Thoughts and Health - Preventing Depression in Adolescents

April 25, 2023 updated by: Vastra Gotaland Region
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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard of care+Thoughts & health
12 sessions of Thoughts & Health. Baseline questionnaires and follow up assessments
12 sessions of Thoughts & Health. Baseline questionaires and follow up assessments
Baseline questionnaires and follow up assessments, intervention as usual, Student Health
Other: Standard of care
Baseline questionnaires and follow up assessments, intervention as usual Student Health
Baseline questionnaires and follow up assessments, intervention as usual, Student Health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 month
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.
18 month
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.
18 month
Mental Clinical Assessment
Time Frame: 18 month
Assessment through Clinical interview: MINI-KID (Mini International Neuropsychiatric Interview)
18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Josefine Lilja, PhD, Vastra Gotaland Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

January 31, 2025

Study Completion (Anticipated)

January 31, 2025

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Immediately following publication, individual participant data that underlie the result, after de-identification (text, tables, figures, and appendices) will be available. Researchers that provide a sound and methodological proposal will gain access to achieve aims in the approved proposal. Proposals should be directed to josefine.lilja@vgregion.se To gain access, data requestor s will need to sign a data access agreement.

IPD Sharing Time Frame

After publication of long term follow up (18month follow up) and then no end date.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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