Condition category
Mental and Behavioural Disorders
Date applied
21/10/2016
Date assigned
26/10/2016
Last edited
26/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Erkki Isometsä

ORCID ID

http://orcid.org/0000-0001-5956-2399

Contact details

PO Box 22
Helsinki
00014
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness 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

Acronym

BAPS-D

Study hypothesis

1. 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

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

Study design

Randomized three-arm parallel-group study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Major depressive disorder

Intervention

Participants 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 type

Behavioural

Phase

Drug names

Primary outcome measures

Depression score, measured using the Patient Health Questionnaire (PHQ-9) at baseline and after the 8-week intervention

Secondary outcome measures

1. 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 trial start date

18/01/2016

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

288

Participant exclusion criteria

1. 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

Recruitment start date

07/09/2016

Recruitment end date

30/04/2017

Locations

Countries of recruitment

Finland

Trial participating centre

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

Sponsor information

Organisation

University of Helsinki and Helsinki University Hospital

Sponsor details

PO Box 22
Helsinki
00014
Finland

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Helsinki and Uusimaa Hospital District

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be published as scientific articles in international journals as soon as possible after the trial has been completed and analysed.

IPD sharing plan
Participant level data not available due to constraints of the Finnish data protection legislation and ethical and research permissions.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes