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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04128644
Other study ID # 2019-03347
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date January 31, 2025

Study information

Verified date April 2024
Source Vastra Gotaland Region
Contact Josefine Lilja, PhD
Phone +46769402969
Email josefine.lilja@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility 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


Intervention

Behavioral:
Thoughts & health
12 sessions of Thoughts & Health. Baseline questionaires and follow up assessments
Other:
Treatment as Usual
Baseline questionnaires and follow up assessments, intervention as usual, Student Health

Locations

Country Name City State
Sweden FoU Research and Development Göteborg

Sponsors (1)

Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Life quality Collect data from participants through questionnaire: MHC- SF (Mental health continuum), MHC-SF consists of 14 items asking about the frequency of experiences the last month. There are three items on emotional well-being such as feelings of being happy, interested in life and satisfied, five items on social well-being referring to acceptance, actualization, contribution, coherence and integration and six items on psychological well-being capturing purpose in life, environmental mastery, autonomy, personal growth, positive relations and self-acceptance. Answers are given on a 6-point Likert scale from 0-6. 18 month
Other Social adjustment Collect data from participants through questionnaire: EWSAS (Education Work Social Adjustment Scale), EWSAS consists of 5 items asking if and to what amount the mental health issues are affecting friendships, family relationships, school environment and social activities. Likert scale from 0-8. 18 month
Other Mental health Collect data from participants through questionnaire: RCADS (Revised Anxiety and Depression Scale), It is designed to assess clinical syndromes of anxiety as well as depression, building on the DSM-IV criteria. The RCADS provides two total scores, and 6 subscales: Separation Anxiety Disorder (SAD), Social Phobia (SoP), Obsessive Compulsive Disorder (OCD), Panic Disorder (PD), (GAD) and Major Depressive Disorder (MDD). The higher the score the more symptoms of mental health issues. The scale grades from 0-141. 18 month
Other Mental Clinical Assessment Assessment through Clinical interview: MINI-KID (Mini International Neuropsychiatric Interview) 18 month
Primary Depressive episode 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. 18 months
Secondary Complete grades Measures if participants have complete grades from ninth grade when finishing school. Will be collected through public school registers. 18 months
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