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Characteristics of Included Studies

MethodsParticipantsOutcomesInterventionsNotes
COTTRAUX1990
Study Type: RCT

Study Description: Allocation: random (no details); independent assessor blind to ratings Study duration: 15-day washout+24 weeks treatment+6-month- & 1-year follow-up

Blindness: Single blind

Duration (days):

Setting: Outpatient

Notes: Country of study: France;
Analysis:completer
During 1 year follow-up, some patients remained on serotonergic drugs, some were shifted to clomipramine

Info on Screening Process: 65 screened
N= 60

Age: Mean 36

Sex: 16 males 28 females

Diagnosis: Exclusions: Primary diagnosis of major depressive disorder, patients with Gilles de la Tourette disorder, organic mental disorders and schizophrenia, patients were taking MAOI, barbituates, clormethiazole, phenothiazines, butyrophenones, and neuroleptics, benzodiazepines apart from occasional use of bromazepam up to 6mg/d

Notes: Mean duration of illness in 44 completers 13 years, 51 had previous antidepressant treatment, 10 received ECT, 12 were failures of psychodynamic treatments or psychoanalysis, 3 received behaviour therapy without success, 2 presented pure obsessions
Data Used
  • Global criterion of improvement (duration/rituals)
  • Target rituals (self rated): discomfort
  • Target rituals (self rated): duration of rituals
  • Target rituals (self rated): time
  • Target rituals(assessor rated):duration of rituals
  • Retardation scale
  • Target rituals (assessor rated): time
  • Leaving study early due to adverse events
  • Target rituals (assessor rated): discomfort
  • Hamilton Rating Scale for Depression
  • Beck Depression Inventory
  • Montgomery-Asberg Depression Rating Scale
  • Behavioural Avoidance Test - Avoidance
  • Behavioural Avoidance Test - Discomfort
  • Compulsive activity checlist
  • Leaving study early
Group 1 N= 20
  • BT + Placebo - Exposure + placebo (see Fluvoxamine + Exposure therapy details for Exposure method)
Group 2 N= 20
  • Fluvoxamine + exposure therapy - fluvoxamine up to 300mg; exposure homework & flooding in fantasy for 8 weeks, guided exposure and response prevention for a further 16 weeks. Couple therapy, cognitive restructuring, flooding in fantasy and assertive training was added, upto 25 sessions
Group 3 N= 20
  • Fluvoxamine + antiexposure therapy - fluvoxamine up to 300mg; antiexposure involved asking patients to avoid any kind of exposure to feared situations, to relax at a fixed period daily, to let rituals and/or obsessive thoughts to just happen, patients were given an explanatory manual
Global criterion of improvement: >30% reduction in duration of rituals per day
FOA1992
Study Type: RCT

Study Description: Allocation: random (no details); drugs administered double-blind Duration of study: 22 weeks plus 9-month, 1 yr and 2 yr follow-ups

Blindness: Double blind

Duration (days):

Setting: Outpatient and inpatient

Notes: Country of study: US; Analysis: completer

Info on Screening Process: 80 met OCD criteria, 48 entered the study
N= 48

Age: Mean 33

Sex: 25 males 13 females

Diagnosis: Exclusions: OC symptom duration less than 1 year, current major depression, psychosis, organic mental disorder, and current substance abuse

Notes: Mean age at symptom onset 24.1+-18.4 years, for 26 patients main ritual was washing/cleaning, for 12 patients main ritual was checking/repeating
Data Used
  • OC symptoms: fear (self-rated)
  • OC symptoms: fear (assessor rated)
  • OC symptoms: compulsive symptoms (self-rated)
  • OC symptoms: compulsive symptoms (assessor rated)
  • OC symptoms: avoidance (self-rated)
  • OC symptoms: avoidance (assessor rated)
  • Social Adjustment Scale (self-rated)
  • Compulsive activity checlist
  • State-Anxiety Inventory
  • Hamilton Rating Scale for Depression
  • Beck Depression Inventory
Group 1 N= 10
Mild-depressed placebo - see “
Group 2 N= 9
  • High-depressed Imipramine - first 6 wks drug only: increased up to 250mg by 3 wks, mean daily dose 229mg BT: 15 daily 2-hr sessions over next 3 wks, at 4th wk home-visits by therapists for 4 hours on 2 days, BT consisted of ERP and imaginal exposure, 12 weeks of supportive therapy
Group 3 N= 10
  • High-depressed placebo - see “High-depressed imipramine
Group 4 N= 9
  • Mild-depressed imipramine - see “High-depressed imipramine”
Follow-up at 6 months, 12 months and 24 months not extractable as n in each group not reported
FOA2005
Study Type: RCT

