Psychosocial Group Interventions for Depression

Study Overview
=================
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.

Official Title
-----------------
Psychosocial Group Interventions for Depression: Systemic and Neurophysiological Correlates of Treatment Effect. A Randomized, Controlled Trial

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: CBASP
* Behavioral: Befriending
* Other: Treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBASP<br>Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks). | Behavioral: CBASP<br>* Cognitive behavioral group intervention for individuals suffering from chronic depression<br>Other: Treatment as usual<br>* Conventional psychiatric outpatient treatment (individual counseling)<br>|
| Active Comparator: Befriending<br>Befriending is a social support intervention | Behavioral: CBASP<br>* Cognitive behavioral group intervention for individuals suffering from chronic depression<br>Other: Treatment as usual<br>* Conventional psychiatric outpatient treatment (individual counseling)<br>|
| Active Comparator: Treatment as usual<br>Conventional psychiatric outpatient treatment (individual counseling) | Behavioral: CBASP<br>* Cognitive behavioral group intervention for individuals suffering from chronic depression<br>Behavioral: Befriending<br>* Social support intervention, sessions once per week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Montgomery-Åsberg Depression Rating Scale | At baseline and after intervention (at 5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood biomarkers | Blood samples are collected before and after intervention. | At baseline and after intervention (at 5 mos) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, CBASP, befriending, treatment as usual