MedDataX Logo

Psychosocial Group Interventions for Depression

NCT ID: NCT02149381

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Depression treatment as usual CBASP befriending

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBASP

Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).

Group Type EXPERIMENTAL

CBASP

Intervention Type BEHAVIORAL

Cognitive behavioral group intervention for individuals suffering from chronic depression

Treatment as usual

Intervention Type OTHER

Conventional psychiatric outpatient treatment (individual counseling)

Befriending

Befriending is a social support intervention

Group Type ACTIVE_COMPARATOR

CBASP

Intervention Type BEHAVIORAL

Cognitive behavioral group intervention for individuals suffering from chronic depression

Treatment as usual

Intervention Type OTHER

Conventional psychiatric outpatient treatment (individual counseling)

Treatment as usual

Conventional psychiatric outpatient treatment (individual counseling)

Group Type ACTIVE_COMPARATOR

CBASP

Intervention Type BEHAVIORAL

Cognitive behavioral group intervention for individuals suffering from chronic depression

Befriending

Intervention Type BEHAVIORAL

Social support intervention, sessions once per week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBASP

Cognitive behavioral group intervention for individuals suffering from chronic depression

Intervention Type BEHAVIORAL

Befriending

Social support intervention, sessions once per week

Intervention Type BEHAVIORAL

Treatment as usual

Conventional psychiatric outpatient treatment (individual counseling)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jyväskylä Central Hospital

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Soili Lehto, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Eastern Finland

Kuopio, Northern Savonia, Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PsySysNe

Identifier Type: -

Identifier Source: org_study_id