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Completed

NCT Number: NCT04128644

Thoughts and Health - Preventing Depression in Adolescents

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FoU Research and Development

Gothenburg, 41119, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoughts & health

Behavioral

12 sessions of Thoughts & Health. Baseline questionaires and follow up assessments

Treatment as Usual

Other

Baseline questionnaires and follow up assessments, intervention as usual, Student Health

Primary outcomes

  1. Depressive episode

    Time frame: 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 outcomes

  1. Complete grades

    Time frame: 18 months

    Measures if participants have complete grades from ninth grade when finishing school. Will be collected through public school registers.

Other outcomes

  1. Life quality

    Time frame: 18 month

    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.

  2. Social adjustment

    Time frame: 18 month

    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.

  3. Mental health

    Time frame: 18 month

    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.

  4. Mental Clinical Assessment

    Time frame: 18 month

    Assessment through Clinical interview: MINI-KID (Mini International Neuropsychiatric Interview)

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2019
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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