Thoughts and Health - Preventing Depression in Adolescents
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Nov 2019
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 16, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedApril 25, 2024
April 1, 2024
5.3 years
October 3, 2019
April 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Complete grades
18 months
Other Outcomes (4)
Life quality
18 month
Social adjustment
18 month
Mental health
18 month
- +1 more other outcomes
Study Arms (2)
Standard of care+Thoughts & health
OTHER12 sessions of Thoughts \& Health. Baseline questionnaires and follow up assessments
Standard of care
OTHERBaseline questionnaires and follow up assessments, intervention as usual Student Health
Interventions
12 sessions of Thoughts \& Health. Baseline questionaires and follow up assessments
Baseline questionnaires and follow up assessments, intervention as usual, Student Health
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current or past depression
- Unable to function in a group session
- Current psychotherapeutic treatment
- Past or current suicidal thoughts or attempts
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
FoU Research and Development
Gothenburg, 41119, Sweden
Related Publications (1)
Wikberg C, Augustsson P, Sveinsdottir G, Craighead WE, Arnarson EO, Marteinsdottir I, Lilja JL. Is the Thoughts and Health programme feasible in the context of Swedish schools? A quasi-experimental controlled trial study protocol. BMJ Open. 2021 Jan 22;11(1):e040374. doi: 10.1136/bmjopen-2020-040374.
PMID: 33483440DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josefine Lilja, PhD
Vastra Gotaland Region
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 16, 2019
Study Start
November 1, 2019
Primary Completion
January 31, 2025
Study Completion
January 31, 2025
Last Updated
April 25, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- After publication of long term follow up (18month follow up) and then no end date.
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.