 11 males 21 females

Diagnosis: Exclusions:
-

did not meet criteria for DSM-IV major or minor depression

-

GDS-15 < 5

Baseline: Baseline depression GDS-15: 7.50 (2.19), 7.80 (2.35).
Data Used
  • GDS-15 item
Notes: TAKEN AT: baseline and 6-month FU. DROP OUTS:only used completers who had depression at baseline.
Group 1 N= 12
  • Self-help - Cognitive and behavioural. Group therapy. Problem solving, cognitive & behavioural elements, guided practice, designed to meet the needs of sight impaired adults. 12 hours over 6-weeks.
Group 2 N= 20
  • Control - Two arms: audio taped health education & waitlist. 12 hours over 6-weeks.
Subset from larger study with depression at baseline. Intervention modified for chronic physical health problem.
Results from this paper:
Quality assessed: +
BROWN1993
Study Type: RCT

Study Description: *Did not included the 12 subjects who dropped out of treatment before completion of final post-treatment assessment

Type of Analysis: *Completers

Blindness: No mention

Duration (days): Mean 84

Followup: 3-, 9-, & 15-month

Setting: US
Hospital

Notes: Details on randomisation not reported.

Info on Screening Process: 54/107 met all the study criteria: reasons for exclusions included chronic, severe depression and/or anxiety preceeding the cardiac event; 14/54 excluded as dropped out of the study before final post-treatment assessment.
n= 40

Age: Mean 61

Sex: 39 males 11 females

Diagnosis: Exclusions:
-

did not have a myocardial infarction and/or bpass surgery in the last 4-24 months (according to physican's reports)

-

prognosis worse than 3.3 based on the New York Heart Association

-

unstable cardiac status with medical contraindictations to increased physical activitity according to physicians reports

-

did not have an onset of depression and/or anxiety associated with the MI or bypass surgery based on the Schedule of Affective Disorders and Schizophrenia (SADS)

-

scores less than 13 on the BDI; or less than 70 on the global severity index on the SCL 90-R

-

spouses, friends or relatives who are not willing to participate in the treatment

-

not between 43 and 75 years old

Notes: 12 had MI only; 15 bypass only; 13 MI and bypass.

Baseline: Control group was significantly higher on BDI (17.25 vs 12.06) and the GSI (71.21 vs 65.15).
Data Used
  • SCL 90
  • BDI-21 item
Notes: TAKEN AT: pre- & post-treatment; 3-, 9- & 15-months follow-up. DROP OUTS: 12/54; in addition, when some participants dailed to complete some assessments, their scores were removed from those analyses.
Group 1 N= 20
  • Individual based cognitive and behavioural skills - 12 weekly × 1H sessions. Delivered by clinical psychogist/psychiatrist. Included pleasant activities, relaxation, cognitive restructuring, anger management. Therapist, patient + partner. Intervention for depression.
Group 2 N= 20
  • Counseling - Therapists activities included expression of support, warmth & empathy. Offered interpretation, reflections & clarifications of the participants' feelings. Based on Rogers.
Do not perform a sensitivity analysis - participants recruited for onset of depression associated with physical health problem; intervention for depression.
Results from this paper:
Quality assessment: +
CHESNEY2003
Study Type: RCT

Study Description: *Only includes participants with outcome data

Type of Analysis: Completers*

Blindness:

Duration (days): Mean 70

Followup: 6-, 12-months (not for WLC)

Setting: US, San Francisco
Not specified

Notes: Details on randomisation not reported. Allocation concealment not addressed.

Info on Screening Process: 165 met entry criteria, 149 enetered the study: 54 group based cognitive-behavioural, 51 health education, 44 control. Post-treatment: 128/149 (86%) retained.
n= 149

Age: Mean 39 Range 24-58

Sex: all males
  • Diagnosis:100% HIV/AIDS by Self-report
  • 100% Depression by CES-D
Exclusions:
-

not self-identified as gay or bisexual

-

not between the ages of 21 and 60

-

self-reported CD4 levels not between 200 and 700 cells/mm3

-

score less than 10 on the CES-D

-

major depressive disorder & psychotic disorders

-

history of alcohol dependence or substance use disorder in the past year

-

currently in psychotherapy or were using therapeutic doses of psychoactive medication on a regular basis

-

CD4 T-cell count to confirm diagnosis of AIDS

Notes: Mean CD4 count was 403 (SD = 109); 7% had an AIDS-defining condition. Information on time since diagnosis not specified.

Baseline: No significant differences at baseline. Baseline scores of CES-D: 17.9 (SD = 9.6) - group based cognitive-behavioural intervention; 15.7 (SD = 9.5) - health education; 16.9 (SD = 9.2) control.
Data Used
  • CES-D
Notes: TAKEN AT: pre- and post-intervention (not including booster sessions) + 6-, 12-month FU (for two treatment conditions only). DROP OUTS: 21/149 (14%) at 3-month FU.
Group 1 N= 54
  • Group based cognitive and beahvioural skills - Group based (6-8). Cognitive theory aimed at stress & coping. Homework assigned. 10 weekly 90 min sessions + 6 maintenance sessions for remainder of year. Adaptation for HIV-related stressors. Co-therapists = graduate social worker/clinical psychology
Group 2 N= 51
  • Health-education - 10 weekly group 90 min sessions on HIV-related topics & resources. Including information on clinical trials, legal issues. 6 maintenance sessions for remainder of year.
Group 3 N= 44
  • Control - Waitlist control. After post-intervention and whilst other treatment conditions were receiving booster sessions during follow-up, received group based cognitive-behavioural intervention.
Do not perform sensitivity analysis as participants recruited for depression and chronic physical health problems. Sub-group analysis: group based cognitive-behavioural intervention aimed at psychosocial stresses.
Results from this paper:
Quality assessed: +
CLARK2003
Study Type: RCT

Type of Analysis: Completers

Blindness: No mention

Duration (days): Mean 150

Setting: Australia, Adelaide
Community

Notes: Randomisation = computer-gernated. Allocation by sealed envelopes.

Info on Screening Process: 139 admissions to rehabilitation unit, 32 excluded, 107 registed, 68 randomised: 33 -treatment, 35 - control. 62 completed: 30 - treatment, 32 - control.
n= 62

Age: Mean 72

Sex: 38 males 24 females

Diagnosis:
  • 100% Stroke by Current diagnosis
Exclusions:
-

no confirmed diagnosis of stroke

-

not discharged at home

-

discharged to in-home rehabilitation or residential care

-

not co-resident with spouse

-

severe expressive or receptive language problems

-

poor command of English

-

cognitive deficiency (Mini Mental State Examination)

Baseline: Did not test for differences at baseline for outcome measures. **Baseline GDS-15 score: 3.7 (SD = 2.7) - treatment, 4.0 (SD = 2.8) - control JUST BELOW CUT-OFF SCORE OF 5**
Data Used
  • GDS-15 item
  • SF-36
Notes: TAKEN AT: pre - and post-intervention. DROP OUTS: 3/33 (9%) - treatment & 3/35 (8%) - control.
Group 1 N= 30
  • Psychoeducation plus other - Individual. Information package on stroke, practical coping suggestions, resources in community & support structures. Therapist = social worker. Counselling for patient + spouse for stroke related stresses. 3 × 1H sessions at home over 5 months.
Group 2 N= 32
  • No treatment - No mention on the control group other than they did not receive the intervention. All participants discharged into community - assume it is a no treatment control.
Perform sensitivity analysis as participants are not recruited for depression (and are sub-threshold). Intervention has a componenet that = psychosical as discuss stresses related to physical health problem.
Results from this paper:
Quality assessed: +
COURNEYA2007
Study Type: RCT

Study Description: *FU data for those who completed measures

Type of Analysis: Completers*

Blindness: No mention

Duration (days): Mean 119

Setting: Canada

Notes: Randomisation using a computer generated program. Allocation concealment adequate.

