Prevention of Adolescent Major Depression - Full Text View

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

MedlinePlus related topics:

Child Mental Health Depression Mental Health Stress

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Single Blind (Investigator), Parallel Assignment

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

Further study details as provided by National Public Health Institute KTL:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Suicidality (diagnostic interview, self-report scale) [ Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.
3: No Intervention 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

Ages Eligible for Study:	14 Years to 16 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611052

Contacts


Contact: Mauri J Marttunen, Professor	+358-40-8334125	mauri.marttunen@ktl.fi

Contact: Linnea M Karlsson, MD, PhD	+358-40-7445052	linnea.karlsson@utu.fi

Locations


Finland
	Turku Primary Health care and Adolescent Psychiatric clinic	Recruiting
	Turku, Finland
	Principal Investigator: Linnea M Karlsson, MD, PhD
	Sub-Investigator: Tanja Martin, MD
	Kuopio University Hospital and Kuopio University	Recruiting
	Kuopio, Finland
	Principal Investigator: Säde Pirttimäki
	Sub-Investigator: Koskinen Tarja, MD
	Vantaa Primary Health Care	Recruiting
	Vantaa, Finland
	Principal Investigator: Maria Vuorilehto, MD
	Sub-Investigator: Melartin Tarja, MD, PhD

Sponsors and Collaborators

National Public Health Institute KTL

Helsinki University

University of Kuopio

Kuopio University Hospital

City of Vantaa

City of Kuopio

City of Turku

Investigators


Study Director:	Mauri J Marttunen, Professor	National Public Health Institute, Dept of Mental Health and Alcohol Research

More Information

Responsible Party:	National Public Health Institute, Dept of Mental Health and Alcohol Research ( Professor Mauri Marttunen )
Study ID Numbers:	KTL423-0
First Received:	January 28, 2008
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00611052
Health Authority:	Finland: Ethics Committee

Keywords provided by National Public Health Institute KTL:

Depressive Disorder

Depressive Disorder, Major

Mental Health

Prevention

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Stress

Depressive Disorder, Major

Depressive Disorder

Behavioral Symptoms

ClinicalTrials.gov processed this record on October 15, 2008

Sponsors and Collaborators:	National Public Health Institute KTL Helsinki University University of Kuopio Kuopio University Hospital City of Vantaa City of Kuopio City of Turku
Information provided by:	National Public Health Institute KTL
ClinicalTrials.gov Identifier:	NCT00611052