Back to resultsPsychosocial Group Interventions for Depression (PsySysNe)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
CBASP
Befriending
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, treatment as usual, CBASP, befriending
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)
Sites / Locations
- University of Eastern Finland
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
CBASP
Befriending
Treatment as usual
Arm Description
Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).
Befriending is a social support intervention
Conventional psychiatric outpatient treatment (individual counseling)
Outcomes
Primary Outcome Measures
Depression
Montgomery-Åsberg Depression Rating Scale
Secondary Outcome Measures
Peripheral blood biomarkers
Blood samples are collected before and after intervention.
Full Information
NCT ID
NCT02149381
First Posted
April 7, 2014
Last Updated
November 22, 2017
Sponsor
University of Eastern Finland
Collaborators
Jyväskylä Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02149381
Brief Title
Psychosocial Group Interventions for Depression
Acronym
PsySysNe
Official Title
Psychosocial Group Interventions for Depression: Systemic and Neurophysiological Correlates of Treatment Effect. A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Eastern Finland
Collaborators
Jyväskylä Central Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, treatment as usual, CBASP, befriending
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBASP
Arm Type
Experimental
Arm Description
Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).
Arm Title
Befriending
Arm Type
Active Comparator
Arm Description
Befriending is a social support intervention
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Conventional psychiatric outpatient treatment (individual counseling)
Intervention Type
Behavioral
Intervention Name(s)
CBASP
Intervention Description
Cognitive behavioral group intervention for individuals suffering from chronic depression
Intervention Type
Behavioral
Intervention Name(s)
Befriending
Intervention Description
Social support intervention, sessions once per week
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Conventional psychiatric outpatient treatment (individual counseling)
Primary Outcome Measure Information:
Title
Depression
Description
Montgomery-Åsberg Depression Rating Scale
Time Frame
At baseline and after intervention (at 5 months)
Secondary Outcome Measure Information:
Title
Peripheral blood biomarkers
Description
Blood samples are collected before and after intervention.
Time Frame
At baseline and after intervention (at 5 mos)
Other Pre-specified Outcome Measures:
Title
Neurophysiological measurements.
Description
eeg
Time Frame
At baseline and after intervention (5 mos)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soili Lehto, Professor
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
State/Province
North Savo
ZIP/Postal Code
70211
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Psychosocial Group Interventions for Depression
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