Info on Screening Process: 1226/1468 excluded as did not meet eligibility criteria, 242 randomised
n= 242

Age: Mean 50 Range 25-78

Sex: all females

Diagnosis: Exclusions:
-

not able to speak English or French

-

pregnant

-

<18

-

not first line adjuvant chemotherapy

-

incomplete axillary surgery

-

transabdominal rectus abdominus muscle reconstructive surgery

-

uncontrolled hypertension

-

cardiac illness

-

psychiatric illness

Notes: Breast cancer I to IIIA

Baseline: No significant differences at baseline. Depression at baseline CES-D: resistance training 13.8 (10.1), aerobic training 12.8 (9.8), TAU 13.9 (9.7).
Data Used
  • CES-D
Notes: TAKEN AT: baseline, mid-point, post-intervention, 6-month FU. DROP OUT: 10/160 exercise; 7/82 waitlist
Group 1 N= 150 Group 2 N= 75
  • Waitlist - Asked to not participate in any exercise program - were offered 1-month exercise program post-intervention.
Participants not recruited for depression - just below cutoff on depression scale.
Results from this paper:
Quality assessed: +
DAVIS1984
Study Type: RCT

Type of Analysis: Completers

Blindness: No mention

Duration (days): Mean 42

Followup: 6-weeks

Notes: Details on randomisation not reported.

Info on Screening Process: All participants were appropriate for the study; 4 declined. 2 participants in Waitlist dropped out.
n= 13

Age: Mean 33

Sex: 3 males 10 females

Diagnosis: Exclusions:
-

IQ < 70

-

behaviour problems

-

did not have depression

Notes: All subjects epileptic and receiving anticonvulsant mediction. Mean length of seizure disorder was 13.69 years (SD = 11.1)

Baseline: No significance test conducted. Baseline scores of BDI: 20.75 - treatment; 20.75 - control (SDs not reported; small ns in each group).
Data Used
  • BDI
Notes: TAKEN AT; pre- and post treatment. DROP OUTS: 0/9 CBT, 2/7 WLC. *NO STANDARD DEVIATIONS REPORTED.
Group 1 N= 8
  • CBT - 6 weeky 2 hour classes. Group therapy. Led by social workers. Homework assigned. Therapy designed to treat depression. Pleasurable. activities, physical exercise, self-talk, thought stopping, increasing postive cognitions. FU class
Group 2 N= 5
  • Waitlist - Offered treatment after post-assessment.
Participants recruited for depression and chronic physical health problems; intervention designed to treat depression.
3 in the treatment, 1 in the control group were receiving psychotropic medication.
Results from this paper:
Quality assessed: +
DESROSIERS2007
Study Type: RCT

Study Description: Single blind = rater only blinded

Type of Analysis: Completer

Blindness: Single blind

Duration (days):

Setting: CANADA
Community

Notes: Randomisation by computer-generated with stratification based on functional independence.

Info on Screening Process: 230 eligible, 168 excluded, 62 randomised, 56 analysed.
n= 62

Age: Mean 71

Sex:

Diagnosis:
  • 100% Stroke by Current diagnosis
Exclusions:
-

clinical diagnosis of stroke

-

not living in the community

-

no self-report problems with leisure activities

-

cognitive problenm score < or equal to the 5th percentile on the Modified Mini-Mental State

-

language comphrehension problems

-

severe comorbidities

Baseline: Differences at baseline on the HRQOL which was lower in the control group. Baseline scores of depression on CES-D:18.5 (SD = 12.1) - treatment & 16.3 (SD = 9.0) - control.
Data Used
  • HRQOL
  • CES-D
Notes: TAKEN AT: pre- and post-intervention. DROP OUTS; 4/33 - treatment, 2/29 - control.
Group 1 N= 33
  • Social support - Leisure education program: aim to optimize leisure experiences. 8-12 sessions × 1H. Focused on leisure awareness, self-awareness & competency deveopment. Therapist = occipational/recreational. Delivered home/community.
Group 2 N= 29
Perform sensitivity analysis as participants not recruited for depression. Need to perform change score for HRQOL as there are differences as baseline.
Results from this paper:
Quality assessed; +
EVANS1995
Study Type: RCT

Study Description: *Included only those for whom all data were colllected includign FU data.

Type of Analysis: *Completers

Blindness: No mention

Duration (days): Mean 56

Followup: 6-month

Setting: USA
Outpatient

Info on Screening Process: 95 patients scheduled for radiation treatment; 78 had a CES-D of 16+ and were randomized.
n= 78

Age: Mean 54

Sex: 47 males 31 females

Diagnosis: Exclusions:
-

CES-D less than 16

Notes: Stage II cancer: N=30 lung cancer, N=22 bladder, N=16 postate, N=4 head-neck. Scheduled for radiation treatment. Mean duration of knowledge on their diagnosis = 12.3 weeks.

Baseline: Did not test for differences in severity of depression at baseline. Baseline scores of depression = 27.2 (SD = 8.8) - cognitive & behavioural; 27.9 (SD = 8.4) - peer support; 29.0 (SD = 7.0) - control
Data Used
  • CES-D
Notes: TAKEN AT: post-treatment and 6-month follow-up. DROP OUTS: 6 lost to FU because of death/illness;
Group 1 N= 27 Group 2 N= 21
  • Peer Support - 8-week, group therapy 1 hour per week, 6-9 patients led by social worker. Modeled after support groups typically used in chronic illness. Members encouraged to describe feelings about having cancer.
Group 3 N= 24
  • No treatment - Did not attend intervention Offered crisis intervention + individual therapy at no charge oustide study protocol (only 2 persons took up offer).
Participants recruited for depression and chronic physical health problems; intervention for depression.
Results from this paper:
Quality assessed: +
FOLEY1987
Study Type: RCT

Type of Analysis: *Completers

Blindness: No mention

Duration (days): Mean 35

Setting: GERMANY
Outpatient

Notes: Details on randomisation not reported. Allocation concealment not addressed.

Info on Screening Process: 41 met criteria; *36 provided pre-and post-assessments and analyzed.
n= 36

Age: Mean 39

Sex: 5 males 31 females

Diagnosis: Exclusions:
-

no confirmed MS diagnosis

-

a level of disability greater than 8 o the 10-point disability status scale

-

major cognitive deficitis

Baseline: No significant baseline differences between groups. Baseline scores of BDI depression: 24.4 (SD = 13.0) - treatment & 21.7 (15.0) - control.
Data Used
  • BDI

Data Not Used
  • Physical health outcomes - no data
Notes: TAKEN AT: pre- and post-intervention. DROP OUTS: 5/4.
Group 1 N= 18
  • Individual based cognitive and behavioural skills - 6 session cognitive-behavioural + shortened progressive deep-muscle relaxation. Therapist = advanced clinical psychologist. Focused on psychosocial stressors.
Group 2 N= 18
  • Control - Waitlist control, received treatment after 5 week delay. In the mean time received TAU: all received minimum of 2H supportive psychotherapy. N=2 antidepressants, 2 family counseling, 3 individual counseling.
Perform sensitivity analysis as participants not recruited for depression & chronic physical illness. Sub-group analysis: interventon for psychosocial stressors.
Results from this paper:
Quality assessed: +
HECKMAN2007
Study Type: RCT

Study Description: * Perform analysis on participants who completed assessment form.

Type of Analysis: *Completers

Blindness: No mention

Duration (days): Mean 56

Followup: 4-, 8-month

Setting: US

Notes: Details on randomisation/allocation concealment not reported.

Info on Screening Process: 360 eligible; 61 excluded; 299 randomized; 257 completed post-assessment; 243 completed 4-month FU; 223 completed 8-month FU
n= 299

Age: Mean 43

Sex: 210 males 89 females

Diagnosis:
  • 100% HIV/AIDS by Self-report
Exclusions:
-

18 years +

-

informed consent

-

self-reported diagnosis of HIV/AIDS

-

residence in community of 50 000 or fewer & at least 20 miles from a city of 100 000 or more

Notes: Participants reported having lived with HIV for a mean of 10 years.

Baseline: No differences between group at baseline on main outcome measures. Baseline depression scores for all paritcipants = BDI 22.1 (SD = 10.5) with 71% reporting a score of 16+. Usual care: 22.47 (1.03); psycho-educ : 21.33 (1.16); cognitive-behavioural: 22.55 (1.02).
Data Used
  • HIV-Related Life-Stressor Burden Scale
  • SCL 90
  • BDI-21 item
Notes: TAKEN AT: pre- and post-assessment & 4-. 8-month follow-up. DROP OUTS: Completed post-assessment 94/07 (usual care), 66/84 (psycho-education), 97/108 (cognitive-behavioural)
Group 1 N= 107
  • TAU - AIDS service organisations - case management, support groups, social services assistance.
Group 2 N= 108
  • Group based cognitive and beahvioural skills - Coping Improvement Group Intervention - 8 weekly sessions. 6-8 per group. Therapist = Masters/PhD level clinicians. 90 mins. Separate groups for gay men. Cognitive-behavioural principles. Conducted using teleconference. Intervention aimed at stress/coping
Group 3 N= 84
  • Health-education - Information support group intervention - group therapy. Therapist = nurse practitioners/social workers. Separate groups for gay men. 90 min: 60 min assigned to information relating to AIDS/HIV; 30-min topics generated by group.
Perform sensitivity analysis as participants were not recruited for depression and chronic physical health problems. Sub-group analysis as intervention aimed at psychosocial stressors (stress and coping)
Results from this paper:
Quality assessed: +
HENRY1997
Study Type: RCT

Study Description: *'ITT analysis does not included the two participants who discontinues their involvement in the programme for medical reasons.

Type of Analysis: Completers

Blindness: No mention

Duration (days): Mean 42

Followup: No follow-up

Setting: AUSTRALIA, Sydney
Primary care

Notes: Details on randomisation not reported.

Info on Screening Process: 32 potential subjects, 21 met screening criteria, 2 discontinued treatment.
n= 19

Age: Mean 60 Range 47-74

Sex: 9 males 10 females

Diagnosis: Exclusions:
-

no diagnosis of non-insulin-dependent diabetic patients with a duration of > 6-months

-

requiring insulin therapy in the last 6-months

-

currently requiring insulin therapy

-

presence of severe levels of psychopatholoy or major forms of psychiatric disoder such as schizophrenia, bipolar or addictice disorders

-

no bio-chemical evcidence of elevated HbA1 (i.e. <10%) within the past month

Notes: Mean duration of diabetes was 6.4 years (range 1.5 to 23)

Baseline: There were no significant differences between groups at baseline. Baseline scores of BDI depression: 11.10 (SD = 2.69) - treatment; 13.33 (SD = 4.69) - control
Data Used
  • BDI
Notes: TAKEN AT: pre- and post-assessment. DROP OUTS: two participants discontinued their involvement in the programme for medical reasons
Group 1 N= 10
  • CBT - 6 weekly 1.5-hour sessions. Group therapy. Muscle relaxation + cogntive coping skills training (i.e. monitor negative self-statements, problem solving). Homework assignments. Designed to cope with stress & anxiety.
Group 2 N= 9
  • Waitlist - Participants received treatment immediately following the past-treatment assessment period.
Perform sensitivity analysis - participants were not recruited for depression and chronic physical health problems. Intervention designed to reduce stress (and axiety).
Results from this paper:
Quality assessed: +
KELLY1993
Study Type: RCT

Type of Analysis: Completers

Blindness: No mention

Duration (days): Mean 56

Followup: 3-month

Setting: Milwaukee

Notes: Details on randomisation not reported.

Info on Screening Process: 115 completed pre-intervention assessment and had CES-D >16.Only participants for whom all data were collected, including long-term follow-up were included in the analysis.
n= 68

Age: Mean 34

Sex: all males

Diagnosis: Exclusions:
-

a CES-D score < 16

-

female

Notes: N=56 were asymptomatic or had symptoms of immune compromise; N= 12 had illnesses that met Centres fo Disease Control criteria for AIDS. Mean duration of knowledge of symptoms = 31 months

Baseline: No significance test conducted. Baseline scores of CES-D: 27.4 (SD = 8.9) - cognitive and behavioural; 28.1 (SD = 8.5) - peer support; 31.0 (SD = 6.6) - control
Data Used
  • CES-D
Notes: TAKEN AT: pre- and post-intervention an 3-month follow-up. DROP OUTS: only report outcomes for completers.
Group 1 N= 27
  • CBT - 8 week group therapy (8-9 participants). 90 minutes. Led by psychologists, counselors or psychiatry residents. Also discussed safer sex practice. Aimed to reduce anxiety & depression.
Group 2 N= 14
  • Peer Support - 8 week group therapy (8-10 participants). 90 minutes. Led by psychologists, counselors or psychiatry residents. Encouraged members to describe their feelings about having HIV.
Group 3 N= 27
Particpants recruited for depression; cognitive-behavioural interention designed to reduce depression - discussed safe sex practice.
Results from this paper:
Quality assessed: +
KISSANE2007
Study Type: RCT

Type of Analysis: *Completers

Blindness: Open

Duration (days): Mean 37 Range 1-226

Setting: AUSTRALIA, Melbourne (multisite)

Notes: Randomisation: independent using an 'adaptive biased coin design'. Allocation concealment not addressed.

Info on Screening Process: 485 referred; 258 not assessed or randomised; 227 randomised: 147 intervention, 80 control; *117/147, 60/80 analyzed for psychosocial outcomes.
n= 227

Age: Mean 52 Range 25-69

Sex: all females

Diagnosis:
  • Cancer by Histologically confirmed
Exclusions:
-

did not have stage IV breast cancer

-

not geographically accessible

-

had a life expectancy of less than 1 year

-

over 70 years

-

history of other cancers (exept basal cell carcinoma)

-

inadequate English

-

intellectual disability of dementia

Notes: Stage IV Breast cancer

Baseline: No baseline differences between groups for percentage with depression. 34/147 (23%) - treatment and 20/80 (25%) - control had a diagnosis of depression; metaanalysis refers only to this sub-population.
Data Used
  • Remission (no longer meeting diagnosis)
Notes: TAKEN AT: baseline, 6-, 12-, 18-, 24-months. DROP OUTS:
Group 1 N= 147
  • Group existential therapy - Group therapy (12). Weekly 90 min, advised for 1 year. Aim: improve interpersonal relatonships; create network of social support; coping skills. Provides safe form to express feelings/confront existential issues. Co-therapist = psychology/social worker.
Group 2 N= 80
  • Control - ×3 relaxation classes, 1H over 3-week period. Progressive muscular relaxation, guided imagery, manualized method. Encouraged to practice. Also delivered to treatment group. Delivered by occupational therapist.
Participants not recruited for depression and chronic physical health problems; analysis reported for subgroup with depression.
Results from this paper:
Quality assessed: +
KOUKOUVOU2004
Study Type: RCT

Type of Analysis: Completers

Blindness: No mention

Duration (days): Mean 180

Setting: GREECE, Thessalonki

Notes: Details on randomisation not reported. Allocation concealment not addressed.

