Psychosocial Group Interventions for Depression | NCT02149381

Studies
Psychosocial Group Interventions for Depression

NCT02149381

Sponsor

University of Eastern Finland

Status

Completed

Last Update Posted

Nov 24, 2017Actual

Enrollment

82Actual

Phase

Not Applicable

Conditions

Depression

Interventions

CBASP
Befriending
Treatment as usual

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Apr 7, 2014

First Submission Date that Met QC Criteria

May 26, 2014

First Posted Date

May 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2017

Last Update Posted Date

Nov 24, 2017Actual

Name	Class
Jyväskylä Central Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CBASP	Behavioral	Cognitive behavioral group intervention for individuals suffering from chronic depression	Befriending CBASP Treatment as usual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Soili Lehto, Professor	University of Eastern Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Eastern Finland		Kuopio	Northern Savonia	70211	Finland

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided