Thoughts and Health - Preventing Depression in Adolescents

Not Applicable

Recruiting

• Conditions: Depression; Adolescent Development; Mental Disorder, Child
• Interventions: Behavioral: Thoughts & health; Other: Treatment as Usual

• Registration Number: NCT04128644
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

This study aims to test the feasibility of implementing an Icelandic cognitive-behavioral program designed to prevent depression, called "Thoughts and Health" in a Swedish school setting. The investigators will also evaluate whether implementation of the program has an impact on the participating students, regarding both their mental health and their success in finishing junior high school with passing grades.

Detailed Description

Clinical depression is a crucial problem among adolescents. In eighth grade more than half of all students experience headaches, stomach pain, stress, feeling down, and difficulties sleeping. Adolescents affected by depression at a young age are at greater risk of experiencing depressive symptoms as adults, with serious impacts on their quality of life and ability to work. Recent reports from the National Board of Health and Welfare have shown that depression is increasing among adolescents and there is now focus on implementing practice-oriented preventative programs for youth.

Studies by members of our research team have shown that a cognitive-behavioral, developmentally-based intervention program, called "Thoughts and Health", prevented initial episodes of depression and/or dysthymia in adolescents for up to 12 months after program completion.

This study aims to test the feasibility of implementing that program in a Swedish school setting, while also collecting and analyzing preliminary results regarding the potential impact of the program on number of students developing depressive symptoms and the number passing junior high school with full grades.

This is an intervention study with a control group. Students from two Swedish junior high schools will be identified as "at-risk" and invited to participate in the program (n=40), while students from two other schools will act as controls (n=40). All participating students will be followed from study start (baseline) and 1, 6, 12, and 18 months after program completion. Results will include quantitative clinical measures, qualitative focus group discussions, and students' final grades. Two courses of the program will be run over two school years. This study involves close collaboration between academia, primary care, and the community.

This is to our knowledge the first study in Sweden that employs a longitudinal design to evaluate the effects of a school program aimed at preventing depression in adolescents.

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-16
• Study Start: 2019-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Eight grader (school)
• Completed Childrens Depression Inventory (CDI) screening
• Able to understand Swedish both orally and written to a level that he/she can complete forms and questionnaires by themselves

Exclusion Criteria

• Current or past depression
• Unable to function in a group session
• Current psychotherapeutic treatment
• Past or current suicidal thoughts or attempts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care+Thoughts & health	Thoughts & health	12 sessions of Thoughts \& Health. Baseline questionnaires and follow up assessments
Standard of care+Thoughts & health	Treatment as Usual	12 sessions of Thoughts \& Health. Baseline questionnaires and follow up assessments
Standard of care	Treatment as Usual	Baseline questionnaires and follow up assessments, intervention as usual Student Health

Primary Outcome Measures

Name	Time	Method
Depressive episode	18 months	Number of participants that have scores that indicate a depressive episode. Questionnaire CDI (Children Depression Inventory), CDI has 27 items scores, each item range from 0-3, above the 90th percentile indicate depressive problems, 90th percentile indicate depressive episode.

Secondary Outcome Measures

Name	Time	Method
Complete grades	18 months	Measures if participants have complete grades from ninth grade when finishing school. Will be collected through public school registers.

Trial Locations

Locations (1)

FoU Research and Development; 🇸🇪 Göteborg, Sweden