Psychosocial Group Interventions for Depression

Depression Clinical Trial

— PsySysNe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149381
• Other study ID #: PsySysNe
• Status: Completed
• Phase: N/A
• First received: April 7, 2014
• Last updated: November 22, 2017
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2017
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• CBASP
Cognitive behavioral group intervention for individuals suffering from chronic depression
• Befriending
Social support intervention, sessions once per week

Other:
• Treatment as usual
Conventional psychiatric outpatient treatment (individual counseling)

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio	North Savo

Sponsors (2)

Lead Sponsor	Collaborator
University of Eastern Finland	Jyväskylä Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurophysiological measurements.	eeg	At baseline and after intervention (5 mos)
Primary	Depression	Montgomery-Åsberg Depression Rating Scale	At baseline and after intervention (at 5 months)
Secondary	Peripheral blood biomarkers	Blood samples are collected before and after intervention.	At baseline and after intervention (at 5 mos)