Effectiveness of add-on group behavioral activation treatment for depression in psychiatric care

ISRCTN ISRCTN10647845
DOI https://doi.org/10.1186/ISRCTN10647845
Secondary identifying numbers N/A
Submission date
21/10/2016
Registration date
26/10/2016
Last edited
08/05/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Major depressive disorder, often simply called depression, is a mental disorder that causes people to experience low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities. Treatment is often only partly successful, with many patients suffering from persisting symptoms. A combination of different types of treatment is likely to be more effective than a single treatment. The aim of this study is to find out whether adding low-cost group treatments can improve patients’ symptoms.

Who can participate?
Patients aged 18-65 with major depressive disorder

What does the study involve?
Participants are randomly allocated to one of three groups. Participants in the first group receive the usual treatment for depression, which consists of antidepressant medication and psychotherapy (talking therapy). In addition to the usual treatment the second and third groups attend group sessions weekly for 8 weeks. In the second group (peer support), participants discuss their problems helped by a former patient who has recovered from depression. In the third group (behavioral activation), participants analyse their daily activities and are encouraged to participate in meaningful rewarding activities. In all groups, participants’ symptoms are assessed before the first session, 8 weeks later, and at 6 months after the end of the treatment.

What are the possible benefits and risks of participating?
The benefits include access to psychosocial support and possibly an increased chance of recovery. Participants must be willing to discuss their problems in a group of patients.

Where is the study run from?
University of Helsinki and Helsinki University Hospital (Finland)

When is the study starting and how long is it expected to run for?
January 2016 to December 2017

Who is funding the study?
Helsinki and Uusimaa Hospital District (Finland)

Who is the main contact?
Prof. Erkki Isometsä

Contact information

Prof Erkki Isometsä
Scientific

PO Box 22
Helsinki
00014
Finland

ORCiD logoORCID ID 0000-0001-5956-2399

Study information

Study designRandomized three-arm parallel-group study
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN10647845_PIS_26Oct2016_Finnish.docx
Scientific titleEffectiveness of group format behavioral activation treatment for depression or peer support groups added on usual treatment vs treatment as usual for depression in psychiatric care
Study acronymBAPS-D
Study objectives1. Group behavioral activation plus treatment as usual (TAU) is more effective than either peer support plus TAU or TAU alone
2. Peer support plus TAU is more effective than TAU alone
3. Effectiveness of behavioral activation is mediated by patients' adherence to homework, and consequent reduction in experiental avoidance and anhedonia
Ethics approval(s)1. Helsinki and Uusimaa Hospital District ethics committee, 19/05/2016, ref: 178/13/03/03/2016
2. Department of Psychiatry, Helsinki University Hospital, 26/08/2016, ref: HUS/242/2016
Health condition(s) or problem(s) studiedMajor depressive disorder
InterventionParticipants are randomised to one of three treatments:
1. Treatment as usual, plus behavioral activation treatment for depression (BATD) in group format weekly for 8 weeks at the premises of the outpatient clinic. The sessions last 90 minutes and are delivered by two therapists who are experienced mental health professionals (mostly psychiatric nurses or psychologists).
2. Treatment as usual, plus group peer support weekly for 8 weeks, in which a group of patients regularly meet to discuss their problems at the premises of the outpatient clinic, facilitated by an expert by experience having recovered from depression and received brief training for the task by Finnish Central Association for Mental Health. The sessions last 90 minutes, and one psychiatric nurse participates in the session, but does not have an active facilitator role.
3. Treatment as usual, mostly comprising antidepressant pharmacotherapy and low-intensity psychotherapeutic support provided by a specialized nurse. Number of visits not predefined.

In all groups, symptoms are evaluated before the first session or visit after randomization in the TAU group, and 8 weeks later (primary outcome 8-week PHQ-9). Six months after the end of intervention, there is a follow-up measurement using the PHQ-9 (one of the secondary outcomes).
Intervention typeBehavioural
Primary outcome measureDepression score, measured using the Patient Health Questionnaire (PHQ-9) at baseline and after the 8-week intervention
Secondary outcome measures1. Response, defined as ≥ 50% decline in PHQ-9 score, measured at 8 weeks
2. Remission, defined as PHQ-9 score < 5, measured at 8 weeks
3. Functional impairment, measured using the Sheehan Disability Scale Score at baseline and 8 weeks
4. Depression score, measured using the PHQ-9 at baseline and 6 months after the intervention
Overall study start date18/01/2016
Completion date31/12/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants288
Total final enrolment140
Key inclusion criteria1. Psychiatric outpatient at the Helsinki University Hospital Department of Psychiatry Mood Disorder Division
2. DSM-5 major depressive disorder
3. Fluency in Finnish
4. Age 18-65 years
Key exclusion criteria1. Psychotic features
2. Chronic major depressive disorder (uninterrupted duration > 2 years)
3. Principal clinical diagnosis borderline personality disorder
4. Principal clinical diagnosis substance use disorder
5. Imminent threat of suicide
6. Need of psychiatric hospitalization
7. Any illness or symptom hampering participation in the treatments
8. Other ongoing weekly psychotherapy
Date of first enrolment07/09/2016
Date of final enrolment30/04/2017

Locations

Countries of recruitment

  • Finland

Study participating centre

Department of Psychiatry, University of Helsinki and Helsinki University Hospital
PO Box 22
Helsinki
00014
Finland

Sponsor information

University of Helsinki and Helsinki University Hospital
University/education

PO Box 22
Helsinki
00014
Finland

ROR logo "ROR" https://ror.org/02e8hzf44

Funders

Funder type

Hospital/treatment centre

Helsinki and Uusimaa Hospital District

No information available

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planTo be published as scientific articles in international journals as soon as possible after the trial has been completed and analysed.
IPD sharing planParticipant level data not available due to constraints of the Finnish data protection legislation and ethical and research permissions.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 26/10/2016 26/10/2016 No Yes
Results article 30/04/2024 08/05/2024 Yes No

Additional files

ISRCTN10647845_PIS_26Oct2016_Finnish.docx
Uploaded 26/10/2016

Editorial Notes

08/05/2024: Publication reference and total final enrolment added.