Study Description: Allocation: random (no details); indepentent assessor blind to randomization
Duration of study: acute phase 12 weeks + discontinuation phase 12 weeks

Blindness: Single blind

Duration (days):

Setting: Outpatient

Notes: Country of study: US

Info on Screening Process: 833 screened, 312 did not meet criteria: no OCD (93), received EX/RP or CMI (117), excluded for medical reason (22), comorbidity (75), other reasons (5), unwilling to participate (65), refused to receive CMI (56), or EX/RP (54) or placebo (6), other (191)
N= 122

Age: Mean 35

Sex: 64 males 58 females

Diagnosis:
  • Obsessive-compulsive neurosis by DSM-III-R
Exclusions: Aged <18 and >70 years, OCD duration <1 year, Y-BOCS<17, current major depression, HAM-D>18, substance abuse or dependence within past 6 months, current schizotypal or borderline personality disorder, previous intensive treatment with CMI or ERP

Notes: Duration of illness 16.4 years, baseline Y-BOCS scores 25
Data Used
  • Responders (CGI)
  • Yale-Brown Obsessive-Compulsive Scale: total
  • Leaving study early
  • Clinical Global Impressions
  • Adverse events
  • NIMH-OC
Group 1 N= 36
  • Clomipramine - Fixed dose first 5 weeks, starting at 25mg/d, increasing to 200mg/d, increased to 250mg/d as tolerated, mean final dose 196mg/d
Group 2 N= 26
  • Placebo - Mean final dose for 209mg/d
Group 3 N= 29
  • Exposure + response prevention - 15 2-hr sessions over first 3 weeks and 2 home visits, weekly 45 min meetings for remaining 8 weeks, imaginal and in vivo exposure performed
Group 4 N= 31
  • BT + clomipramine - ERP + CMI, patients met individually with both a therapist and a psychopharmacologist, mean final dose 163+-65mg/d
Responders: CGI=<2
HOHAGEN1998
Study Type: RCT

Study Description: Allocation: random (no details); medication administered double-blind Patients recruited from University hospitals Duration of study: 8 weeks

Blindness: Double blind

Duration (days):

Setting: inpatient

Notes: Country of study: Germany; Analysis:ITT

Info on Screening Process: 60 recruited, 2 dropped out, one because of nausea and stomach upset, other because of acute suicidal tendencies
N= 49

Age: Mean 35

Sex: 20 males 29 females

Diagnosis: Exclusions: OCD secondary to affective disorder or schizophrenia; Y-BOCS<=16; lifetime diagnosis of psychotic disorder, drug or alcohol abuse, organic psychosyndromes, epilepsy or acute suicidal tendency and pregnancy, concurrently using thyroid medicaiton, alpha-or beta-blockers or other psychoactive substances; not medication-free within 7 days of study

Notes: Baseline Y-BOCS 28.2+-3.4; mean OCD duration 11.7+-11.6 years
Comorbid disorders: 47% Axis I disorder, 53.1% personality disorder
Data Used
  • Clinical Global Impressions
  • Symptom Checklist-90
  • Hamilton Rating Scale for Depression
  • Responders (35% Y-BOCS)
  • Yale-Brown Obsessive-Compulsive Scale: total
Group 1 N= 25
  • BT + Placebo - BT: used a multimodal psychotherapy approach; behavior analysis wks 0-3; ERP wks 4-8, exposure comprised 3 levels: therapist-aided, co-therapist aided, self-management.
  • Exposure began in clincial environment, then conducted at home Placebo: as in BT+fluv
Group 2 N= 24
  • Fluvoxamine + BT - Fluvoxamine: initial dose 50mg, increased weekly by 50mg to 300mg in 5 weeks, unless side-effects became intolerable. If side-effects occurred, dose reduced by 50mg in a double-blind manner. Mean dose 288.1mg (range 250-300mg) BT: see BT + placebo
MARKS1980
Study Type: RCT