Info on Screening Process: Details not reported.
n= 29

Age: Mean 53 Range 36-66

Sex: all males

Diagnosis:
  • 100% Cardiovascular disease by Clinical judgement
Exclusions:
-

did not have a diagnosis of CHF mainly based on clinical signs, radiological findings, schocadiographically determined ejection fraction/shortening fraction

-

myocardial infarction/unstable angina, aortic stenosis, diabetes mellitus, uncontrolled hypertension, musculoskeletal limirationsor other contraindications for participating in an exercise program

-

not clinically stable for <3-months

-

not on stable medication or diet

Baseline: No differences at baseline. Baseline scores of depression: HADS-D = 13.1 (SD = 3.13) - treatment, 11.6 (SD = 2.3) - control; BDI = 18.6 (SD = 4.65) - treatment, 18.5 (SD = 5.1) - control. Only 1 patients was found without depression, 7 mild (scores 10-15), 14 moderate (16-23) & 4 severe (>23).
Data Used
  • Physical health outcomes
  • Minnesota Living with Heart failre Questionnaire
  • Quality of Life Index
  • HADS
  • BDI-21 item
Notes: TAKEN: pre- and post-intervention. DROP OUTS: 2/18 - treatment, 1/11 - control.
Group 1 N= 11
  • Control - No further information.
Group 2 N= 18
  • Exercise - 6-months supervised exercise. 2-4 weeks institution-based training. 3-months aerobic training then added resistance exercises. Exercised 50-70% of peak VO2 for 60min (+5min per month) × 3-4 weekly.Progression of exercise duration, freq, intensity.
Perform sensitivity analysis as participants not recruited for depression and chronic physical health problems (only 1 patient w/o depression). Aim of the study is to reduce psychological profile.
Results from this paper:
Quality assessed: +
KUNIK2008
Study Type: RCT

Study Description: *Completed assessments

Type of Analysis: Completers*

Blindness: Single blind

Duration (days): Mean 56

Followup: 12-month

Setting: US

Notes: Randomisation numbers generated by statistician. Allocation concealment not addressed.

Info on Screening Process: 1981 screened, 1351 eligible for pre-treatment testing, 747 presented for testing, 256 eligible, 238 randomised.
n= 238

Age: Mean 66

Sex: 226 males 9 females

Diagnosis: Exclusions:
-

no diagnosis of COPD

-

without moderate anxiety (>16 BAI) and/ or depression BDI > 14)

-

no treatment by GP

-

cognitive disorder (<23 MMSE)

-

psychotic disorder

-

substance abuse/dependence (SCID)

Notes: 32.9% had a history of psychiatric treatment.

Baseline: No significant baseline differences. Depression at baseline (BDI): cognitive and behavioural - 23.44 (12.49); health education - 21.12 (12.09).
Data Used
  • BDI-II
  • SF-36
Notes: TAKEN AT: baseline, mid-point, post-intervention, 4-, 8-, 12-month FU. DROP OUTS (at 12-month FU): 37/89 (CBT); 36/92 (Health education).
Group 1 N= 63
  • Group based cognitive and beahvioural skills - 8 1-H sessions for both anxiety & depression. Group (N=10). Therapist = psych interns, post-doctoral fellows. Discussed symptoms, practice exercises. Relaxation training, pleasurable activity, cognitive therapy, problem-solving.
Group 2 N= 60
  • Health-education - 8 sessions COPD education. 45 lectures/15 discussion. Same therapists. Discussed breathing strategies, medication use, end of life planning.
Recruited for depression.
Results from this paper:
Quality assessed: +
LAI2006
Study Type: RCT

Study Description: Single blind = observer blinded

Blindness: Single blind

Duration (days): Mean 84

Followup: 6-month

Setting: US, Kansas
Home

Notes: Randomisation by random-number generator. Allocation concealment with sealed envelopes.

Info on Screening Process: 582 in registry, 117 consented & eligible, 100 passed cardiac stress test & enrolled, 100 randomised.
n= 100

Age: Mean 70

Sex: 62 males 38 females

Diagnosis:
  • 100% Stroke by Clinical judgement
Exclusions:
-

no diagnosis of stroke according to WHO

-

no confirmed diagnosis of clinical assessment and/or positive CT/MRIscan

-

< 50 years

-

stroke onsent not within 3 - 28 days

-

not a resident within a 50 mile radius

-

subarachnoid hemorrhage

-

lethargic, obtunded, comatose

-

uncontrolled blood pressure

-

hepatic or renal failureNYHA III/IV heart failure

-

known limited life expectancy prestroke disability in self-care lived in nursing home prior to stroke

Baseline: No significant differences between groups at baseline. Baseline GDS score = 3.4 (SD = 2.8) - treatment & 3.8 (SD = 2.7) - control.
Data Used
  • SF-36
  • GDS-15 item
Data Not Used
  • Physical health outcomes - no data

Notes: TAKEN AT: pre- and post-intervention & 6 months FU. DROP OUTS: at FU 10/50 - treatment & 10/50 - control.
Group 1 N= 50
  • Exercise - Delivered at home.3 × week, 36 sessions, 12-weeks. Supervised by a physical/occupational therapist. Equipment supplied i.e. stationary bike, elastic bands.
Group 2 N= 50
  • TAU - Health rehabilitation services as ordered by their physicans. Visted by RA every 2 weeks to provide education about stroke prevention.
Perform sensitivity analysis as participants are not recruited for depression **sub-threshold depression**. Aim of intervention is to reduce depression.
Results from this paper:
Quality assessed: +
LANDREVILLE1997
Study Type: RCT

Study Description: *study used on data from 23 participants who completed study

Type of Analysis: *Completers

Blindness: Open

Duration (days): Mean 28

Setting: CANADA
Setting not specified

Notes: Details on randomisation not reported. Allocation concealment not addressed.

Info on Screening Process: 163 interested in participating; 119 excluded; 44 admitted; N=4 (9%) did not complete study
n= 23

Age: Mean 72

Sex: 3 males 20 females

Diagnosis:
  • 100% Depression by DSM-III-R
  • 100% Functional impariment (elderly) by Functional Autonomy Measurement System
Exclusions:
-

less than 55 years

-

less than 11 on GDS

-

have less than 1 disability in activities of daily living, instrumental activities of daily living or mobility

-

not living in the community in independent living

-

psychosis, alcoholism, immediate suicide risk

-

having an illness known to cause depressive symptoms (yperthroidism)

-

cognitive impairment (>24 on Mini-Mental State Examination)

-

currently on medication for depression or not on stabilized medication for a minimum of 3-months

Notes: Duration of disability (months): 108.70 - treatment; 147.69 - control.

Baseline: Total - major depression = 17; minor depression = 6. Baseline BDI score: 19.70 (6.11) - treatment; 21.76 (12.49)- control. Baseline GDS score: 20.40 - treatment; 18.84 - control.
Data Used
  • Functional Autonomy Measurement System
  • GDS
  • BDI-21 item
Notes: TAKEN AT: pre- and post-treatment and month follow-up for treatment group only. DROP OUTS: 4 (9%) dropped out.
Group 1 N= 10
  • Self-help - Bibliotherapy based on Feeling Good - cognitive therapy for depression. Monitor depressive symptoms. Contacted by telephone once a week to ask about progress & answer questions.
Group 2 N= 13
  • Waitlist - Contacted by therapist via telephone once a week to monitor condition & to encourage group to perservere until treatment became available. Did not offer counselling, telephone lasted 15 mins.
Do not need to perform sensitivity analysis as participants were recruited for depression
Results from this paper:
Quality assessed: +
LARCOMBE1984
Study Type: RCT

Blindness: No mention

Duration (days): Mean 42

Followup: 1-month (treatment group only)

Setting: Not specified

Notes: Details on randomisation not reported.

