Depressive Symptoms Mild to Moderate in SeverityNCT06390462
Adolescent Interpersonal Counseling in Primary Care
An observational study of Depressive Symptoms Mild to Moderate in Severity and Major Depressive Disorder, run by Finnish Institute for Health and Welfare at 4 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms Mild to Moderate in Severity, Major Depressive Disorder
- What is being tested?
- Interpersonal counseling, Treatment as usual and No support, intervention or other treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9,000 participants
- Where
- 4 sitesFinland
- Study dates
- 25 Mar 2024to Dec 2039
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents attending grades 7 to 9 (13 to 16 years) in selected schools
Who may be able to join
- we will include all adolescents attending grades 7 to 9 in selected schools with on informed consent
Who cannot join
- psychiatric care within the past 12 months or receiving a psychosocial intervention (psychotherapy, IPC-A, any other therapy of support) during the 12 months before baseline,
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland4 sites, 4 recruiting
- Recruiting
The wellbeing services county of Kanta-Häme
Hämeenlinna
Jasmin Kaljadin, MSc, jasmin.kaljadin@thl.fi
Riittakerttu Kaltiala, MD, PhD
- Recruiting
Finnish Institute for Health and Welfare
Helsinki, 02710
Outi Linnaranta, MD, PhD, +358504327128, outi.linnaranta@thl.fi
Jasmin Kaljadin, MSc, jasmin.kaljadin@thl.fi
- Recruiting
The wellbeing services county of Central Finland
Jyväskylä
Tiia-Reeta Kukko, MSc, tiia-reeta.kukko@thl.fi
Jasmin Kaljadin, jasmin.kaljadin@thl.fi
- Recruiting
The wellbeing services county of North Ostrobothnia
Oulu
Ulla Heikkilä, MSc, ulla.heikkila@thl.fi
Jasmin Kaljadin, MSc
About this study
Official title: Adolescent Depression Treatment Pathways in Primary Care - a Longitudinal Cohort Study Describing Naturalistic Flow of Treatment and Evaluating Effectiveness and Cost-effectiveness of Interpersonal Counseling Compared to Treatment as Usual
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Interpersonal counseling, Treatment as usual, No support, intervention or other treatment
- Keywords
- adolescent, depression, prospective, cohort study, interpersonal counseling, prevention, therapy, effectiveness, cost-effectiveness, predictor, economic evaluation
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal counselingBehavioural
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 usualBehavioural
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 treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with sustained depression | PHQ-9-A ≥ 10 at least twice in a 6 months follow-up Receives: Behavioral: Interpersonal counseling; Behavioral: Treatment as usual; Other: No support, intervention or other treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 12 months
Secondary outcomes (2)
Proportion of adolescents who received any social welfare or health care services
Data collected from adolescent and caretaker's surveys and registers
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start25 Mar 2024
- Primary completionMay 2026 (estimated)
- Study completionDec 2039 (estimated)
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 Depressive Symptoms Mild to Moderate in SeverityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Strategic Research Council of Finland, University of Helsinki, University of Eastern Finland, Tampere University
- Responsible party
- Sponsor
- Investigators
- Outi Linnaranta, MD, PhD, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390462
- Sponsor's protocol ID
- 1271/6.02.03/2024
- Status last verified
- Aug 2025
- First submitted
- 19 Mar 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Linnaranta O, Myllyniemi A, Salusjarvi E, Seilo N, Kaljadin J, Kukko TR, Tani S, Kaltiala R, Koskinen T, Karukivi M, Karvonen J, Karri S, Oksanen J, Heinonen E, Kiviruusu O, Therman S, Berg P, Lahti J, Rissanen E, Lammintakanen J, Ranta K, Autio R, Marttunen M. Did national implementation of interpersonal counseling improve adolescent depression treatment pathways in primary care? Protocol for a longitudinal cohort study. BMC Public Health. 2026 Jun 10. doi: 10.1186/s12889-026-26466-6. Online ahead of print.
PubMed 42271350
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Depression Treatment Pathways in Primary Care - a Longitudinal Cohort Study Describing Naturalistic Flow of Treatment and Evaluating Effectiveness and Cost-effectiveness of Interpersonal Counseling Compared to Treatment as Usual
- ClinicalTrials.gov ID
- NCT06390462
- Acronym / sponsor ID
- 1271/6.02.03/2024
- Keywords
- adolescent, depression, prospective, cohort study, interpersonal counseling, prevention, therapy, effectiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Strategic Research Council of Finland, University of Helsinki, University of Eastern Finland, Tampere University
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2039 (estimated)
- First posted
- 30 Apr 2024 (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.
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:
- 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.
Detailed description
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with sustained depression | – | Behavioral: Interpersonal counseling, Behavioral: Treatment as usual, Other: No support, intervention or other treatmentPHQ-9-A ≥ 10 at least twice in a 6 months follow-up |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents attending grades 7 to 9 (13 to 16 years) in selected schools
Key inclusion criteria (1 listed)
- we will include all adolescents attending grades 7 to 9 in selected schools with on informed consent
Key exclusion criteria (3 listed)
- psychiatric care within the past 12 months or receiving a psychosocial intervention (psychotherapy, IPC-A, any other therapy of support) during the 12 months before baseline,
- 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.
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 |
|---|---|---|
| Interpersonal counselingA 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. | Behavioural | Adolescents with sustained depression |
| Treatment as usualAny other behavioral or medical support or depression indicated by depressive symptoms or depression. This is based on adolescent, caretaker and professional's report. | Behavioural | Adolescents with sustained depression |
| No support, intervention or other treatmentThe 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 | Other | Adolescents with sustained depression |
Primary outcome
Proportion of adolescents referred to specialized psychiatric services
Time frame: From baseline to 12 months
Proportion of adolescents in each three groups with sustained depressive symptoms by 6 months who receive specialized psychiatric services by 12 months
2 secondary outcomes
Proportion of adolescents who received any social welfare or health care services
Time frame: Up to 10 years after baseline
longitudinal changes in PHQ-9-A score
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Derived from this study: PubMed 42271350Linnaranta O, Myllyniemi A, Salusjarvi E, Seilo N, Kaljadin J, Kukko TR, Tani S, Kaltiala R, Koskinen T, Karukivi M, Karvonen J, Karri S, Oksanen J, Heinonen E, Kiviruusu O, Therman S, Berg P, Lahti J, Rissanen E, Lammintakanen J, Ranta K, Autio R, Marttunen M. Did national implementation of interpersonal counseling improve adolescent depression treatment pathways in primary care? Protocol for a longitudinal cohort study. BMC Public Health. 2026 Jun 10. doi: 10.1186/s12889-026-26466-6. Online ahead of print.
- Description in Finnish and in English about the study, participant informed consent (adolescent, caretaker, professional)Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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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.
Outi Linnaranta, MD, PhD principal investigator
Finnish Institute for Health and Welfare
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Symptoms Mild to Moderate in Severity and Major Depressive Disorder, run by Finnish Institute for Health and Welfare at 4 sites in Finland.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Outi Linnaranta, MD, PhD (+358504327128, outi.linnaranta@thl.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of adolescents referred to specialized psychiatric services (time frame: From baseline to 12 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 NCT06390462, 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 19 Aug 2025.