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Thoughts and Health - Preventing Depression in Adolescents

Primary Purpose

Depression, Adolescent Development, Mental Disorder, Child

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Thoughts & health
Treatment as Usual
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring depression, prevention, school

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FoU Research and DevelopmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Standard of care+Thoughts & health

Standard of care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2019
Last Updated
April 25, 2023
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT04128644
Brief Title
Thoughts and Health - Preventing Depression in Adolescents
Official Title
Thoughts and Health - Preventing Depression in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Adolescent Development, Mental Disorder, Child
Keywords
depression, prevention, school

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care+Thoughts & health
Arm Type
Other
Arm Description
12 sessions of Thoughts & Health. Baseline questionnaires and follow up assessments
Arm Title
Standard of care
Arm Type
Other
Arm Description
Baseline questionnaires and follow up assessments, intervention as usual Student Health
Intervention Type
Behavioral
Intervention Name(s)
Thoughts & health
Intervention Description
12 sessions of Thoughts & Health. Baseline questionaires and follow up assessments
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Baseline questionnaires and follow up assessments, intervention as usual, Student Health
Primary Outcome Measure Information:
Title
Depressive episode
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Complete grades
Description
Measures if participants have complete grades from ninth grade when finishing school. Will be collected through public school registers.
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Life quality
Description
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.
Time Frame
18 month
Title
Social adjustment
Description
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.
Time Frame
18 month
Title
Mental health
Description
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.
Time Frame
18 month
Title
Mental Clinical Assessment
Description
Assessment through Clinical interview: MINI-KID (Mini International Neuropsychiatric Interview)
Time Frame
18 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josefine Lilja, PhD
Phone
+46769402969
Email
josefine.lilja@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Carl Wikberg, PhD
Phone
+46703821660
Email
carl.wikberg@allmed.gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josefine Lilja, PhD
Organizational Affiliation
Vastra Gotaland Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
FoU Research and Development
City
Göteborg
ZIP/Postal Code
41119
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Wikberg
Email
carl.wikberg@allmed.gu.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33483440
Citation
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.
Results Reference
derived

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Thoughts and Health - Preventing Depression in Adolescents

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