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Neurofeedback and Biofeedback for Mood and Anxiety Disorders: A Review of Clinical Effectiveness and Guidelines

CADTH Rapid Response Report: Summary With Critical Appraisal

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Context and Policy Issues

Mood and anxiety disorders are among the common types of mental disorders in Canada. 1 According to a 2013 estimate for Canada, three million (11.6%) people of age 18 years or older reported that they had a mood and/or anxiety disorder.1 Mood and anxiety disorders include various psychiatric disorders of which post-traumatic disorder (PTSD), generalized anxiety disorder (GAD) and depression are the focus of this review. These are debilitating conditions and associated with considerable personal, societal and economic costs.2-4 PTSD involves recurring intrusive recollections of a traumatic event, with recollections beginning within the firstsix months and lasting over one month. 5 GAD is characterized by intense anxiety and worry regarding several events or activities that persist most days during at leastsix months and is difficult to control.6 Depressive disorders are characterized by severe and persistent sadness which interferes with normal function and frequently results in lack of interest or pleasure in activities.7 Treatment options for these disorders generally include pharmacotherapy or psychotherapy. However, not all patients respond to these therapies and some patients may experience adverse effects.8

Biofeedback (BF) is a non-invasive psychophysiological treatment technique with a bio-monitoring system and sensors to measure, amplify, and feedback information that enables an individual to learn how to change physiological activity (such as respiration, heart rate variability, blood flow and blood pressure) and thus improve health and performance.9-11 There is some speculation regarding home use BF devices. Home use BF device may allow an individual to self-treat in the comfort of their home and decrease travel to clinics to receive training; however, visits with the health professional may still be needed and adherence may be an issue for some individuals.

Neurofeedback is a specific type of biofeedback.12 Neurofeedback focusses on the central nervous system and the brain to improve neuro regulation and stabilization.13,14 Modulation of brain activity can affect behavioral changes.15 NF trains the patient to improve poorly regulated brainwave patterns by using computer technology.11 Feedback is provided to the patient in real time using sounds or video images; positive feedback or negative feedback depending on whether the desired brain activity is achieved or not achieved.11 There appears to be some debate regarding the therapeutic role of biofeedback and neurofeedback for the treatment of patients with psychiatric disorders.8,15

Two previous CADTH Rapid Response reviews10,16 reported on neurofeedback and biofeedback for mood and anxiety disorders. The review10 published in 2012 reported that evidence from mostly preliminary analyses suggested that neurofeedback and biofeedback may have potential for the treatment of PTSD, GAD, or depression. The review16 published in 2014, assessed evidence identified since the publication of the review10 of 2012 and reported that limited evidence suggested that biofeedback may decrease the symptoms of PTSD or depression. Both the reviews10,16 reported that no relevant evidence based guidelines on neurofeedback or biofeedback were identified. The purpose of this review is to evaluate the more recent evidence regarding the clinical effectiveness of neurofeedback or biofeedback compared with other modalities for the treatment of mood and anxiety disorders (PTSD, GAD, or depression) in adults. Additionally, this review aims to review recent evidence-based guidelines regarding the use of neurofeedback or biofeedback for the treatment of mood and anxiety disorders (PTSD, GAD, or depression) in adults.

Research Question

  1. What is the clinical effectiveness of neurofeedback provided by a health professional for mood or anxiety disorders in adults?
  2. What is the clinical effectiveness of biofeedback provided by a health professional for mood or anxiety disorders in adults?
  3. What is the clinical effectiveness of biofeedback using home equipment for mood or anxiety disorders in adults?
  4. What are the evidence-based guidelines regarding the use of neurofeedback or biofeedback for the treatment of mood and anxiety disorders in adults?

Key Findings

Evidence from single randomized controlled trials suggests that compared with no treatment there is a statistically significant improvement in symptoms with neurofeedback treatment in patients with post-traumatic stress disorder (PTSD) or generalized anxiety disorder (GAD).

A single randomized controlled trial (RCT) showed that for patients with PTSD there was improvement in symptoms with biofeedback (BF) plus treatment as usual (TAU) and also with TAU alone but the improvement occurred faster in the BF plus TAU group. A single RCT showed that for patients with PTSD there were no between group differences for BF and various mindfulness related treatment modalities.

A single RCT showed that for patients with major depressive disorder, there was a statistically significant improvement in depression with BF plus TAU.

Results need to be interpreted in the light of limitations (such as small sample size, lack of randomization details, lack of reporting of adverse events, lack of long-term data).

No relevant studies on the clinical effectiveness of biofeedback using home equipment for treatment of PTSD, GAD, or depression without continued support from health professionals were identified.

No relevant evidence based guidelines regarding the use of neurofeedback or biofeedback for the treatment of PTSD, GAD, or depression were identified.

Methods

Literature Search Methods

This report makes use of a literature search developed for a previous CADTH report. The original literature search was conducted in July 2014 on key resources including Medline, PubMed, PsycInfo, and The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. The initial search was also limited to English-language documents published between January 1, 2012 and July 28, 2014. For the current report, database searches were rerun on October 16, 2017 to capture any articles published since the initial search date. The search of major health technology agencies was also updated to include documents published since July 2014.

Selection Criteria and Methods

One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.

Table 1. Selection Criteria.

Table 1

Selection Criteria.

Exclusion Criteria

Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications, or were published prior to 2014. For articles published in 2014, there may be possibility of some overlap of articles identified in the previous CADTH report16 literature search and in this current report, hence articles identified by the current literature search which were already included in the previous review 16 were not considered here. Studies comparing different NF methods (such as using different brain locations) were excluded. Guidelines that were not evidence-based were excluded.

Critical Appraisal of Individual Studies

The included randomized studies were critically appraised using Downs and Black checklist.17 Summary scores were not calculated for the included studies; rather, a review of the strengths and limitations of each included study were narratively described.

Summary of Evidence

Quantity of Research Available

A total of 368 citations were identified in the literature search. Following screening of titles and abstracts, 350 citations were excluded and 18 potentially relevant reports from the electronic search were retrieved for full-text review. No potentially relevant publications were retrieved from the grey literature search. Of these potentially relevant articles, 13 publications were excluded for various reasons, while five publications met the inclusion criteria and were included in this report. These comprised five randomized controlled trial (RCT) reports.6,14,18-20 Appendix 1 describes the PRISMA flowchart of the study selection.

