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Prevention of Adolescent Major Depression (CWSA-Fin)

This study has been terminated.
(Unsuccessful recruitment, failed training of the group leaders leading into lack of study groups)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00611052
First Posted: February 8, 2008
Last Update Posted: April 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Helsinki University
University of Eastern Finland
Kuopio University Hospital
City of Vantaa
City of Kuopio
City of Turku
Information provided by (Responsible Party):
Linnea Karlsson, National Institute for Health and Welfare, Finland
  Purpose
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.

Condition Intervention
Depressive Disorder Behavioral: the Adolescent Coping with Stress Behavioral: Treatment as usual Other: usual health education

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: "Adolescents Coping With Stress": Prevention of Adolescent Major Depression in School Health Care

Further study details as provided by Linnea Karlsson, National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • 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 Measures:
  • Suicidality (diagnostic interview, self-report scale) [ Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months ]

Enrollment: 65
Study Start Date: March 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Group cognitive intervention (the Adolescent Coping with Stress)
Behavioral: the Adolescent Coping with Stress
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.
Active Comparator: 2
Treatment as usual
Behavioral: Treatment as usual
The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care.
Active Comparator: 3
Healthy controls, receive usual health education in school health care
Other: usual health education
usual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT00611052


Locations
Finland
Kuopio University Hospital and Kuopio University
Kuopio, Finland
Turku Primary Health care and Adolescent Psychiatric clinic
Turku, Finland
Vantaa Primary Health Care
Vantaa, Finland
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Helsinki University
University of Eastern Finland
Kuopio University Hospital
City of Vantaa
City of Kuopio
City of Turku
Investigators
Study Director: Mauri J Marttunen, Professor National Institute for Health nd Welfare, Dept of Mental Health and Substance Abuse Services
  More Information

Responsible Party: Linnea Karlsson, senior researcher, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT00611052     History of Changes
Other Study ID Numbers: KTL423-0
First Submitted: January 28, 2008
First Posted: February 8, 2008
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Linnea Karlsson, National Institute for Health and Welfare, Finland:
Depressive Disorder
Depressive Disorder, Major
Mental Health
Prevention

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