Psychosocial Group Interventions for Depression
PsySysNe
1 other identifier
interventional
82
1 country
1
Brief Summary
A total of 384 patients suffering from chronic depressive disorder will be randomized to receive treatment as usual, CBASP, or befriending for a period of five months. The primary outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and neurophysiological parameters. The data gathering is performed at pre- and post intervention stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the participants six months after the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedNovember 24, 2017
November 1, 2017
2 years
April 7, 2014
November 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression
Montgomery-Åsberg Depression Rating Scale
At baseline and after intervention (at 5 months)
Secondary Outcomes (1)
Peripheral blood biomarkers
At baseline and after intervention (at 5 mos)
Other Outcomes (1)
Neurophysiological measurements.
At baseline and after intervention (5 mos)
Study Arms (3)
CBASP
EXPERIMENTALCognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).
Befriending
ACTIVE COMPARATORBefriending is a social support intervention
Treatment as usual
ACTIVE COMPARATORConventional psychiatric outpatient treatment (individual counseling)
Interventions
Cognitive behavioral group intervention for individuals suffering from chronic depression
Conventional psychiatric outpatient treatment (individual counseling)
Eligibility Criteria
You may qualify if:
- Age 18-65
- Moderate or severe major depression with duration of a minimum of two years OR "double depression" (dysthymia and moderate/severe major depression simultaneously) OR moderate or severe major depression with duration of a minimum of two years, only partially remitted during the time period
You may not qualify if:
- Psychotic disorder
- Bipolar disorder
- Current substance abuse (excluding nicotine)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Eastern Finlandlead
- Jyväskylä Central Hospitalcollaborator
Study Sites (1)
University of Eastern Finland
Kuopio, Northern Savonia, 70211, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soili Lehto, Professor
University of Eastern Finland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2014
First Posted
May 29, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
November 24, 2017
Record last verified: 2017-11