Summary of Study Characteristics

Study characteristics are summarized below and details are presented in Appendix 2, Tables 2 and 3.

Study Design

All five included studies were RCTs.6,14,18-20 In one RCT6 the psychiatrist conducting the diagnostic interview at the beginning and at the end of the study was blinded. In one RCT20 the investigator conducting the analysis was blinded. In three RCTs 14,18,19 blinding was not mentioned.

Country of Origin

Of the five RCTs, two RCTs14,20 were published in 2016 from the USA and three RCTs were published in 2015, one each from Iran,6 the Netherlands,19 and the USA.18

Patient Population

Three RCTs14,19,20 were on PTSD patients, the number of patients ranged between 8 and 102. The proportions of females were 75% and 76% in two RCTs 14,19 on patients with chronic PTSD and 6% in one RCT20 on combat veterans with PTSD. The mean age was 52 years in one RCT,20 and 44 years in one RCT14; the median age was 45 years in one RCT.19

One RCT6 was on 28 patients of mean age 30 years and with GAD. The proportion of males or females was not reported.

One RCT18 was on 20 patients of mean age 20 years with major depressive disorder (MDD). The proportion of males or females was not reported.

Interventions and Comparators

Of the five RCTs, three RCTs18-20 investigated BF and two RCTs6,14 investigated NF. Study duration ranged from six to 12 weeks.

PTSD

One RCT20 compared four treatment modalities: (i) body scan mindfulness meditation (MM), (ii) slow breathing using a biofeedback device (SB), (iii) mindful awareness of breadth with the intent to do slow breathing (MMSB), and (iv) sitting quietly (SQ). One RCT14 compared neurofeedback (NF) with no treatment (i.e., waitlist [WL]). Patients in the WL group did not receive treatment during the study but had the option of receiving NF treatment after the study was completed. One RCT19 compared biofeedback (BF) plus treatment as usual (TAU) with TAU alone. TAU was trauma-focused cognitive behavioral therapy (CBT).

GAD

One RCT6 compared NF with WL. Patients in the WL group did not receive treatment during the study but had the option of receiving NF treatment after the study was completed.

MDD

One RCT18 compared heart rate variability biofeedback (HRV-BF) plus TAU with TAU alone. TAU was psychotherapy; details were not reported.

Outcomes

All five RCTs6,14,18-20 reported on psychological outcomes using various outcome measures, that are specified below according to disease condition. Descriptions of the outcome measures are presented in Appendix 2 Table 3.

PTSD

In one included RCT20 the outcome measures used were Beck Depression Inventory-II (BDI-II), Global Impression of Change (GIC), General Perceived Self-Efficacy scale (GPSE), Positive and Negative Affect Scale (PANAS), PTSD checklist (PCL), Pittsburgh Sleep Quality Index (PSQI), and Perceived Stress Scale (PSS). In the second RCT14 the outcome measures used were Clinician Administered PTSD Scale (CAPS), Davidson Trauma Scale (DTS), Inventory of Altered Self-Capacities (IASC). In the third RCT19 the outcome measure used was Impact of Event Scale-Revised (IES-R).

GAD

In included RCT6 the outcome measures used were General Anxiety Disorder scale(GAD-7), and Global Assessment Functioning Scale (GAFs).

MDD

In the included RCT18 the outcome measures used were BDI-II and Outcome Questionnaire (OQ-45).

Summary of Critical Appraisal

The critical appraisal of the included RCTs is summarized below and details are available in Appendix 3, Table 4.

In all five included RCTs 6,14,18-20 the objective, and inclusion and exclusion criteria were stated, the patient characteristics, interventions and outcomes were described. However details of the randomization procedure were lacking, hence it was unclear if there was any selection bias. The RCTs had restrictive inclusion criteria hence generalizability to a broader patient population other than the study population is unclear. Additional details of the critical appraisal are presented separately for each of the three conditions.

PTSD

Additionally, in all three included RCTs of patients with PTSD14,19,20 mixed model or multilevel model analyses were conducted, as such analyses are not affected by patient attrition or missing data. In one RCT20 the investigator who did the data analysis was blinded and in the other two RCTs14,19 it was unclear if there was any blinding. In one RCT20 sample size calculation was undertaken and the appropriate number was used, one RCT14 was slightly underpowered but treatment effects were statistically significant, hence no issue, and in one RCT19 it was unclear if sample size calculation had been undertaken. In two RCTs14,19 the authors stated that there were no conflicts of interest, and in one RCT20 conflicts of interest were not mentioned.

GAD

Additionally, in the included RCT of patients with GAD6 the psychiatrist assessing the patient pre- and post-treatment was blinded. It was unclear if sample size calculation had been undertaken, if there were any withdrawals, if an intention-to-treat analysis had been undertaken, or if there were any conflicts of interest.

MDD

Additionally, in the included RCT of patients with MDD18 it was unclear if there was any blinding, if sample size calculation had been undertaken, if there were any withdrawals, if an intention-to-treat analysis had been undertaken, or if there were any conflicts of interest.

Summary of Findings

Findings are summarized below and details are available in Appendix 4, Table 5.

What is the clinical effectiveness of neurofeedback provided by a health professional for mood or anxiety disorders in adults?

PTSD

The RCT by van der Kolk et al.14 involving adults with chronic PTSD, compared patients on NF treatment with patients awaiting treatment (i.e., NF versus waitlist [WL]). Both groups showed a statistically significant decrease in PTSD symptoms (as assessed using CAPS) between pre-treatment and 1-month post-treatment, however the decrease was greater for the NF group (decrease in CAPS score: 40.35 for NF and 10.78 for WL). A decrease in CAPS score by 20 is commonly considered as clinically significant. Also, at 1-month post-treatment, there were statistically significant improvements in PTSD symptoms with NF compared to WL, as assessed using DTS and IASC scores.

GAD

The RCT by Dadashi et al.6 compared NF with WL for management of adult patients with GAD. It showed that treatment with NF resulted in a statistically significant increase in the global functioning level and reductions in symptoms of GAD, but such changes were not observed in the WL group.

