Thoughts and Health - Preventing Depression in Adolescents

NCT ID: NCT04128644

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Adolescent Development Mental Disorder, Child

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of care+Thoughts & health

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

Group Type OTHER

Thoughts & health

Intervention Type BEHAVIORAL

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

Treatment as Usual

Intervention Type OTHER

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

Standard of care

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

Group Type OTHER

Treatment as Usual

Intervention Type OTHER

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

Interventions

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Thoughts & health

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

Intervention Type BEHAVIORAL

Treatment as Usual

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josefine Lilja, PhD

Role: PRINCIPAL_INVESTIGATOR

Vastra Gotaland Region

Locations

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FoU Research and Development

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Josefine Lilja, PhD

Role: CONTACT

+46769402969

Carl Wikberg, PhD

Role: CONTACT

+46703821660

Facility Contacts

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Carl Wikberg

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33483440 (View on PubMed)

Other Identifiers

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2019-03347

Identifier Type: -

Identifier Source: org_study_id

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