Info on Screening Process: 54 individuals posted questionnaire, 21 respondents met all criteria in the 1st stage of screening, 1 failed criteria in 2nd stage, 1 discontined treatment after first session.
n= 19

Age: Mean 42 Range 26-61

Sex: 6 males 13 females

Diagnosis: Exclusions:
-

not aged between 20 and 65

-

no self-reported duration of depression of at least 3-months

-

concurrent or prior treatment with major tranquillisers or lithium

-

score of < 20 on BDI

-

does not fulfill research criteria for definite or probablle depression according to the Feighner et al (1972) criteria

-

presence of other major psychological disorders

-

high suicidial risk

-

score outside normal range on the Wechsler MemoryScale and Simpson Memory Pictures Test

-

no diagnosis of MS by neurologist

-

no willingness to participate in a treatment research project

Notes: MS diagnosed 8 participants for 10 years or less; 11 between 11 and 30 years.

Baseline: There were no significant differences between groups at baseline. Baseline BDI scores: 27.44 (SD = 5.64) - treatment; 29.00 (SD = 8.67). Baseline Ham-D scores: 16.22 (SD = 512); 16.90 (SD = 6.41).
Data Used
  • HDRS
  • BDI
Notes: TAKEN AT: pre- and post-intervention an 1-month follow-up (for treatment group only). DROP OUTS: none reported
Group 1 N= 9
  • CBT - Weekly, 90 minute sessions. Group therapy (4-5 participants). Led by graduate students. Pleasant activity schedule; identifying depressive thoughts & distorted cognitions.
Group 2 N= 10
Participants recruited for depression and chronic physical health problems; intervention aimed at depression.
1 participant in the treatment and 2 in the waiting list group were receiving antidepressant medication.
Results from this paper:
Quality assessed: = +
LESPERANCE2007
Study Type: RCT

Type of Analysis: ITT

Blindness: Double blind

Duration (days): Mean 84

Setting: CANADA 9 academic centres
Outpatient

Notes: RANDOMISATION: computer generated and concealed in opaque envelopes

Info on Screening Process: 370 screened, 30 did not have depression, 30 HAMD <20, 6 psychiatric reasons, 6 medical reasons, 5 logistics, 9 refused
n= 284

Age: Mean 58

Sex: 214 males 70 females

Diagnosis:
  • 100% Depression by DSM-IV
  • 100% Cardiovascular disease by Histologically confirmed
Exclusions:
-

<18 years of age

-

HAMD <20

-

depression due to general medical condition

-

psychosis, bipolar,

-

substance abuse

-

suicide risk

-

current use of antidepressants, lithium, anticonvulsants for mood disoder

-

current psychotherapy

-

previous absence of response to citalipram or IPT

-

2 or more previous unsuccessful treatment fo the index depression

-

lifetime history of early termination of citalopram or 2 other SSRIs because of adverse events

-

MMSE < 24

-

clinician judgement that the patient would not adhere to study regime

-

coronary bypass graft surgery planned during the next 4 months

-

Canadian Cardiovascular Society Angine Class of 4

-

unable to speak French/English

Notes: severe depression according to APA criteria

Baseline: Total: HAM-D: 29.68 BDI = 30.3; HAM-D: 30.0 - IPT (+ Placebo), 30.3 - control; BDI = 29.1 - IPT (+ Placebo), 31.3 - control.
Data Used
  • Cardiovascular outcomes
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
  • BDI-II
  • HDRS-24
Notes: Dropouts: IPT + Citalopram 2/67 IPT + Placebo 6/75 Citalopram 3/75 Placebo 6/67
Group 1 N= 75
  • Citalopram - 10mg/d week1, 20mg/d, if HAMD >8 increased to max 40mg/d.
  • Clinical management - information about depression and medication use, encourage adherence, evaluate adverse events. Individual. 20-25 mins. Up to 4 could be done via telephone.
Group 2 N= 67
  • Placebo
  • Clinical management - information about depression and medication use, encourage adherence, evaluate adverse events. Individual. 20-25 mins. Up to 4 could be done via telephone.
Group 3 N= 75
  • IPT - Individual IPT, 12 weekly sessions+placebo: up to 4 sessions via telephone. Focused on dealing with interpersonal conflicts, life transitions, grief, and loss. Conducted by Doctoral or Masters level therapists with mean 15 years experience.
  • Clinical management - information about depression and medication use, encourage adherence, evaluate adverse events. Individual. 20-25 mins. Up to 4 could be done via telephone.
Group 4 N= 67
  • Citalopram + IPT - citalopram and IPT provided as described
  • Clinical management - information about depression and medication use, encourage adherence, evaluate adverse events. Individual. 20-25 mins. Up to 4 could be done via telephone.
Sponsored by Canadian Institutes of Health Research Participants recruited for major depression; intervention modifed for illness
Results from this paper:
Quality assessment score = +
LII2007
Study Type: RCT

Study Description: *Patients in the treatment arm who missed group therapy ×2 were dropped from the study

Type of Analysis: *Completers

Blindness:

Duration (days): Mean 56

Followup: None

Setting: TAIWAN

Notes: Randomisation done by independent researcher using random computer-generated list.

Info on Screening Process: 60 patients recruited from haemodialysis unit; 12 dropped out (10 - treatment, 2 - control)
n= 48

Age:

Sex: 23 males 25 females

Diagnosis: Exclusions:
-

less than 18 years

-

not literate in Mandarin or Taiwanese

-

not diagnosed with End Stage Renal Disease

-

not receiving routine haemodialysis treatment

-

history of psychiatric disorder or severe systemic diseases (i.e. migrating cancer, rheumatoid arthritis, severe congestive heart failre

Notes: End Stage Renal Disease (all on dialysis). Study is looking at the effect of reducing haemodialysis patients' depression; exlcuded participants with history of depression

Baseline: There was no significant difference between groups at baseline on depression scores. Baseline scores of BDI-21 depression scores are: 15.9 (SD = 9.89) - treatment, 12.18 (12.18 (SD = 8.92) - control.
Data Used
  • SF-36
  • BDI-21 item
Notes: TAKEN AT: pre- and post-intervention (1-month after intervention). DROP OUTS: 10/30 - treatment and 2/30 - control
Group 1 N= 20
  • Group based cognitive and beahvioural skills - Cognitive therapy to identify, problem solve irrational thoughts; relaxation skills; health education. Self-efficacy. Coping strategies for depression Group. 2H per week for 8 weeks. 10-15 per group. Therapist = clinical nurse specialist/renal nurse.
Group 2 N= 28
  • TAU - Routine nursing care and a self-care bookley normally provided by the unit.
Perform sensitivity analysis - participants not recruited for depression; intervention for stress/depression - modified and included health education (sub-group analysis).
LUSTMAN1998
Study Type: RCT

Study Description: *ITT did not include 1 participant who did not begin intervention in treatment group
Single blind = rater only

Type of Analysis: *ITT

Blindness: Single blind

Duration (days): Mean 70

Followup: 6-months**

Notes: Randomised via computer algorithm; concealed in sealed envelopes

Info on Screening Process: 135 eligible; 84 excluded; 51 randomised; treatment: 1, control: 0 didn't begin; treatment: 4, control: 4 didn't complete intervention; treatment: 20, control: 22 completed intervention + post-assessment; treatment: 20, control: 21 completed FU
n= 51

Age: Mean 55

Sex: 26 males 25 females

Diagnosis: Exclusions:
-

did not have type II diabetes mellititus

-

not between 21 and 70 years old

-

did not have major depression (according to Diagnositic Interview Schedule)

-

did not score at least 14 on BDI

-

active suicidal ideation or history of attempted suicide

-

history of panic disorder, bipolar depression or any psychotic disorder

-

current substance abuse disorder

-

currently taking psychoactive medications

Notes: Type II diabetes mellitus. Mean duration of diabetes: 9.9 years (SD = 11.8) - treatment & 7.7 years (SD = 7.0) - control.