What is the clinical effectiveness of biofeedback provided by a health professional for mood or anxiety disorders in adults?

PTSD

The RCT by Polak et al.19 compared treatments with BF plus TAU with TAU alone in adults with chronic PTSD. TAU comprised trauma focused CBT. It showed that PTSD symptoms (assessed using IES-R scores) decreased over time for both BF + TAU and TAU treatments, but PTSD symptoms decreased faster with BF + TAU treatment compared with TAU alone (P = 0.051).

The RCT by Wahbeh et al.20 compared MM, SB, MMSB, and SQ for the treatment of adults (combat veterans) with chronic PTSD. Compared to pre-treatment, improvements in some PTSD and related symptoms were observed within each group and appeared to be greatest in the MM group followed sequentially by MMSB, SQ and then SB. For MM, improvements appeared to be statistically significant but for MMSB, SQ, and SB statistically significance was achieved for some outcome measures and not for other outcome measures. The analyses were based on available data and missing data or covariates were not considered. Mixed model analyses showed that overall there were no between-group differences on PTSD symptoms, perceived stress, depression, positive and negative emotions, self-efficacy, and sleep quality.

MDD

The RCT described in the dissertation by Caldwell18 compared treatments with HRV-BF plus TAU with TAU alone in young adult patients with MDD. TAU comprised psychotherapy. This study showed that there was a statistically significant decrease in depression levels (measured using BDI-II and OQ-45) between baseline and post treatment follow-up in the MDD patients receiving HRV-BF in addition to TAU. However, in the MDD patients receiving only TAU there appeared to be a decrease in depression levels between baseline and post treatment follow-up but the difference was not statistically significant. The statistical significance of between group differences was not presented.

What is the clinical effectiveness of biofeedback using home equipment for mood or anxiety disorders in adults?

No relevant studies on the clinical effectiveness of BF using home equipment for treatment of mood and anxiety disorders (PTSD, GAD, or depression) without continued support from health professionals were identified. In three RCTs,18-20 between the scheduled visits with health professionals, the patients were instructed to practice at home the training they had received using BF devices or visual guides. These findings have been presented for question 2 (above).

What are the evidence-based guidelines regarding the use of neurofeedback or biofeedback for the treatment of mood and anxiety disorders in adults?

No relevant evidence-based guidelines regarding the use of NF or BF for the treatment of mood and anxiety disorders (PTSD, GAD, or depression) were identified.

Limitations

No relevant health technology assessments, systematic reviews, and non-randomized studies comparing NF or BF with other modalities for treatment of PTSD, GAD, or depression were identified. In addition, no evidence-based guidelines on NF or BF for treatment of PTSD, GAD, or depression were identified.

A limited number of relevant RCTs were available. The inclusion criteria of the studies were restrictive. Patients with co-morbidities (such as other psychological conditions) were excluded. Hence generalizability of the findings is uncertain.

Comparisons across studies were difficult as the comparators, disease conditions and outcome measures were variable.

The majority of the studies (three of the five included studies) were of small sample size (ranging from 8 to 28). Hence there is potential for underestimation or overestimation of results.

Long term effects of treatments with BF and NF were unclear. For most RCTs, the treatment duration ranged from six weeks to eight weeks with no further follow-up; except in one RCT the treatment duration was12 weeks with one month follow-up post treatment.

None of the studies reported on adverse events.

None of the studies were conducted in Canada hence generalizability to the Canadian setting is limited. However four of the five included studies were from the USA or Europe, hence there may be some similarities.

Findings need to be interpreted in the light of the limitations presented above.

Conclusions and Implications for Decision or Policy Making

Five relevant RCTs.6,14,18-20 comparing NF or BF with other psychological treatments or no treatments for managing patients with PTSD, GAD or MDD were identified. Of these five RCTs, two RCTs6,14 were on NF provided by health professionals, and three RCTs18-20 were on BF provided by health professionals. No relevant studies on the clinical effectiveness of biofeedback using home equipment for treatment of PTSD, GAD, or depression without continued support from health professionals were identified. No relevant evidence based guidelines regarding the use of NF or BF for the treatment of PTSD, GAD, or depression were identified.

The results from two RCTs (one study per condition) suggested that NF may be effective for the treatment of PTSD14 or GAD6 compared with no treatment.

Some evidence was identified to suggest that adding BF to TAU may be more effective than TAU alone. For patients with PTSD, one RCT showed that adding BF to trauma-focused CBT was associated with faster improvements in symptoms than CBT alone,19 while another RCT found no significant differences between BF and mindfulness-based therapies.20 For patients with MDD, one RCT found that patients who received HRV-BF in addition to psychotherapy showed significant improvements in symptoms after treatment, while significant improvements were not achieved with psychotherapy alone.18

Findings need to be interpreted in the light of the limitations (such as small sample size, limited number of relevant studies, lack of randomization details, lack of reporting of adverse event, and lack of long-term data).

References

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Abbreviations

BDI-II

Beck Depression Inventory – II

BF

Biofeedback

CAPS

Clinician Administered PTSD Scale

CBT

cognitive behavioral therapy

CES

Combat Exposure Scale

CI

confidence interval

DSM-IV

Diagnostic and Statistical Manual of Mental Disorders Fourth Edition

DTS

Davidson Trauma Scale

GAD

Generalized Anxiety Disorder

GAD-7

Generalized Anxiety Disorder Scale

GAFs

Global Assessment Functioning Scale

GIC

Global Impression of Change

GPSE

General Perceived Self-Efficacy Scale

HRV-BF

heart rate variability – BF

IASC

Inventory of Altered Self-Capacities

ITT

intention-to-treat

MDD

major depressive disorder

MM

mindfulness meditation

MMSB

mindful awareness of breadth with the intent to slow breathing

NF

neurofeedback

OQ-4

Outcome Questionnaire – 45

PANAS

Positive and Negative Affect Scale

PCL

PTSD Checklist

Post-Tx

post-treatment

Pre-Tx

pre-treatment

PSQI

Pittsburgh Sleep Quality Index

PSS

Perceived Stress Scale

PTSD

post-traumatic stress disorder

RCT

randomized controlled trial

SB

slow breathing using BF

SD

standard deviation

SQ

sitting quietly

SUDS

Subjective Units of Distress

TAU

treatment as usual

TF-CBT

trauma focused cognitive behavioral therapy

WL

waitlist (no treatment)

Appendix 1. Selection of Included Studies

Image app1f1

Appendix 2. Characteristics of Included Publications

Table 2Characteristics of Included Randomized Controlled Trials

Author, Year, CountryStudy DesignPopulation CharacteristicsComparisonOutcome, Follow-up
Caldwell,18 2015, USA (Dissertation)RCT

Setting: Patients were recruited through the Brigham Young University Counseling Center
Adults with MDD in the age range 18 to 25 years. Patients with comorbidities such as cardiovascular disease, alcohol or drug abuse, or any physiological or neurological disorders were excluded.

N = 20 (10 in each group)

Age (mean ± SD) (years): 20.09 ± 1.81 in HRV-BF + TAU group, 20.20 ± 1.47 in TAU group

% Female: NR
HRV-BF + TAU versus TAU

HRV-BF comprised of five HRV training sessions. Firstsession started on the same day that baseline measurements were taken. The firstsession was to teach abdominal breathing and participants were instructed to practice abdominal breathing for 15 to 20 minutes a day for 4 to 5 times a week. The second session was to determine the patient’s optimal breathing rate (i.e. the rate that gets the patient into the greatest oscillation of heart rate). The patients are then instructed to practice with a visual pacer corresponding to their optimal breathing rate for another 3 minutes. Then they were scheduled for three weekly 20 minutes HRV training sessions. Also, they were instructed to practice 15 to 20 minutes a day for 4 to 5 times a week for 3 weeks using visual guides that were available (free) on the internet. At the 3rd, 4th, and 5th session the patientpracticed their optimal breathing rate and breathed in phase with their heart rate for 20 minutes. After the 5th session a follow-up appointment was scheduled. Total time commitment for the patient to participate in the study was 6 weeks.

TAU was psychotherapy (details not presented)
Psychological outcomes (BDI-II, OQ-45)

Physiological measures (not relevant for this report).

Study duration: 6 weeks.
Dadashi,6 2015, IranRCT. The psychiatrist who did the diagnostic interview at the beginning as well as at the end of the study was blinded.

Setting: Patients referred to the Sohrawadi Psychiatric and Clinical Psychology Center in Zanjan, Iran
Adults (age range: 18 to 50 years) with GAD diagnosed by psychiatrist and clinical psychologist. Patients having additional psychological disorders were excluded

N =28 (14 in NF, in WL)

Age (Mean ± SD) (years): 33.67 ± 9.90 in NF, 27.33 ± 6.80 in WL. % Female: NR
NF versus WL (i.e., wait-list control [no intervention])

A NF procomp-5 device was used for 30 minutes of training alpha waves in the occipital area and 30 minutes of training theta waves in the occipital area. The patients received audio feedback in response to the cognitive strategy for enhancing alpha and theta amplitudes higher than a predetermined threshold. Each patient attended 15 NF sessions.

The WL group did not receive any intervention. They were to be treated after completion of the study.
Psychological outcomes (GAD-7, GAFs).

Physiological measures (not relevant for this report).

Study duration was not reported but each patient\s attended 15 sessions. The authors reported that 15 sessions could be completed in 2 months
Polak192015, The NetherlandsRCT

Setting: Patients were from the outpatient clinic of the Academic Medical Center
Adults with chronic PTSD (CAPS scored ≥ 45). Patients with comorbid severe depressive disorders or other Axis 1 disorders were excluded.

N = 8 (4 in each group)

Age (median [range]) (years): 45 (25 to 57)

% Female:75%
BF + TAU versus TAU

TAU was TF-CBT and included exposure (imaginal and in vivo) as key element. Other elements were psychoeducation and anxiety management.

For BF the breathing biofeedback device was introduced in the firstsession and initially every day the patients had to practice using the device in a relaxed state. From the third session onwards the patients were instructed to use the device while focusing on a hotspot during imaginal exposure. When the breathing did not follow the rhythm of the prior programmed breathing frequency, the patient received feedback by a beep sound. There were 9 weekly sessions.
Psychological outcomes (IES-R)

Follow-up: one week post treatment. The number of sessions were based on the SUDS rating system (a 100 point scale with 0 = no anxiety and 100 = extreme anxiety). Sessions (median [range]): 7.5 (6 to 11) for BF+TAU group and 8 (5 to 18) for TAU group.
van der Kolk,14 2016, USARCT

Setting: Patients were recruited using newspaper and radio advertisements, the Trauma center website, and solicitation from mental health professionals. Study data were collected and analyzed at the Traum a center at Justice Resource Institute.
Adults with chronic PTSD who had received weekly trauma-focused psychotherapy for at leastsix months. Patients with comorbid conditions such as unstable medical conditions, suicidal risk psychotic or bipolar disorder, substance use disorders were excluded

N = 52 (28 in NF, 24 in WL)

Age (mean ± SD) (years): 44.40 ± 13.15 (46.04 ± 12.89 in NF, 42.45 ± 13.50 in WL).

% Female: 76% (93% in NF, 77% in WL).

Proportion of patients on medication: 57% in NF, 42% in WL
NF versus WL

Both groups were required to continue all ongoing treatments (psychotherapy and pharmacotherapy)

NF: 12 weeks of twice weekly NF sessions, each lasting up to 30 minutes. Patients received auditory and visual feedback indicating reward

(Control i.e., WL group would later [after study completion] be provided 24 NF sessions after the 12 week evaluation.
Psychological outcomes (CAPS, DTS, IACS)

Treatment duration: 12 weeks and I month follow-up post-treatment
Wahbeh,20 2016, USARCT. The principle investigator did the data analysis and was blinded to patient allocation. The RA providing training to the patients was not blinded.

Setting: Patients were recruited from the Portland Metropolitan Area using flyer postings, advertisements, and local talks. Study was conducted at the Oregon Health & Science University Hatfield Research Center
Adults (combat veterans majority from the Vietnam Era) with PTSD. Patients with other co-morbidities such as significant chronic medical illness, psychiatric or behavioral illness.

