An observational study in Depressive Symptoms Mild to Moderate in Severity and Major Depressive Disorder, sponsored by Finnish Institute for Health and Welfare. Recruiting at 4 sites in Finland. Open to participants aged 13 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Finnish Institute for Health and Welfare · Observational
The demand for prevention and treatment of adolescent depression has rapidly increased over years. A national project to improve treatment of adolescent depression in primary care has taken place in Finland starting 2020.
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:
Adolescents who participate in the study will
We will also collect
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.
Background: Implementation of evidence-based interventions is one of the proposed responses to increased demand for prevention and treatment of adolescent depression. A national implementation of adolescent interpersonal counseling (IPC-A) has taken place in Finland starting 2020. While the efficacy of interpersonal psychotherapy (IPT-A) as an intervention to treat depression of adolescents is well established, the effectiveness and cost-effectiveness of the shorter adaptation, IPC-A, remains open. Investigators present a protocol for an evaluation of pathways to mental health services of depressed adolescents and a prospective, observational community-based cohort study to estimate the effectiveness and cost-effectiveness of IPC-A, as compared to adolescents with sustained depression with treatment as usual or no treatment.
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 9,000 is above the median of 131 across 400 observational studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Finnish Institute for Health and Welfare is the lead sponsor of 42 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adolescents attending grades 7 to 9 (13 to 16 years) in selected schools
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PHQ-9-A ≥ 10 at least twice in a 6 months follow-up
Behavioral: Interpersonal counseling · Behavioral: Treatment as usual · Other: No support, intervention or other treatment
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.
Any other behavioral or medical support or depression indicated by depressive symptoms or depression. This is based on adolescent, caretaker and professional's report.
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
Proportion of adolescents referred to specialized psychiatric services
Proportion of adolescents in each three groups with sustained depressive symptoms by 6 months who receive specialized psychiatric services by 12 months
Time frame: From baseline to 12 months
Proportion of adolescents who received any social welfare or health care services
Data collected from adolescent and caretaker's surveys and registers
Time frame: Up to 10 years after baseline
longitudinal changes in PHQ-9-A score
Longitudinal changes in biweekly PHQ-9-A scores over 6 months; PHQ-9-A 10 items, 0 to 3, higher score more depression
Time frame: 2 weeks
Loneliness
One item: Do you feel lonely? yes/no
Time frame: No time frame
Experiences of Social Inclusion Scale
10 items, 0 to 4, higher score more inclusion
Time frame: No time frame
The child-friendly EuroQol-5 dimensions questionnaire
EQ-5D-Y, 5 items 0 to 2; a VAS scale, higher score more functional
Time frame: The same day
Generalized Anxiety Disorder Scale-7
GAD-7, 7 items 0 to 3, higher score more anxiety
Time frame: 2 weeks
The Short Warwick-Edinburg Mental Wellbeing Scale
SWEMWBS, 7 items for positive mental health 0 to 4, higher score more positive mental health
Time frame: 2 weeks
Young Person's Clinical Outcomes in Routine Evaluation-Outcome Measure
YP-CORE; 10 items 0 to 4, higher score better outcome
Time frame: 1 week
3x10D life situation assessment tool
3x10-Dx, 10 items 0 to 0, higher score better life situation
Time frame: No time frame
Harmful behavior: Alcohol and substance use, self-harming behavior
Questions yes/no, open field
Time frame: Ever, past 30 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Mauri Marttunen and Klaus Ranta: effectiveness and psychometrics; Johanna Lammintakanen: cost-effectiveness and economic evaluation; Jari Lahti: motivation to treatment; Erkki Heinonen: Therapist competence and outcome
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: First baseline IPD available from fall 2025 for 10 years, final economic evaluation data will be stored from 2039 for 10 years
Access criteria: Data access is restricted by user roles with permission of PI (Outi Linnaranta), and all data will be pseudonymized. Sensitive register data including person IDs will be managed using the Findata Kapseli service.
Data sharing details ↗ · stnimagine.fi
Started Mar 2024 (actual). Primary completion is estimated for May 2026, 26 months after the start.
Of 121 non-industry observational studies under Depressive Disorder, Major, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 73. This study's planned 26 months is below that.
Counting every sponsor, half of 150 studies reached it within 38 months; a quarter within 21 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
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Finnish Institute for Health and Welfare