Baseline: No significant differences at baseline on depression; large but non significant differences between groups on prevalence of complications of diabetes, use of insulin, duration of diabetes. Basline scores of BDI depression: 24.9 (SD = 10.2) - treatment; 21.1 (SD = 6.8) - control.
Data Used
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
Notes: TAKEN AT: pre- & post-assessment; 6-month FU. **At FU some patients who remained depressed after 10 week treatment were referred to primary care for antidepressant medication or to a psychotherapist.
Group 1 N= 25
  • Group based cognitive and beahvioural skills - CBT - 60 min. 10 weekly sessions. Therapist = licensed psychologist.Behavioural strategies, problem solving, cognitive techniques. All received individual session in diabetes education program. Intervention for depression.
Group 2 N= 26
  • Control - Diabetes education program (also provided to treatment group). 60 min, biweekly, individual sessions during entire treatment period (10 weeks).
Sensitivity analysis not needed, participants recruited for depression; intervention aimed at depression.
Results from this paper:
Quality assessed: +
MANNE2007
Study Type: RCT

Type of Analysis: ITT

Blindness: Open

Duration (days):

Followup: 3-, 6-months

Setting: US, Philadelphia, New Jersey, Delaware, Pennsylvania

Notes: Assigned randomly by research assistant stratified by baseline BDI.

Info on Screening Process: 852 approached; 353 randomised; 297, 263, 225 completed 3-. 6-, 9-month post-assessment.
n= 353

Age: Mean 50

Sex: all females

Diagnosis:
  • 100% Cancer by Current diagnosis
Exclusions:
-

not diagnosed with primary gynecological cancer

-

patient was not receiving active treatment i.e. chemotherapy/radiation or less than 3-months post cancer surgery

-

Karnofsky Performance Status of <80 or an Eastern Cooperative Oncology Group (ECOG) score not equal to 0 or 1

-

did not live within 2H communiting distance from recruitment centre

-

less than 18 y/o

-

was not Engligh speaking

-

hearing impaired

Notes: Gynecological cancer: 81.8% ovarian; endometrial (6.5%); primary peritoneal 6.2%; cervical 3.1%; vaginal 0.6%; vulvar (0.6%); uterine 1.1%, fallopian tube cancer 0.6%.

Baseline: No significant differences at baseline for depression. BDI-21 depression scores at baseline: 13.51 (SD = 7.7) - cognitive and behavioural; 14.47 (SD = 9.06) - supportive counseling; 12.51 (SD = 7.86) - TAU.
Data Used
  • BDI-21 item
Data Not Used
  • Physical health outcomes (self-report) - no da
Notes: TAKEN AT: pre-, post-treatment (3-months from baseline), 3-, 6-month FU (6-. 9-months from baseline). DROP OUTS: 47 - cognitive-behavioural; 41 - supportive counseling 40/111 TAU.
Group 1 N= 122
  • Individual based cognitive and behavioural skills - 6 × 1H individual sessions + phone booster session. Aim: coping/support skills; identifying & dealing with emotional reactions to cancer. Techniques from cognitive-behavioural int. Homework assig. Educational material. Therapist = social work/psychologist
Group 2 N= 120
  • Counseling - 6 × 1H individual sessions + phone booster session. Aim: emotional expression, support existing coping behaviours, enhanced self-esteem & autonommy. Conversational in style. Discuss reactions to cancer. Manualized. Therapist = social work/psychologist
Group 3 N= 111
  • TAU - Social work consultations. Referrals to a psychiatrist/pyschologist could be made by physician.
Perform sensitivty analysis - particpants not recruited for depression ; sub-group: intervention for psychosocial stressors.
Results from this paper:
Quality assessed: +
MARKOWITZ1998
Study Type: RCT

Study Description: * included participants who refused randomisation (n=4) or received minimal treatment (n=15).

Type of Analysis: *ITT

Blindness: Open

Duration (days): Mean 119

Setting: USA
Outpatient

Notes: Randomly assigned patients to treatment in a balanced design using a computer-generated random number sequence sealed in individual envelopes.

Info on Screening Process: Details not reported.
n= 101

Age: Mean 37 Range 24-59

Sex: 86 males 15 females

Diagnosis:
  • 100% HIV by Not specified
  • 53% Depression by DSM-III-R
Exclusions:
-

not HIV-positive for 6 months or more

-

a score of 14 or less on the HDRS-24 item

-

not judged by clinican to have significant depressive symptoms

-

poor physical health that inhibits outpatient treatment

-

non-HIV medical disease

-

schizophrenia, bipolar disoder, current substance abuse

-

contraindication to imipramine

-

MMSE score < 25

-

inability to speak english

-

concurrent psychiatric treatment aside from HIV self-help or support groups

Notes: Baseline mean Karnofsky score = 80 (S.D. 6.5); CD4 cell count = 280 (S.D. 222); all clinically judged to have depression.

Baseline: There were no significant differences between groups at baseline. HAM-D (24 items) baseline scores: 20.4 (4.5) - cognitive and behavioural; 20.4 (4.5) - IPT; 20.5 (5.6) IPT + pharm
Data Used
  • 100-point Karnofsky scale
  • CD4 cell count
  • HDRS-24
  • HDRS-17
  • BDI
Notes: TAKEN AT: pre-, mid- and post-intervention.
Group 1 N= 27
  • CBT - Therpasits all PhD psychologists. Homework assigned. 16 × 50 minute sessions within 17-week period. Designed for depression. Individual therapy.
Group 2 N= 24
  • IPT - Modified to psychosocial concerns of depressed HIV-positive patients. 16 × 50 minute sessions within 17-week period. Individual therapy.
Group 3 N= 24
  • Supportive psychotherapy - Ranged between 8 - 16 sessions of 30 - 50 min duration. Added psychoeducation about depression and HIV + client centred approach. Served as control arm in the study. Less structured.
Group 4 N= 26
  • Supportive psychotherapy - Therapy ranged between 8 - 16 sessions of 30 - 50 min duration.
  • Imipramine. Mean dose 210 (S.D. 66) - Begun at 50 mg/d and increases as tolerated to 300 mg/d for 3 - 4 weeks.
Participants recruited for depression and chronic physical health problems. Cognitive-behavioural therapy aimed at reducing depression. IPT modified for physical health problem.
Results from this paper:
Quality assessed: ++
MOHR2000
Study Type: RCT

Type of Analysis: ITT and Completers

Blindness: No mention

Duration (days): Mean 56

Notes: Details on randomisation not reported.

Info on Screening Process: 73 assessed, 39 did not meet inclusion criteria, 2 declined.
n= 32

Age: Mean 42

Sex: 9 males 23 females

Diagnosis: Exclusions:
-

No diagnosis of relapsing MS

-

No treatment with interferon beta-1a

-

Score of < 15 on POMS-Depression-Dejection scale

-

Patients in treatment for depression for < 3 months who did not intend to continue treatment throughout the study

-

Dementia

-

< 5th percentle on the Short Word List

Baseline: There were no significant differences between groups at baseline. Baseline scores of POMS-D = 33.1 - treatment, 27.9 - control.
Data Used Notes: TAKEN AT: pre- and post-intervention. DROP OUTS: 5 CBT; 4 TAU.Group 1 N= 11
  • CBT - Telephone-administrated. Modified for use with MS patients. Homework assignments. Individual therapy. Weekly, 50-min sessions over 8 weeks.
Group 2 N= 12
  • TAU - Usual care available through Kaiser Permanete Medical Care Program of Northern California.
Participants recruited for depression; intervention modified for physical health; telephone admin.