N = 114 randomized and 102 competed study (25 in SB, 27 in MM, 25 in MMSB, 25 in SQ)

Age (mean ± SD) (years): 52.1 (52.2 ± 12.5 in SB, 53.3 ± 12.6 in MM, 50.0 ± 12.8 in MMSB, 53 ± 11.8 in SQ).

% Females: 6% (8% in SB, 7% in MM, 4% in MMSB, 4% in SQ).
MM versus SB versus MMSB versus SQ

Patients received training one on one from trained RA, once a week for 6 weeks. The RA was notblinded. Also all patients were asked to practice at home for 20 minutes per day between sessions.

For the mindfulness intervention, the RA read one-page script defining mindfulness. There were no instructional scripts for SB or SQ.
In the MM group the patients practiced the body scan, which is a mindfulness technique. It involves directing one’s attention to different regions of the body, starting with the toes of the left feet and slowly moving upwards.
In the MMSB group, patients satupright, consciously observed their breathing and naturally slowed their breath.
In the SB group patients used a biofeedback device designed to reduce the respiratory rate.
In the SQ group, the patients sat quietly and listened to a neutral-content audiobook in the laboratory sessions.
Psychological outcomes (PCL, PSS, BDI-II, PANAS-N, PANAS-P, GPSE, PSQI, GIC)

Physiological measures (not relevant for this report)

Study duration; 6 weeks

BDI-II = Beck Depression Inventory - II; BF = Biofeedback; CAPS = Clinician Administered PTSD Scale; DTS = Davidson Trauma Scale; GAD-7 = General Anxiety Disorder Scale; GAFs = Global Assessment Functioning Scale; GIC = global impression of change; GPSE = General Perceived Self-Efficacy Scale; HRV-BF = heart rate variability - BF; IASC = Inventory of Altered Self-Capacities; IES-R = Impact of Event Scale-revised; MDD = major depressive disorder; MM = mindfulness meditation (body scan); MMSB = mindful awareness of breadth with the intent to slow breathing; NF = neurofeedback; NR = not reported; OQ-45 = Outcome Questionnaire - 4; PANAS = Positive And Negative Affect Scale; PCL = PTSD checklist; PSQI = Pittsburgh Sleep Quality Index; PSS = Perceived Stress Scale; PTSD = post-traumatic stress disorder; RCT = randomized controlled trial; SB = slow breathing using biofeedback device; SD = standard deviation; SQ = sitting quietly; SUDS = Subjective Units of Distress; TAU = treatment as usual; TF-CBT = trauma focused cognitive behavioral therapy; WL = waitlist.

Table 3Description of Outcome Measures

Outcome MeasureDescription
BDI-IIIt is a 21 -item self-report tool that measures depressive symptoms based on DSM-IV, and has been widely used. It has been tested for internal consistency (alpha coefficient 0.92 and test-retest reliability (correlation 0.93, P < 0.001).20
The total score was 63 with 4 levels of cut-off score. Total score of 0 to 13 indicates minimal depression; 14 to 19 indicates mild depression; 20 to 28 indicate moderate depression; and 29 to 63 indicates severe depression. BDI-II has internal consistency ranging from 0.87 to 0.93, and test-retest reliability of 0.93. It is considered reliable and valid.18
CAPSCAPS has 30-items corresponding to the DSM-IV criteria for PTSD. Each item has two parts: frequency and intensity, and both are scored on a 5-point scale (0 to 4). The frequency and intensity item scores can be summed up to provide a symptom rating that can range from 0 to 136. Higher score indicates worse symptoms. CAPS is considered the gold standard for assessment of PTSD.14
Test-retest reliability studies showed coefficients between 0.90 and 0.98; and internal consistency ranged from 0.85 to 0.87 for symptom clusters, and to 0.94 for the entire scale.20
CESIt is a 7-item Likert scale assessing extent of exposure to combat experience Scores are graded by amounts of exposure:0 to 8 light, 9 to 16 light-moderate, 17 to 24 moderate, 25 to 32 moderate-heavy, and 33 to 41 heavy. It has high internal consistency (alpha = 0.85) and test-retest reliability (correlation 0.97).20
DTSDTS is a self-report measure of PTSD assessing both severity and frequency of PTSD symptoms using a 0 to 4 scale, similar to CAPS. Total score ranges between 0 to 136.14
GAD-7It is a questionnaire with 7 items. Each item is scored between 0 and 3. The total score ranges from 0 to 21. It’s internal consistency is reported to be good.6
Higher scores indicate worse condition, and the scale was reported to be a valid one.21
GAFsIt is used for treatment plan decision and effect. The scoring is based on global functioning level ranging between 0 and 100, with higher scores indicating better global functioning.6
GICThis is to record the patient’s perception of clinical change. A self-rated 5-point Likert scale is used.20
GPSEIt is a 10-point Likert Scale psychometric measure of self-efficacy to assess optimistic self-beliefs to cope with a variety of difficult demands in life. The GPSE is a commonly used measure and the reliability Cronbach’s alphas range from 0.76 to 0.90.20
IASCIt is a 63-item standardized self-report measure of disturbed function in relation to self or others. It has seven subscales. The number of items per subscale ranges from 5 to 9, each item rated using 1 (never) to 4 (often).14
IES-RIES-R is a 22-item self-report measure using a 5-point Likert scale: 0 to 4 for each item. It is considered a good measure of PTSD symptoms.
IES-R has high level of internal consistency 0.79 to 0.94 and test-retest reliability was between 0.89 and 0.94.19
OQ-45A 45 items self-report measure of overall level of distress. Each item was scored on a 5-point Likert scale, with 0 indicating “never”, and 4 indicating “almost always”. The total score for OQ-45 was 150 with a cut-off of 63. Score ≥ 63 indicated possible clinically significant distress.
OQ-45 has internal consistency ranging from 0.7to 0.93, and test-retest reliability ranging between 0.78 and 0.84.18
PANASIt is a 20 item self-report questionnaire assessing the patient’s positive and negative feelings and emotions on a Likert Scale. The inter-correlations and internal consistency reliabilities are high (ranging from 0.86 to 0.90 for PANAS-P and 0.84 TO 0.87 for PANAS-N. PANAS has been reported to have high scale validity and high item validity.20
PCLIt is a 17 item questionnaire self-report inventory based on PTSD diagnosis. The scale has three sub-scores corresponding to three main syndromes of the disorder: re-experiencing, avoidance, and hyperarousal. The scale has been validated in English and French, and with other anxiety disorder patients.20
PSQIIt measures the quality of sleep which is considered an integral part of an individual’s well-being.20
PSSIt is a 10 item self-report tool that measures the perception of stress of the patient using a Likert Scale. Specific questions relate to unpredictable, uncontrollable and overloaded lives and current levels of stress experienced.20

