Psychosocial Group Interventions for Depression

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02149381

Acronym

PsySysNe

Enrollment

Registered

2014-05-29

Start date

2014-05-31

Completion date

2016-05-31

Last updated

2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, treatment as usual, CBASP, befriending

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.

Interventions

BEHAVIORALCBASP

Cognitive behavioral group intervention for individuals suffering from chronic depression

BEHAVIORALBefriending

Social support intervention, sessions once per week

OTHERTreatment as usual

Conventional psychiatric outpatient treatment (individual counseling)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026