Study Results
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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RECRUITING
9000 participants
OBSERVATIONAL
2024-03-25
2039-12-31
Brief Summary
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The goal of this prospective observational cohort study is to describe pathways to mental health services in adolescents with depressive symptoms. The main questions it aims to answer are:
* Do young people reporting depressive symptoms have equal access to treatment?
* How is it best to recognize those adolescents who will benefit from IPC-A?
Adolescents who participate in the study will
* complete a survey on protective and risk factors of depression three times over 6 months
* report possible depressive symptoms every two weeks over 6 months
* report whether they needed and received help, motivation for treatment, and benefits and harms from treatment
We will also collect
* information from one of caretakers with two surveys within 6 month- intervals on their view on adolescent's need for support, strengths and risks, and benefits and harms from treatment where applicable
* where applicable, from the professional who provided support after the intervention on their training and competence, as well as content of and response to treatment
* register data to estimate overall provision and cost of social welfare and health care services one year preceding the study and over 2 to 10 years after the observation period
Researchers will compare an intervention that is new in Finland, adolescent interpersonal counseling (IPC-A), to other treatments of depression, to see if it is equal to or better than other treatments of depression.
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Detailed Description
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Methods: The cohort will include grade 7 to 9 adolescents (13-16-year-olds) in selected Finnish schools, excluding adolescents with preceding treatment of depression. A universal prospective evaluation of adolescents in a 6-month follow-up will provide information on the proportion of adolescents a) with sustained depression over the follow-up period (Patient Health Questionnaire 9 items, PHQ-9 ≥ 10) in two measurements over 6 months), b) with a self-reported need for support due to depressive symptoms, and c) with a therapeutic intervention. The investigators will describe the treatment received (number of sessions, therapeutic content) based on reports from adolescents, caretakers, and therapists, as well as electronic patient records. The primary outcome measure will be the proportion of adolescents who will receive specialized psychiatric services by 12 months after baseline. Secondary outcome measures comparing three groups as defined at 6 months (IPC-A, treatment as usual (TAU), or no treatment group). They will include proportion of adolescents who received any support by 12 months after baseline, and longitudinal changes in PHQ-9-A scores by 12 months. Cost-effectiveness will be evaluated using survey data at 12 months, and an economic evaluation using register data and information on service use 12 months before and 2 and 10 years after baseline. Collection of survey data is expected to start in March 2024 and is set to finish in May 2025.
Discussion: The study will describe need for, pathways to, and content of social and health services for depressed adolescents. Benefits and harms of treatment and the national implementation will be observed. The results can improve detection and equal access to care, and inform decision-makers about the best practices for prevention, including utility of the implementation of IPC-A.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Adolescents with sustained depression
PHQ-9-A ≥ 10 at least twice in a 6 months follow-up
Interpersonal counseling
A structured psychotherapeutic intervention to prevent depression or treat mild to moderate depression. IPC-A is a brief, individual-based intervention (3-8 sessions). The focus is on interpersonal relations as a factor of resilience in depressive symptoms. IPC-A is a shorter form of IPT-A, developed by prof. Myrna Weissman and team.
Treatment as usual
Any other behavioral or medical support or depression indicated by depressive symptoms or depression. This is based on adolescent, caretaker and professional's report.
No support, intervention or other treatment
The group will comprise those adolescents who report sustained depression but do not seek or receive support over 6 months of follow-up based on adolescent and caretaker's report
Interventions
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Interpersonal counseling
A structured psychotherapeutic intervention to prevent depression or treat mild to moderate depression. IPC-A is a brief, individual-based intervention (3-8 sessions). The focus is on interpersonal relations as a factor of resilience in depressive symptoms. IPC-A is a shorter form of IPT-A, developed by prof. Myrna Weissman and team.
Treatment as usual
Any other behavioral or medical support or depression indicated by depressive symptoms or depression. This is based on adolescent, caretaker and professional's report.
No support, intervention or other treatment
The group will comprise those adolescents who report sustained depression but do not seek or receive support over 6 months of follow-up based on adolescent and caretaker's report
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* an inability to reliably understand the Finnish, Plain Finnish, Swedish, or English versions of the survey, or
* an adolescents' or caretakers' report of a need for exclusion, such as another medical condition - including a mental disorder - requiring acute current treatment or support.
13 Years
16 Years
ALL
Yes
Sponsors
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Strategic Research Council of Finland
UNKNOWN
University of Helsinki
OTHER
University of Eastern Finland
OTHER
Tampere University
OTHER
Finnish Institute for Health and Welfare
OTHER_GOV
Responsible Party
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Principal Investigators
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Outi Linnaranta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Finnish Institute for Health and Welfare
Locations
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The wellbeing services county of Kanta-Häme
Hämeenlinna, , Finland
Finnish Institute for Health and Welfare
Helsinki, , Finland
The wellbeing services county of Central Finland
Jyväskylä, , Finland
The wellbeing services county of North Ostrobothnia
Oulu, , Finland
Countries
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Central Contacts
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Facility Contacts
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Jasmin Kaljadin, MSc
Role: backup
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Description in Finnish and in English about the study, participant informed consent (adolescent, caretaker, professional)
Other Identifiers
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1271/6.02.03/2024
Identifier Type: -
Identifier Source: org_study_id
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