Prevention of Adolescent Major Depression

NCT00611052 | Terminated

• 1 other identifier: KTL423-0
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

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.

Conditions

Depressive Disorder

Keywords

Depressive Disorder; Depressive Disorder, Major; Mental Health; Prevention

Outcome Measures

Primary Outcomes (1)

• Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)

  3 months, 6 months, 12months, 24 months, 36 months

Secondary Outcomes (1)

• Suicidality (diagnostic interview, self-report scale)

  3 months, 6 months, 12 months, 24 months, 36 months

Study Arms (3)

1

EXPERIMENTAL

Group cognitive intervention (the Adolescent Coping with Stress)

Behavioral: the Adolescent Coping with Stress

2

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Treatment as usual

3

ACTIVE COMPARATOR

Healthy controls, receive usual health education in school health care

Other: usual health education

Interventions

the Adolescent Coping with Stress BEHAVIORAL

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.

1

Treatment as usual BEHAVIORAL

The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care.

2

usual health education OTHER

usual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale

3

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• ongoing major depression, dysthymia or bipolar disorder
• ongoing other severe psychiatric illness precluding group participation
• mental retardation

Sponsors & Collaborators

• Finnish Institute for Health and Welfare: lead
• University of Helsinki: collaborator
• University of Eastern Finland: collaborator
• Kuopio University Hospital: collaborator
• City of Vantaa: collaborator
• City of Kuopio: collaborator
• City of Turku: collaborator

Study Sites (3)

Kuopio University Hospital and Kuopio University

Kuopio, Finland

Location

Turku Primary Health care and Adolescent Psychiatric clinic

Turku, Finland

Location

Vantaa Primary Health Care

Vantaa, Finland

Location

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major; Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Mauri J Marttunen, Professor

  National Institute for Health nd Welfare, Dept of Mental Health and Substance Abuse Services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior researcher

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

FI (3)