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Psychosocial Group Interventions for Depression (PsySysNe)

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ClinicalTrials.gov Identifier: NCT02149381
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Jyväskylä Central Hospital
Information provided by (Responsible Party):
University of Eastern Finland

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 Not Applicable

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  (Clinical Trial)
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 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Depression [ Time Frame: At baseline and after intervention (at 5 months) ]
    Montgomery-Åsberg Depression Rating Scale


Secondary Outcome Measures :
  1. Peripheral blood biomarkers [ Time Frame: At baseline and after intervention (at 5 mos) ]
    Blood samples are collected before and after intervention.


Other Outcome Measures:
  1. Neurophysiological measurements. [ Time Frame: At baseline and after intervention (5 mos) ]
    eeg



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149381


Locations
Finland
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

Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT02149381     History of Changes
Other Study ID Numbers: PsySysNe
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by University of Eastern Finland:
Depression
treatment as usual
CBASP
befriending

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders