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OpenTrials
Completed

NCT Number: NCT02149381

Psychosocial Group Interventions for Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland

Kuopio, Northern Savonia, 70211, Finland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CBASP

Behavioral

Cognitive behavioral group intervention for individuals suffering from chronic depression

Befriending

Behavioral

Social support intervention, sessions once per week

Treatment as Usual

Other

Conventional psychiatric outpatient treatment (individual counseling)

Primary outcomes

  1. Depression

    Time frame: At baseline and after intervention (at 5 months)

    Montgomery-Åsberg Depression Rating Scale

Secondary outcomes

  1. Peripheral blood biomarkers

    Time frame: At baseline and after intervention (at 5 mos)

    Blood samples are collected before and after intervention.

Other outcomes

  1. Neurophysiological measurements.

    Time frame: At baseline and after intervention (5 mos)

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Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • Jyväskylä Central Hospital

Registry information

Official study title

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

Acronym: PsySysNe

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 29, 2014
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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