Prevention of Adolescent Major Depression

Depressive Disorder Clinical Trial

— CWSA-Fin  

Official title:

"Adolescents Coping With Stress": Prevention of Adolescent Major Depression in School Health Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00611052
• Other study ID #: KTL423-0
• Status: Terminated
• Phase: N/A
• First received: January 28, 2008
• Last updated: April 19, 2016
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 16 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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.
• Treatment as usual
The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms 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

Locations

Country	Name	City	State
Finland	Kuopio University Hospital and Kuopio University	Kuopio
Finland	Turku Primary Health care and Adolescent Psychiatric clinic	Turku
Finland	Vantaa Primary Health Care	Vantaa

Sponsors (7)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	City of Kuopio, City of Turku, City of Vantaa, Helsinki University, Kuopio University Hospital, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)		3 months, 6 months, 12months, 24 months, 36 months	Yes
Secondary	Suicidality (diagnostic interview, self-report scale)		3 months, 6 months, 12 months, 24 months, 36 months	Yes