Psychosocial Group Interventions for Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: CBASP; Other: Treatment as usual; Behavioral: Befriending

• Registration Number: NCT02149381
• Lead Sponsor: University of Eastern Finland

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.

Detailed Description

The efficacy of 20-week group-CBASP as compared to TAU is evaluated by RCT in a psychiatric outpatient clinics. The recruition is completed.

Study Timeline

• Study First Submitted: 2014-04-07
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-26
• Study First Posted: 2014-05-29
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• 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

Exclusion Criteria

• Psychotic disorder
• Bipolar disorder
• Current substance abuse (excluding nicotine)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	CBASP	Conventional psychiatric outpatient treatment (individual counseling)
CBASP	CBASP	Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).
Befriending	Treatment as usual	Befriending is a social support intervention
CBASP	Treatment as usual	Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).
Befriending	CBASP	Befriending is a social support intervention
Treatment as usual	Befriending	Conventional psychiatric outpatient treatment (individual counseling)

Primary Outcome Measures

Name	Time	Method
Depression	At baseline and after intervention (at 5 months)	Montgomery-Åsberg Depression Rating Scale

Secondary Outcome Measures

Name	Time	Method
Peripheral blood biomarkers	At baseline and after intervention (at 5 mos)	Blood samples are collected before and after intervention.

Trial Locations

Locations (1)

University of Eastern Finland; 🇫🇮 Kuopio, North Savo, Finland