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Psychosocial Group Interventions for Depression (PsySysNe)

U

University of Eastern Finland

Status

Completed

Conditions

Depression

Treatments

Other: Treatment as usual
Behavioral: Befriending
Behavioral: CBASP

Study type

Interventional

Funder types

Other

Identifiers

NCT02149381
PsySysNe

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 3 patient groups

CBASP
Experimental group
Description:
Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).
Treatment:
Other: Treatment as usual
Behavioral: CBASP
Befriending
Active Comparator group
Description:
Befriending is a social support intervention
Treatment:
Other: Treatment as usual
Behavioral: CBASP
Treatment as usual
Active Comparator group
Description:
Conventional psychiatric outpatient treatment (individual counseling)
Treatment:
Behavioral: Befriending
Behavioral: CBASP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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