BDI-II = Beck Depression Inventory - II; CAPS = Clinician Administered PTSD Scale; CES = Combat Exposure Scale; DSM-IV = diagnostic and Statistical Manual of Mental Disorders Fourth edition; DTS = Davidson Trauma Scale; GAD-7 = General Anxiety Disorder Scale; GAFs = Global Assessment Functioning Scale; GIC = Global Impression of Change; GPSE = General Perceived Self-Efficacy Scale; IASC = = Inventory of Altered Self-Capacities; IES-R = Impact of Event Scale-revised; OQ-45 = Outcome Questionnaire - 45; PANAS = Positive and Negative Affect Scale; PCL = PTSD Checklist Scale; PSQI = Pittsburgh Sleep Quality Index; PSS = Perceived Stress Scale; PTSD = post-traumatic stress disorder.

Appendix 3. Critical Appraisal of Included Publications

Table 4Strengths and Limitations of Randomized Controlled Trials using the Downs and Black checklist17

StrengthsLimitations
Randomized Controlled Trials
Caldwell,18 2015, USA
  • The objective was clearly stated
  • The inclusion and exclusion criteria were stated
  • Patient characteristics, intervention and outcomes were described.
  • Randomized study but details of randomization method was not presented
  • P-values were reported
  • Details of randomization were lacking
  • No mention of blinding of patient or assessor
  • Unclear if sample size calculations were undertaken
  • Unclear if there were any withdrawals or lost to follow-up
  • Unclear if ITT analysis was undertaken
  • No mention of conflicts of interest
Dadashi,6 2015, Iran
  • The objective was clearly stated
  • The inclusion and exclusion criteria were stated
  • Patient characteristics, intervention and outcomes were described.
  • Appeared to be a randomized study but there was lack of clarity. The authors mentioned that the patients were randomly assigned to treatment or control groups but also mentioned that the study was a quasi-experimental study.
  • The psychiatrist who did the diagnostic interview at the beginning as well as at the end of the study was blinded.
  • Details of randomization were lacking
  • Unclear if sample size calculations were undertaken
  • Unclear if there were any withdrawals or lost to follow-up
  • Unclear if ITT analysis was undertaken
  • No mention of conflicts of interest
Polak19 2015, The Netherlands
  • The objective was clearly stated
  • The inclusion and exclusion criteria were stated
  • Patient characteristics, intervention and outcomes were described.
  • Randomized study but details of randomization method were not presented
  • In the control (TAU) group one patient missed one session and one patient did not respond to treatment and was lost to follow-up after session 5. In the experimental group (BF+TAU) all patients attended all sessions. The authors mentioned that a mixed model is preferred over repeated measures ANOVA because it can handle missing values and measurements taken at unequal intervals. Hence missing data were not replaced but handled in the mixed model.
  • P-values not always reported
  • Authors mentioned that there were no conflicts of interest
  • Details of randomization were lacking
  • No mention of blinding of patient or assessor
  • Unclear if sample size calculations were undertaken
  • Unclear if ITT analysis was undertaken
van der Kolk,14 2016, USA
  • The objective was clearly stated
  • The inclusion and exclusion criteria were stated
  • Patient characteristics, intervention and outcomes were described.
  • Randomized study but details of randomization method was not presented
  • Dropout rates were reported: 21% in NF treatment group and 8% in control (WL) group.
  • ITT analysis was undertaken. The authors used multilevel Growth Curve Modeling (GCM) and so were able to include the ITT sample without using data imputation procedures. The advantage of using multilevel GCM is that maximum likelihood estimation (MLE) could be used so that patient attrition and missing data did not affect the analyses. Data were screened for patterns of missing data as MLE assumes data are missing at random.
  • 95% confidence intervals were reported
  • Authors mentioned that there were no conflicts of interest
  • Details of randomization were lacking
  • No mention of blinding of patient or assessor
  • Sample size and power analysis indicated that the study was slightly underpowered however statistically significant effects were obtained ruling out type II error
Wahbeh,20 2016, USA
  • The objective was clearly stated
  • The inclusion and exclusion criteria were stated
  • Patient characteristics, intervention and outcomes were described.
  • Randomized study. Covariate adaptive randomization approach was used to ensure groups were well matched on important base line characteristics; further details were not provided.
  • Double-blinding was not feasible. The principle investigator did the data analysis and was blinded to patient allocation.
  • Sample size calculations were conducted and the sample size used was appropriate, even though of the 114 patients randomized. 12 patients withdrew.
  • A completer rather than an ITT analysis was conducted. A mixed model analysis was undertaken which provides valid results in the presence of missing data assuming that the data are missing at random.
  • P-values were reported
  • Not double-blinded
  • There was no mention of conflicts of interest

ITT = intention-to-treat.