All patients receiving interferon beta-1a; treatment group (1 additional psycotherapy, 1 antidep); control group (1 additional psycotherapy, 2 antidep)
Results from this paper:
Quality assessed: +
MOHR2001
Study Type: RCT

Type of Analysis: ITT

Blindness: No mention

Duration (days): Mean 112

Followup: 6-month follow-up

Setting: USA, California

Notes: 1st 6 patients to still meet MDD criteria after 4 week criteria were assigned to group therapy - less than 6 were assigned to CBT or sertaline

Info on Screening Process: 177 patients showed some signs of depression and received a thorough screening assessment; 63 met inclusion/exclusion criteria.
n= 63

Age: Mean 44

Sex: 17 males 46 females

Diagnosis: Exclusions:
-

an unconfirmed diagnosis of MS

-

a relapsing-remitting or secondary progressive disease course not confirmed by a neurologist

-

no diagnosis of MDD (DSM-IV; SCID)

-

a score less than 16 on the HRSD-17 and BDI

-

unwillingness to abstain from psychological/pharmacological treatment for depression other than that provided during treatment

-

other serious psychological disorders

-

dementia

-

severe suicidality

-

initiation of interferon medication with the previous 2 months

-

other disorders of the CNS

-

current/planned pregnancy

-

current psychological/pharmacological treatment for depression

Baseline: There were no significant differences between groups at baseline. Basline BDI scores: 24.8 - treatment, 23.5 - control. Baseline HAM-D scores: 21.0 - treatment, 20.5 - control.
Data Used
  • Longitudinal Interval Follow-up Evaluation-II
  • HDRS
  • BDI
Notes: TAKEN AT: pre- and post-intervention an at 6-month follow-up.
Group 1 N= 20
  • CBT - 4 psychologists with 1-8 years of postdoctoral experience. Individual therapy. 16 weekly 50 min sessions. Standard CBT + specific skills for management of MS-related symptoms.
Group 2 N= 22
  • Group existential therapy - Group therapy (5-9 patients) for people with medical diagnoses + 2 therapists. 16 weekly 90 min sessions. Aim is to facilitate the emotional expressions related to MS. 5 psychologiss with 1-9 years postdoctoral experience. NOT RANDOMISED TO THERAPY
Group 3 N= 21
  • Sertraline - Initiated at 50 mg per day and increased by 50 mg every 4-weeks until a dosage of 200 mg was reached or until full remission was achieved.
Do not perform sensitivity analysis - participants recruited for depression. Cognitive and behavioural Intervention modified for chronic physical health problem.
Results from this paper:
Quality assessed: +
MOHR2005
Study Type: RCT

Type of Analysis: Completers

Blindness: Single blind

Duration (days): Mean 112

Followup: 12 month

Setting: US

Notes: Details on randomisation not reported. Allocation concealment not addressed.

Info on Screening Process: 748 completed screening, 223 met preliminary criteria, 150 eligible for randomisation, 23 declined, 127 randomised.
n= 127

Age: Mean 47

Sex: 62 males 65 females

Diagnosis: Exclusions:
-

no diagnosis of MS

-

score < 3 on Guy's Neurological Disability Scale

-

score < 16 on BDI and < 14 on HAM-D

-

inability to speak and read English

-

< 18 y/o

-

dementia, psychosis, substance abuse, plan/ intent to committ suicide

-

undergoing psychotherapy

-

currenly experiencing MS exacberation

-

medication other than antidepressants that affect mood

Baseline: Baseline depression scored HAM-D: 21.35 (3.90) - cognitive behavioural, 21.66 (3.53) - psychotherapy; BDI: 27 (7.78) - cognitive behavioural, 28.32 (7.91) - psychotherapy.
Data Used
  • SCID
  • HAM-D
  • BDI-II
Notes: TAKEN AT: baseline, mid-, post-intervention, 3-, 6-, 9-. 12-month FU. DROP OUTS:3/62 cognitive and behavioural; 5/65 psychotherapy.
Group 1 N= 62
  • Individual based cognitive and behavioural skills - telephone administrated. Doctoral level psychologist. 50 min session per week. CBT for depression. Basic CBT skills, behavioural activation, cognitive restructuring, problem solving.
Group 2 N= 65
  • Counseling - telephone administrated. Doctoral level psychologist. 50 min session per week. Goal: to increase individual's experience of their internal world.
Recruited for depression; cognitive and behavioural intervntion aimed at treating depression.
Results from this paper:
Quality assessed: +
SAVARD2006
Study Type: RCT

Study Description: Single blind: assessor blinded to treatment allocation therefore HAM-D is rated blindly

Type of Analysis: Completers*

Blindness: Single blind

Duration (days): Mean 56

Setting: CANADA

Notes: Stratified by location of recruitment; assigned randomly via computer-generated random no. table; group allocation contained in sealed envelopes.

Info on Screening Process: 497 approached; 333 screened; 45 randomised; 37 analysed*
n= 37

Age: Mean 51

Sex: all females

Diagnosis: Exclusions:
-

no diagnosis of metastatic breast cancer (stage IV)

-

a score of <7 on the HADS-D or < 15 on the BDI

-

terminal stage of the disease defined as a life expectancy < 2-months

-

DSM-IV criterial for severe psychiatric disorder other than major depression

-

severe suicidal ideations with risk of acting out - Scale for Suicide Ideation

-

having recently (within the past 2-months) started on antidepressant medication or recently altered the dosage

-

currently receiving a psychological intervention targeting depression

Baseline: No significant differences at baseline for depression; cognitive-behaviour treatment group had longer time passed since initial cancer diagnosis. Baseline BDI scores of depression: 21.13 - treatment, 20.10 - control; HAM-D: 14.21 - treatment, 14.40 - control.
Data Used
  • Physical health outcomes
  • EORTC Quality of Life Questionnaire
  • EORTC Breast Cancer- Specific QoL Questionnaire
  • HAM-D
  • BDI-21 item
  • HADS
Notes: TAKEN AT: pre- and post-treatment; 3-, 6 month FU. DROP OUTS: 4/25 - treatment; 4/20 control - analysed only completers
Group 1 N= 20
  • Control - Waitlist control
Group 2 N= 21
  • Individual based cognitive and behavioural skills - 8 weekly individual sessions. 60-80 min.3 booster sessions every 3 weeks. CBT slightly adapted for women with cancer i.e. targeting negative thoughts specific to cancer. Therapist = licensed psychologist
Do not perforn sensitivity analysis - participants recruited for depression.
Results from this paper:
Quality assessed: +
SIMONI2007
Study Type: RCT

Study Description: Single blind = rater only blinded
*Only participants with non-missing data at each time point were included in analysis

Type of Analysis: *Completers

Blindness: Single blind

Duration (days): Mean 90

Followup: 3-month

Setting: US, New York
HIV primary care outpatient clinic

Notes: Randomisation based on a compueter-generate sequence prepared by an external statistician. Allocation concealment via numbered, opaque, sealed envelop

Info on Screening Process: 53% of eligile patients approached declined; 71 assign to treatment, 59 (83%) completed FU; 65 assign to control, 57 (88%) completed FU.
n= 136

Age: Mean 43

Sex: 75 males 61 females

Diagnosis:
  • 100% HIV by Current diagnosis
Exclusions:
-

less than 18 years

-

not proficient in English

-

not prescribed on HAART regimen

-

with dementia or psychosis

Notes: Years since HIV diagnosis: 7.8 years (SD = 4.6)

Baseline: No significant differences at baseline for outcome measures. Baseline scores of CES-D depression: 19.9 (SD = 12.4) - treatment, 19.6 (SD = 11.2) - control.
Data Used
  • Physical health outcomes
  • CES-D
Notes: TAKEN AT: pre- and post-intervention & 3 month FU.
Group 1 N= 71
  • Peer Support - Delivered by trained peers who = HIV+ & on HAART. 3-months, 6 twice-monthly 1H group therapy @ clinic. Plus, 3 × weekly phone calls from trained peers who were assigned to individ by researcher. Discussed shared experiences in groups/problem-solving.
Group 2 N= 65
  • TAU - Standard medical care from the clinic. Were given social & mental health referrals when requested.
Perform sensitivity analysis as participants were not recruited for depression and physical health problems.
Results from this paper:
Quality assessed: +
SIMS2009
Study Type: RCT

Study Description: **Does not include 2 DROP OUTS in the control group

Type of Analysis: ITT**

Blindness: No mention

Duration (days): Mean 70

Setting: Australia, Community

Notes: Randomisation by independent person using computer generated block randomisation list. Allocation concealment not addressed.

