PsySysNe: Psychosocial Group Interventions for Depression

• Sponsor: University of Eastern Finland (Other)
• Overall Status: Completed
• CT.gov ID: NCT02149381
• Collaborator: Jyväskylä Central Hospital (Other)
• Enrollment: 82
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: CBASP; Behavioral: Befriending; Other: Treatment as usual	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Psychosocial Group Interventions for Depression: Systemic and Neurophysiological Correlates of Treatment Effect. A Randomized, Controlled Trial
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Depression [At baseline and after intervention (at 5 months)]

   Montgomery-Åsberg Depression Rating Scale

Secondary Outcome Measures

1. Peripheral blood biomarkers [At baseline and after intervention (at 5 mos)]

   Blood samples are collected before and after intervention.

Other Outcome Measures

1. Neurophysiological measurements. [At baseline and after intervention (5 mos)]

   eeg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Eastern Finland	Kuopio	North Savo	Finland	70211

Sponsors and Collaborators

• University of Eastern Finland
• Jyväskylä Central Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Eastern Finland
• ClinicalTrials.gov Identifier: NCT02149381
• Other Study ID Numbers: PsySysNe
• First Posted: May 29, 2014
• Last Update Posted: Nov 24, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by University of Eastern Finland: Depression; treatment as usual; CBASP; befriending
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Nov 24, 2017