Prevention of Adolescent Major Depression (CWSA-Fin)
Primary Purpose
Depressive Disorder
Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
the Adolescent Coping with Stress
Treatment as usual
usual health education
Sponsored by
About this trial
This is an interventional prevention trial for Depressive Disorder focused on measuring Depressive Disorder, Depressive Disorder, Major, Mental Health, Prevention
Eligibility Criteria
Inclusion Criteria:
- mild to moderate level depressive symptoms (RBDI self-report scale)
- adequate knowledge of the Finnish language
- informed consent from the adolescent (all) and his/her parent (under 15 years)
- healthy controls comprise subjects with no depressive symptoms
Exclusion Criteria:
- ongoing major depression, dysthymia or bipolar disorder
- ongoing other severe psychiatric illness precluding group participation
- mental retardation
Sites / Locations
- Kuopio University Hospital and Kuopio University
- Turku Primary Health care and Adolescent Psychiatric clinic
- Vantaa Primary Health Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Group cognitive intervention (the Adolescent Coping with Stress)
Treatment as usual
Healthy controls, receive usual health education in school health care
Outcomes
Primary Outcome Measures
Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)
Secondary Outcome Measures
Suicidality (diagnostic interview, self-report scale)
Full Information
NCT ID
NCT00611052
First Posted
January 28, 2008
Last Updated
April 19, 2016
Sponsor
Finnish Institute for Health and Welfare
Collaborators
University of Helsinki, University of Eastern Finland, Kuopio University Hospital, City of Vantaa, City of Kuopio, City of Turku
1. Study Identification
Unique Protocol Identification Number
NCT00611052
Brief Title
Prevention of Adolescent Major Depression
Acronym
CWSA-Fin
Official Title
"Adolescents Coping With Stress": Prevention of Adolescent Major Depression in School Health Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Unsuccessful recruitment, failed training of the group leaders leading into lack of study groups
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Finnish Institute for Health and Welfare
Collaborators
University of Helsinki, University of Eastern Finland, Kuopio University Hospital, City of Vantaa, City of Kuopio, City of Turku
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to assess the effect of a cognitive group intervention on prevention of major depression in 14-15-year-old adolescents. Moreover, the effect on other selected mental health parameters are investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Depressive Disorder, Depressive Disorder, Major, Mental Health, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Group cognitive intervention (the Adolescent Coping with Stress)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment as usual
Arm Title
3
Arm Type
Active Comparator
Arm Description
Healthy controls, receive usual health education in school health care
Intervention Type
Behavioral
Intervention Name(s)
the Adolescent Coping with Stress
Intervention Description
A group cognitive intervention, manualized and highly structured. Includes 8 sessions (á 1.5 hours) and a booster session 6 months after termination of the actual intervention. Groups leaders are specifically trained for this course.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care.
Intervention Type
Other
Intervention Name(s)
usual health education
Intervention Description
usual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale
Primary Outcome Measure Information:
Title
Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)
Time Frame
3 months, 6 months, 12months, 24 months, 36 months
Secondary Outcome Measure Information:
Title
Suicidality (diagnostic interview, self-report scale)
Time Frame
3 months, 6 months, 12 months, 24 months, 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild to moderate level depressive symptoms (RBDI self-report scale)
adequate knowledge of the Finnish language
informed consent from the adolescent (all) and his/her parent (under 15 years)
healthy controls comprise subjects with no depressive symptoms
Exclusion Criteria:
ongoing major depression, dysthymia or bipolar disorder
ongoing other severe psychiatric illness precluding group participation
mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauri J Marttunen, Professor
Organizational Affiliation
National Institute for Health nd Welfare, Dept of Mental Health and Substance Abuse Services
Official's Role
Study Director
Facility Information:
Facility Name
Kuopio University Hospital and Kuopio University
City
Kuopio
Country
Finland
Facility Name
Turku Primary Health care and Adolescent Psychiatric clinic
City
Turku
Country
Finland
Facility Name
Vantaa Primary Health Care
City
Vantaa
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Prevention of Adolescent Major Depression
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