Info on Screening Process: 1550 invited, 233 responded, 104 depressed, 59 medical exclusions, 45 entered trial.

n= 45

Age: Range 21-93

Sex: 27 males 18 females

Diagnosis: Exclusions:
-

stroke < 6 months ago

-

inability to walk a distance of at least 20m independently with or without a gait assistive device

-

< 18 years

-

PHQ-9 < 5

-

depression with psychotic features

-

alcohol or drug related depression

-

schizophrenia, bipolar disorder, dementia other psychiatric diagnoses

-

suicidal ideation

-

terminally ill, uncontrolled hypertension, unstale insulin dependent diabetes & unstable angina

Baseline: Differences in baseline depression scores: intervention (CES-D) 15.43 (sd 7.49); control (CES-D) 23.27 (sd 8.86).
Data Used
  • Remission (below cut-off)
  • SF-12
  • Quality of Life Index
  • CES-D
Notes: TAKEN AT: baseline, post-intervention & 6-month FU. DROP OUTS: 2/22 control group; 0/23 intervention group.
Group 1 N= 23
  • Exercise - Group based. X2 per week for 10 weeks. Supervised by fitness trainer. Each session cost $5. Moderate intensity strengthening excercises/resistance training.
Group 2 N= 22
  • Waitlist - Waitlist controls receiving usual care.
Recruited for depression.
Results from this paper:
Quality assessed: +
SIMSON2008
Study Type: RCT

Blindness: No mention

Duration (days): Mean 35 Range 21-77

Setting: GERMANY
Inpatient

Notes: Randomisation procedure not reported. Allocation concealment not addressed.

Info on Screening Process: 111 screened.
n= 30

Age: Mean 60

Sex: 17 males 13 females

Diagnosis: Exclusions:
-

dementia

-

insufficient German language skills

-

expected inpatient care for > 3 weeks

-

age > 75 years

Baseline: No significant differences.
Data Used
  • HADS
Notes: TAKEN AT: baseline and post-intervention (discharged from hospital). DROP OUTS: none reported.
Group 1 N= 15
  • Group existential therapy - An average of 5 sessions, 30 min, weekly.
Group 2 N= 15
  • TAU - Standard treatment, including medical and surgical care.
Recruited for depression.
Results from this paper:
Quality assessed: +
STEIN2007
Study Type: RCT

Type of Analysis: Completers

Blindness: No mention

Duration (days): Mean 122

Setting: 514 screened, 69 ineligible, 180 refused, 177 assessed & randomised, 79 (90%) - treatment & 81 (91%) - control completed FU (N = 160 at FU)
n= 160

Age: Mean 40

Sex: 90 males 70 females

Diagnosis:
  • 100% HIV by Not specified
Exclusions:
-

less than 18 years

-

did not speak either English or Spanish

-

did not have regular access to a telephone

-

did not have competency to sign informed consent

-

did not have a BDI score > 9

Notes: HIV + for 91.0 (SD = 72.9) months; 28.1% diagnosed within the last 12-months.

Baseline: No significant differences at baseline. The mean BDI score at baseline was 22.7 (SD = 9.6): 40% in the mild to moderate stage, 36.3% moderate to severe and 23.8% severely depressed.
Data Used
  • Response (>50 reduction from baseline)
  • Remission (below cut-off)
Notes: TAKEN AT: pre- and post-intervention. DROP OUTS: 9 (90%) - treatment & 81 (91%) - control completed FU (N = 160 at FU)
Group 1 N= 88
  • Control - Assessment only condition.
Group 2 N= 79
  • Self-help - Participant + nominated peer. Resource Guide locating sources for support. Delivered by telephone. Therapist = social worker/clinical psychologist/nurse. Family functioning, HIV educ + psycho-educ. 22 weeks of treatment, max 12 calls. McMaster model
Do not need to perform sensitivity analysis as participants recruited for depression & physical health problems.
Results from this paper:
Quality assessed: +
WEISS2003
Study Type: RCT

Type of Analysis: Completers

Blindness: No mention

Duration (days): Mean 16

Setting: Netherlands

Notes: Randomisation using a computerized minimisation program.

Info on Screening Process: 150 contacted study staff; 116 completed screening, 110 accepted; 85 randomised.
n= 84

Age: Mean 39

Sex: all males

Diagnosis:
  • AIDS by Current diagnosis
Exclusions:
-

men not between the ages of 18 and 65 years

-

not HIV-positive for at least 6-months

-

inadequate Dutch

-

current alcohol or drug abuse

-

current psychotic symptoms

Notes: Participants known about daignosis for an overage of 4 years, 65% were asymptomatics & 62% were not using antiretroviral medication at baseline.

Baseline: No significant differences between groups at baseline. Baseline BDI scores = 10.3 (SD = 7.3) - treatment; 11.0 (SD = 6.6) - control.
Data Used
  • POMS-D
  • BDI-21 item
Notes: TAKEN AT: baseline, 4-months, 9-month (post-treatment), 6-month FU. DROP OUTS: 4/4 (treatment); 7/41 (control)
Group 1 N= 44
  • Group existential therapy - 17 weekly 2.5 H sessions (over 4-months) + 5-monthly maintenance sessions. Group therapy (6-8). Techniques: stress management; sharing feelings; interpersonal relationships; developing hope. Psychotherapists.
Group 2 N= 41
  • Control - Education: writtien information about HIV infection. Delivered to both treatment and control.
Perform sensitivity analysis as participants are not recruited for depression. Subthreshold depression
Results from this paper:
Quality assessed: +
YU2006
Study Type: RCT

Blindness: Single blind

Duration (days): Mean 84

Followup: None

Setting: CHINA

Notes: Details on randomisation not reported. Allocation concealment not addressed.

Info on Screening Process: Details not reported.
n= 121

Age: Mean 76

Sex: 68 males 53 females

Diagnosis:
  • 100% Cardiovascular disease
Exclusions:
-

presence of physical impairment or cognitive deterioration interdering with relaxation

-

unconrolled angina

-

unstable / acute heart failure, acute systematic illness, recenet injurious fall

-

pre-existing psychiatric diagnosis or current use of antianxiety, anti-depressant use

-

prior relaxation training or use of relaxation techniques

-

current participation in any rehabilitation program

Baseline: No significant differences at baseline. Baseline HADS 11.22 (2.69) - relaxation; 13.13 (4.52) - control.
Data Used
  • Quality of Life Index
  • HADS
Notes: TAKEN AT: baseline and at 12-weeks.
Group 1 N= 59
  • Relaxation training - 2 sessions + revision session. Sucessive muscle groups tenses, relaxed. Bi-weekly telephone calls to enoucage practice over 12 weeks.
Group 2 N= 32
  • Control - Research nurse made a total of 8 phone calls to participants. Attention placebo.
Participants not recruited for depression.
Results from this paper:
Quality assessed: +

From: Appendix 18, Clinical study characteristics tables

Cover of Depression in Adults with a Chronic Physical Health Problem
Depression in Adults with a Chronic Physical Health Problem: Treatment and Management.
NICE Clinical Guidelines, No. 91.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2010.
© NCCMH. All rights reserved.

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