DepressionNCT04128644
Thoughts and Health - Preventing Depression in Adolescents
A study testing Thoughts & health and Treatment as Usual in people with Depression and Adolescent Development, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Depression, Adolescent Development, Mental Disorder, Child
- What is being tested?
- Thoughts & health and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2019to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Current or past depression
- Unable to function in a group session
- Current psychotherapeutic treatment
- Past or current suicidal thoughts or attempts
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression, Adolescent Development, Mental Disorder, Child
- Being tested
- Thoughts & health, Treatment as Usual
- Keywords
- depression, prevention, school
- Medical subject headings
- Depression, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoughts & healthBehavioural
12 sessions of Thoughts \& Health. Baseline questionaires and follow up assessments
Treatment as UsualOther
Baseline questionnaires and follow up assessments, intervention as usual, Student Health
| Study group | Role | What they receive |
|---|---|---|
| Standard of care+Thoughts & health | Other | 12 sessions of Thoughts \& Health. Baseline questionnaires and follow up assessments Receives: Behavioral: Thoughts & health; Other: Treatment as Usual |
| Standard of care | Other | Baseline questionnaires and follow up assessments, intervention as usual Student Health Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
Complete grades
Measures if participants have complete grades from ninth grade when finishing school. Will be collected through public school registers.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Nov 2019
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Josefine Lilja, PhD, Principal investigator, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128644
- Sponsor's protocol ID
- 2019-03347
- Other IDs
- 2019
- Status last verified
- Oct 2025
- First submitted
- 3 Oct 2019
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33483440
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoughts and Health - Preventing Depression in Adolescents
- ClinicalTrials.gov ID
- NCT04128644
- Acronym / sponsor ID
- 2019-03347
- Conditions
- Depression, Adolescent Development, Mental Disorder, Child
- Keywords
- depression, prevention, school
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care+Thoughts & health | Other | Behavioral: Thoughts & health, Other: Treatment as Usual12 sessions of Thoughts \& Health. Baseline questionnaires and follow up assessments |
| Standard of care | Other | Other: Treatment as UsualBaseline questionnaires and follow up assessments, intervention as usual Student Health |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Current or past depression
- Unable to function in a group session
- Current psychotherapeutic treatment
- Past or current suicidal thoughts or attempts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoughts & health12 sessions of Thoughts \& Health. Baseline questionaires and follow up assessments | Behavioural | Standard of care+Thoughts & health |
| Treatment as UsualBaseline questionnaires and follow up assessments, intervention as usual, Student Health | Other | Standard of care, Standard of care+Thoughts & health |
Primary outcome
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.
1 secondary outcome
Complete grades
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 33483440Wikberg 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josefine Lilja, PhD principal investigator
Vastra Gotaland Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoughts & health and Treatment as Usual in people with Depression and Adolescent Development, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive episode (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04128644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.