Appendix 4. Main Study Findings and Author’s Conclusions

Table 5Summary of Findings of Included Studies

Main Study FindingsAuthor’s Conclusion
Randomized Controlled Trials
Caldwell,182015, USA
Young adults with Major Depression Disorder“HRV biofeedback training appeared to be able to reduce depressed participants’ overall distress and depression level and increase their heart-rate variability. However, we did not find a significant change in their resting-state connectivity. Our findings suggest the need for additional studies on HRV biofeedback training at different stages of depression and how it might affect participants’ neurologically.” (p38)
Treatment groupOutcome measureEffect (mean (SD]) atP value
BaselineFollow-up
HRV-BF + TAUBDI-II24.90 (11.84)12.00 (10.28)< 0.001
OQ-4584.20 (26.02)59.00 (25.21)< 0.001
TAUBDI-II17.70 (7.10)12.10 (5.51)0.239
OQ-4571.10 (19.96)63.20 (14.44)0.610
Dadashi,6 2015, Iran
Adults with GAD

Outcomes with neurofeedback treatment compared to no treatment (waitlist)
“To sum up the results of the current study, it should be mentioned that neurofeedback training in GAD patients cause an increase in alpha and theta brain waves amplitude and such training is effective in reducing GAD symptoms while such changes cannot be observed waiting list group. The results also suggest that on one hand, the utilization of neurofeedback training decreased GAD patients’ symptoms, while on the other hand it increases occupational, social and psychological functioning level in GAD patients.” (p19)
Outcome measureEffect, mean (SD)F statistics, P-value
NFWL
Pre-TxPost-TxPre-TxPost-Tx
GAD-714.67 (3.11)3.67 (1.55)13.25 (2.37)13.33 (2.10)442.72, <0.05
GAFs53.67 (3.11)75.92 (4.16)(4.83)55.42 (4.12)148.88, <0.05
Polak19 2015, The Netherlands
Adults with PTSD

Graphical presentation of PTSD symptom scores (using IES-R scores) overtime (9 weekly sessions and post treatment follow-up) showed that PTSD symptoms decreased over time for both BF + TAU and TAU treatments, but PTSD symptoms decreased faster for with BF + TAU treatment compared with TAU alone (P = 0.051).

The authors conducted a mixed model analysis and included in the model the factors: Time, Intervention, and an interaction between Time and Intervention. The mixed model analysis showed an effect for Time (F = 5.41; df = 8, P < 0.001), a trend for Intervention (F 4.84; df = 1, P =0.061) and a borderline significant interaction for Time x Intervention (F= 2.32; df = 8, P = 0.051).
“In conclusion, our pilot study shows faster clinical improvement in PTSD patients receiving additional attentional breathing biofeedback. Attentional breathing biofeedback has shown a promising adjunctive element for trauma-focused CBT that can be easily implemented in clinical practice and used as a strategy for increasing efficacy of PTSD treatment.” (p30)
van der Kolk,14 2016, USA
Adults with chronic PTSD

Comparison of NF with WL with respect to CAPS scores at various time points
“Compared with the control group NF produced significant PTSD symptom improvement in individuals with chronic PTSD, as well as in affect regulation capacities. NF deserves further investigation for its potential to ameliorate PTSD and to improve affect regulation, and to clarify its mechanisms of action.” (P1)
Analysis typeTreatment or difference in treatmentsCAPS level (mean [95%Cl])Difference in CAPS scorels, (mean [95% Cl])Effect sizea
Pre-TxPost-Tx (immediate)Post-Tx (after 1 month)(Pre-Tx) minus (1-month Post-Tx)(Pre-Tx) minus (1-month Post-Tx)
ITT (N = 52)WL76.24 (69.13, 83.36) N = 2466.49 (57.39, 75.6) N =2265.46 (55.83, 75.1), N = 19−10.78 (−19.1, −2.48)−0.62
NF79.45 (72.86, 86.04), N =2842.95 (34.1, 51.8), N = 2239.1 (29.69, 48.51), N = 19−40.35 (−48.67, −32.12)−2.33
NF - WL3.2 (−6.5, 12.9)−23.54 (−36.24, −10.85)−6.36 (−39.83, −12.9)−29.6 (−41.33, −17.87)−1.71
Completer (N = 44)WL75.18 (67.84, 82.51), N = 2265.68 (56.48, 74.88), N = 2264.68 (54.96, 74.39), N = 19−10.5 (−18.83, −2.19)−0.61
NF80.98 (73.64, 88.31), N = 2244.12 (34.92, 53.31), N = 2240.23 (30.51, 49.95), N = 19−40.75 (−49.11, −32.47)−2.38
NF - WL5.8 (−4.57, 16.17)−21.56 (−34.57, −8.55)−24.45 (−38.19, −10.7)−30.28 (−42.05, −18.51)−1.77
Comparison of NF with WL with respect to DTS scores atvarious time points
Treatment or difference in treatmentsDTS level (mean [95% CI])
Pre-TxMid-TxPost-Tx (immediate)Post-Tx (after 1 month)
WL62.97(52.47, 73.48)60.59 (51.45, 69.74)58.21 (49.26, 67.16)56.62 (47.09, 66.15)
NF67.28 (57.55, 77.00)55.74 (47.25, 64.22)44.19(35.76, 52.63)36.5 (27.4, 45.6)
Score change for (NF - WL)4.30 (−10.01, 18.62)−4.86 (−17.33, 7.62)−14.02 (−26.32, −1.72)−20.12 (−33.3, −6.95)
Effect size for(NF - WL)0.18−0.23−0.66−0.89
Comparison of NF with WL with respect to IASC scores atvarious time points
IASC itemDifference in treatments (NF - WL)DIT level (mean (95%CI])
Pre-TxMid-TxPost-Tx (immediate)Post-Tx (after1 month)
Interpersonal conflictsChange in score−4.27 (−7.53, −1.01)−4.77 (−7.77, −1.77)−5.26 (−8.56, −1.97)−5.59 (−9.34, −1.84)
Effect size−0.76−0.94−0.96−0.90
Tension reduction activitiesChange in score−2.2 (−4.78, 0.39)−4.89 (−7.25, −2.53)−5.74 (−8.34, −3.14)−6.11 (−8.85, −3.37)
Effect size−0.50−1.25−1.35−1.36
Affect dys regulation totalChange in score−2.79 (−6.95, 1.36)−4.63 (−8.21, −1.05)−6.47 (−10.17, −2.77)−7.7 (−11.85, −3.54)
Effect size−0.39−0.76−1.04−1.13
Affect skills deficitChange in score−1.5 (−4.22, 1.22)−2.57 (−4.89, −0.25)−3.64 (−6, −1.28)−4.35 (−6.98, −1.72)
Effect size−0.33−0.65−0.94−1.04
Affect instabilityChange in score−1.3 (−3.29, 0.69)−2.06 (−3.80, −0.31)−2.81 (−4.63, −0.99)−3.32 (−5.35, −1.28)
Effect size−0.38−0.68−0.90−0.97
Identity impairment totalChange in score−1.75 (−6.39, 2.89)−3.15 (−7.31, 1.01)−4.55 (−8.91, −0.19)−5.48 (−10.32, −0.64)
Effect size−0.22−0.44−0.62−0.68
Idealization-disillusionmentChange in score−3.2 (−7.24, 0.84)−4.32 (−8.25, −0.39)−5.44 (−9.73, −1.15)−6.19 (−10.93, −1.45)
Effect size−0.46−0.65−0.75−0.77
Abandonment concernsChange in score−1.26 (−5.68, 3.17)−4.51 (−8.61, −0.40)−5.54 (−10.01, −1.07)−5.99 (−10.68, −1.30)
Effect size−0.17−0.65−0.73−0.76
Susceptibility to influenceChange in score−1.29 (−5.76, 3.17)−2.53 (−6.47, 1.42)−3.76 (−7.7, 0.18)−4.58 (−8.82, −0.35)
Effect size−0.17−0.38−0.56−0.64
Wahbeh,20 2016, USA
Adults (combat veterans) with chronic PTSD