Study Description: Allocation: random (no details), assessors blind to treatment group Study duration: 4 weeks drug only + 3 weeks exposure or relax + 3 weeks exposure

Blindness: Single blind

Duration (days):

Setting: Initial 4 weeks drugs-only phase in outpatient setting, 6 weeks of psychological treatment in inpatient setting, after which patients were discharged

Notes: Country of study: UK; analysis: ITT Patients referred by psychiatrists and GPs Follow-up at 8, 16, 52 and 104 weeks post treatment
N= 40

Age: Mean 35

Sex: 11 males 29 females

Diagnosis: Exclusions: Mild obsessive-compulsive rituals less than one year's duration, aged <18 and >59 years, history of psychosis, did not agree to involve relatives in treatment, previous adequate behavioural treatment

Notes: Mean duration of illness 11.75 years,
Data Used
  • Wakefield Inventory
  • Hamilton Rating Scale for Depression
  • Behavioural avoidance test - Performance
  • Behavioural Avoidance Test - Discomfort
  • Compulsive activity checlist
  • Target rituals (self rated): time
  • Target rituals (self rated): discomfort
  • Target rituals (assessor rated): time
  • Target rituals (assessor rated): discomfort
Group 1 N= 10
  • BT + clomipramine - CMI: initial dose 10mg raised to 225mg, continued for next 8 months
  • Exposure: Included modelling and retraining of day-to-day ritualistic habits, patients instructed to carrout out exposure tasks between sessions and to keep records of their performance
Group 2 N= 10
  • Placebo + relaxation - Pbo: initial dose 10mg raised to 225mg, continued for next 8 months
  • Relaxation: 45 min daily, after 15 sessions (week 7) switched to exposure, patients instructed by tape-recorder and modelling by therapist to tense and relax body parts alternately
Group 3 N= 10
  • Clomipramine + relaxation - CMI: initial dose 10mg raised to 225mg, continued for next 8 months
  • Relaxation: 45 min daily, after 15 sessions (week 7) switched to exposure, patients instructed by tape-recorder and modelling by therapist to tense and relax body parts alternately
Group 4 N= 10
  • BT + Placebo - Therapist modelled activities which the patient avoided, then refrained from ritualizing. Patients practiced this on day-to-day rituals and were instructed to carry out exposure tasks between sessions and to keep records of their performance
Anxiety, lesiure, sex, family, social life and work adjustment was rated on 0-8 point scales used by Gelder and Marks (1966) Wakefield Inventory is a modified and shortened version of the Zung depression rating scale
NEZIROGLU2000
Study Type: RCT

Study Description: Allocation: random (no details)
Duration of study: 10 weeks FLX + 33 weeks

BT or FLX + 9 weeks FLX

Blindness: Open

Duration (days):

Setting: Not reported

Notes: Country of study: US; Analysis: ITT

Info on Screening Process: Not reported
N= 10

Age: Mean 14 Range 10-17

Sex: 6 males 4 females

Diagnosis: Notes: Mean age of OCD onset 9.9+-11.7 years
Included patients who had previously failed to comply with BT

Comorbid disorders: ADHD (n=2), trichotillomania (n=1)
Data Used
  • Clinical Global Impressions: global improvement
  • Clinical Global Impressions: severity
  • NIMH Global OCD Scale
  • Yale-Brown Obsessive-Compulsive Scale: total
  • Responder (MDD)
Group 1 N= 5
  • Fluvoxamine + BT - Fluvoxamine alone first 10 weeks, 20 BT sessions 90 min, once a week over 33 weeks, BT consisted of ERP. Following ERP, 4 patients continued with fluvoxamine until week 52
Group 2 N= 5
  • Fluvoxamine - Fluvoxamine adminstered from baseline to week 52, initial dose 50mg/d increased over the first month to a maximal dose of 200 mg/d at 50mg increments. Patients were kept at 200mg during all phases including maintenance.
POTS2004
Study Type: RCT

Study Description: Allocation: random (computer-generated sequence in blocks of 4), double-blind concealment in medication conditions only, assessors blind to treatment

Blindness: Double blind

Duration (days):

