Thoughts and Health - Preventing Depression in Adolescents

Depression Clinical Trial

Official title:

Thoughts and Health - Preventing Depression in Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128644
• Other study ID #: 2019-03347
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adolescent Development
• Depression
• Depressive Disorder
• Mental Disorder, Child
• Mental Disorders
• Neurodevelopmental Disorders

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