PTSD and related symptoms changes (assessed using PCL)
“Treatment effects were mostly specific to self-report rather than physiological measures. Continued research is needed to further evaluate mindfulness meditation’s mechanism in people with PTSD.” (p365)
InterventionMean (SD)P-value
Pre-treatmentPost-treatment
MM56.3 (9.7)50.7 (3.9)0.05
SB54.5 (11.7)54.2 (12.1)0.59
MMSB52.0 (10.8)46.9 (11.0)0.006
SQ55.3 (9.7)51.5 (12.1)0.04
PTSD and related symptoms changes (assessed using PSS)
InterventionMean(SD)P-value
Pre-treatmentPost-treatment
MM23.4 (4.7)18.7 (5.7)0.0001
SB22.0 (5.8)20.4 (6.8)0.07
MMSB21.4 (7.9)18.9 (6.7)0.05
SQ24.76(5.6)22.2 (5.1)0.03
PTSD and related symptoms changes (assessed using BDI-II)
InterventionMean(SD)P-value
Pre-treatmentPost-treatment
MM21.0 (9.1)14.3 (10.2)0.003
SB23.4 (9.8)22.5 (12.2)0.26
MMSB21.2 (10.1)17.5 (11.3)0.07
SQ22.5 (11.4)20.9 (13.6)0.34
PTSD and related symptoms changes (assessed using PANAS)
MeasureInterventionMean(SD)P-value
Pre-treatmentPost-treatment
PANAS-NMM27.4 (6.0)25.5 (8.0)0.002
SB28.6 (8.4)27.1 (12.7)0.52
MMSB23.7 (8.1)20.3 (7.5)0.05
SQ27.7 (8.4)24.8 (8.0)0.06
PANAS-PMM25.6 (8.0)31.5 (6.6)0.0008
SB25.6 (6.4)29.7 (7.9)0.01
MMSB27.8 (7.1)31.7(4.8)0.04
SQ24.6 (6.5)26.8 (6.8)0.12
PTSD and related symptoms changes (assessed using GPSE)
InterventionMean(SD)P-value
Pre-treatmentPost-treatment
MM27.9 (6.2)30.3 (4.1)0.01
SB28.7 (4.8)28.2 (5.9)0.67
MMSB30.4 (5.3)31.7 (4.9)0.02
SQ28.6 (4.2)28.3 (5.7)0.74
PTSD and related symptoms changes (assessed using PSQI)
InterventionMean(SD)P-value
Pre-treatmentPost-treatment
MM10.7 (4.0)8.4 (4.3)0.0004
SB11.8 (3.9)11.3 (4.0)0.33
MMSB10.1 (3.7)9.5 (3.5)0.43
SQ12.2 (5.2)11.0 (3.9)0.09
Results from mixed model analyses for comparison of MM versus SB versus (MM+SB) versus SQ
Outcome measureSignificant co-variatesModel statistics
PCLCAPS, BDI-IIF(3, 95) = 1.06, P=0.37
PSSCAPS, BDI-IIF(3, 96) = 1.6, P =0.20
BDI-IICAPS, genderF(3, 96) = 1.66, P =0.18
PANAS-NCAPS, BDI-IIF(3, 96)= 2.95, P =0.06
PANAS-PCAPSF(3, 98)= 1.54, P =0.21
GPSECES, BDI-IIF(3, 97)= 1.6, P =0.22
PSQICAPS, adherenceF(3, 96) = 2.43, P =0.07
GICAge, time since event, adherenceF(3, 95)= 3.71, P <0.00005
a

Effect size of 0.2, 0.5, and 0.8 indicates small, medium, and large effect sizes

BDI-II = Beck Depression Inventory - II; BF = Biofeedback; CAPS = Clinician Administered PTSD Scale; CBT = cognitive behavioral therapy; CES = Combat Exposure Scale; CI = confidence interval; DTS = Davidson Trauma Scale; GAD = Generalized Anxiety Disorder; GAD-7 = Generalized Anxiety Disorder Scale; GAFs = Global Assessment Functioning Scale; GIC = global impression of change; GPSE = General Perceived Self-Efficacy Scale; HRV-BF = heart rate variability-BF; IASC = Inventory of Altered Self-Capacities; MM = mindfulness meditation; MMSB = mindful awareness of breadth with the intent to slow breathing; OQ-45 = Outcome Questionnaire - 45; PCL = PTSD Checklist; PANAS = Positive and Negative Affect Scale; PTSD checklist; Post-Tx = post-treatment; Pre-Tx = pre-treatment; PSQI = Pittsburgh Sleep Quality Index; PSS = Perceived Stress Scale; PTSD = post-traumatic stress disorder; SB slow breathing using BF; SD = standard deviation; SQ = sitting quietly; TAU = treatment as usual.

About the Series

CADTH Rapid Response Report: Summary With Critical Appraisal
ISSN: 1922-8147

Version 1.0

Suggested citation:

Neurofeedback and biofeedback for mood and anxiety disorders: a review of clinical effectiveness and guidelines Ottawa: CADTH; 2017 Nov. (CADTH rapid response report: summary with critical appraisal).

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