Followup: 12 weeks

Setting: Outpatient

Notes: Country of study: US, conducted at 3 sites, Analysis: ITT

Info on Screening Process: 154 screened, 31 deemed ineligible, 10 not interested, 1 asymptomatic at baseline
N= 112

Age: Mean 12

Sex: 56 males 56 females

Diagnosis: Exclusions: Aged <7 and >17 years, CY-BOCS<17, NIMH Global Severity Score<8, IQ<81 as measured by Block Design and Vocabulary subtests in Wechesler Intelligence Scale for Children, major depression, bipolar illness, primary diagnosis of Tourette disorder, pervasive developmental disorder, psychosis, concurrent treatment with psychotropic medication, previous failed trials with SRIs or CBT, sertraline intolerance, medical or neurological disorder, pregnancy, history of remission following medication, CBT or combination

Notes: Baseline CY-BOCS 24.6, 80% had at least 1 psychiatric comorbid disorder, 63% had affective or anxiety disorders, 27% had ADHD, oppositional defiant disorder or conduct disorder, 16% had comorbid tic disorder
Data Used
  • Children's Yale-Brown Obsessive-Compulsive Scale
  • Leaving study early due to adverse events
  • Leaving study early
Group 1 N= 28 Group 2 N= 28
  • Sertraline - Initial dose 25mg/d, increased to 200mg/d over 6 weeks in a fixed flexible upward titration, after which dosage could be adjusted as tolerated
Group 3 N= 28
  • CBT + Medication - CBT and sertraline treatment began simultaneously and followed the same protocol as for the individual interventions
Group 4 N= 28
  • Placebo
VANBALKOM1998
Study Type: RCT

Study Description: Allocation: random (no details)
Duration of study: 8 wks + 8 wks
Participants were GP referrals and mental health agencies, responders to media ad

Blindness: No mention

Duration (days):

Setting: Outpatient

Notes: Country of study: Netherlands; Analysis: completer

Info on Screening Process: 152, 35 declined participation (refused randomization to pharmacological treatment) (16), waiting list condition (5), or CBT(1), not willing to stop antidepressants or neuroleptics (5), other (8)
N= 117

Age: Mean 35

Sex: 30 males 40 females

Diagnosis: Exclusions: OCD duration<1 year, patients with obsessions only, organic mental disorders, psychotic disorders, psychoactive substance use, mental retardation, other severe mental disorders, SSRI medication in 6 months before study, pregnancy

Notes: Mean OCD duration in completers (N=70) 12.5 +-10.4 years. All therapists (5 psychologists and 1 psychiatrist) were experienced with BT for OCD and received training in cognitive therapy
Data Used
  • Leaving study early
  • Symptom Checklist-90: OC
  • Beck Depression Inventory
  • Anxiety Discomfort Scale
  • Yale-Brown Obsessive-Compulsive Scale: total
Group 1 N= 25
  • Cognitive therapy - 16 45-minute sessions for first 8 weeks, patients learned to consider intrusions as stimuli and to identify anxiety evoking automatic thoughts, which were challenged & replaced by alternative, rational, nondistressing thoughts, used Socratic Dialogue
Group 2 N= 22
  • Individual BT - 16 sessions lasting 45 minutes, exposure in vivo with response prevention. After all compulsions and avoidance behaviour were inventoried, a fear hierarchy was made, and exposure homework was assigned, patients were asked to keep homework diaries
Group 3 N= 28
  • Fluvoxamine + BT - Patients received 6 30-minute sessions of fluvoxamine only during first 8 weeks, fluvoxamine started at 50mg every night, increased upto maximum 300mg/d based on patient response, during next 10 sessions, behavioural therapy added to fluvoxamine treatment
Group 4 N= 24
  • Fluvoxamine + CT - Patients received 6 30-minute sessions of fluvoxamine only during first 8 weeks, fluvoxamine started at 50mg every night, increased upto maximum 300mg/d based on patient response, during next 10 sessions, cognitive therapy added to fluvoxamine treatment
Group 5 N= 18
  • Wait list control - Lasted for 8 weeks

From: Appendix 16, Characteristics of reviewed studies

Cover of Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder: Core Interventions in the Treatment of Obsessive-Compulsive Disorder and Body Dysmorphic Disorder.
NICE Clinical Guidelines, No. 31.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2006.
© NCCMH. All rights reserved.

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