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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN10647845_PIS_26Oct2016_Finnish.docx Uploaded 26/10/2016