- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02149381
Psychosocial Group Interventions for Depression (PsySysNe)
November 22, 2017 updated by: University of Eastern Finland
Psychosocial Group Interventions for Depression: Systemic and Neurophysiological Correlates of Treatment Effect. A Randomized, Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Savo
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Kuopio, North Savo, Finland, 70211
- University of Eastern Finland
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBASP
Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).
|
Cognitive behavioral group intervention for individuals suffering from chronic depression
Conventional psychiatric outpatient treatment (individual counseling)
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Active Comparator: Befriending
Befriending is a social support intervention
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Cognitive behavioral group intervention for individuals suffering from chronic depression
Conventional psychiatric outpatient treatment (individual counseling)
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Active Comparator: Treatment as usual
Conventional psychiatric outpatient treatment (individual counseling)
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Cognitive behavioral group intervention for individuals suffering from chronic depression
Social support intervention, sessions once per week
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: At baseline and after intervention (at 5 months)
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Montgomery-Åsberg Depression Rating Scale
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At baseline and after intervention (at 5 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral blood biomarkers
Time Frame: At baseline and after intervention (at 5 mos)
|
Blood samples are collected before and after intervention.
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At baseline and after intervention (at 5 mos)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurophysiological measurements.
Time Frame: At baseline and after intervention (5 mos)
|
eeg
|
At baseline and after intervention (5 mos)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Soili Lehto, Professor, University of Eastern Finland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
April 7, 2014
First Submitted That Met QC Criteria
May 26, 2014
First Posted (Estimate)
May 29, 2014
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 22, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PsySysNe
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on CBASP
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University of EdinburghCompleted
-
University of EdinburghUnknown
-
Philipps University Marburg Medical CenterUniversität Duisburg-EssenCompleted
-
University of VirginiaCompletedDepressive Disorder | Alcoholism | Alcohol-Related Disorders | Major Depressive Disorder | Dysthymic DisorderUnited States
-
University of GreifswaldGerman Research Foundation; Charite University, Berlin, Germany; Hannover Medical... and other collaboratorsRecruitingTreatment-resistant Depression | Persistent Depressive DisorderGermany
-
Weill Medical College of Cornell UniversityNational Institute of Mental Health (NIMH)CompletedDepressive Disorder | DepressionUnited States
-
University Hospital FreiburgUniversity Hospital, BonnUnknownChronic DepressionGermany
-
M.D. Anderson Cancer CenterNational Institute of Mental Health (NIMH)Active, not recruiting