Psychosocial Group Interventions for Depression (PsySysNe)

November 22, 2017 updated by: University of Eastern Finland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • North Savo
      • Kuopio, North Savo, Finland, 70211
        • University of Eastern Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: At baseline and after intervention (at 5 months)
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
Time Frame: At baseline and after intervention (at 5 mos)
Blood samples are collected before and after intervention.
At baseline and after intervention (at 5 mos)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurophysiological measurements.
Time Frame: At baseline and after intervention (5 mos)
eeg
At baseline and after intervention (5 mos)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Eastern Finland

Collaborators

Jyväskylä Central Hospital

Investigators

  • Principal Investigator: Soili Lehto, Professor, University of Eastern Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

May 26, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PsySysNe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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