Adolescent Interpersonal Counseling in Primary Care

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:

• 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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder; Depressive Symptoms Mild to Moderate in Severity
• Intervention / Treatment: Behavioral: Interpersonal counseling; Behavioral: Treatment as usual; Other: No support, intervention or other treatment

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 Type: Observational
• Enrollment (Estimated): 9000

Contacts and Locations

• Study Contact: Name: Outi Linnaranta, MD, PhD; Phone Number: +358504327128; Email: outi.linnaranta@thl.fi
• Study Contact Backup: Name: Jasmin Kaljadin, MSc; Phone Number: +358295247728; Email: jasmin.kaljadin@thl.fi

Study Locations

• Finland
  • Helsinki, Finland, 02710
    • Recruiting
    • Finnish Institute for Health and Welfare
    • Principal Investigator: Outi Linnaranta, MD, PhD
    • Contact: Outi Linnaranta, MD, PhD; Phone Number: +358504327128; Email: outi.linnaranta@thl.fi
    • Contact: Jasmin Kaljadin, MSc; Email: jasmin.kaljadin@thl.fi
  • Hämeenlinna, Finland
    • Recruiting
    • The wellbeing services county of Kanta-Häme
    • Contact: Jasmin Kaljadin, MSc; Email: jasmin.kaljadin@thl.fi
    • Principal Investigator: Riittakerttu Kaltiala, MD, PhD
  • Jyväskylä, Finland
    • Recruiting
    • The wellbeing services county of Central Finland
    • Contact: Tiia-Reeta Kukko, MSc; Email: tiia-reeta.kukko@thl.fi
    • Contact: Jasmin Kaljadin; Email: jasmin.kaljadin@thl.fi
    • Principal Investigator: Tarja Koskinen, MD
  • Oulu, Finland
    • Recruiting
    • The wellbeing services county of North Ostrobothnia
    • Contact: Ulla Heikkilä, MSc; Email: ulla.heikkila@thl.fi
    • Contact: Jasmin Kaljadin, MSc
    • Principal Investigator: Juha T Karvonen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adolescents attending grades 7 to 9 (13 to 16 years) in selected schools

Description

Inclusion Criteria:

• we will include all adolescents attending grades 7 to 9 in selected schools with on informed consent

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adolescents with sustained depression; PHQ-9-A ≥ 10 at least twice in a 6 months follow-up

Behavioral: 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.; Behavioral: 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.; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of adolescents who received any social welfare or health care services	Data collected from adolescent and caretaker's surveys and registers	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	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness	One item: Do you feel lonely? yes/no	No time frame
Experiences of Social Inclusion Scale	10 items, 0 to 4, higher score more inclusion	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	The same day
Generalized Anxiety Disorder Scale-7	GAD-7, 7 items 0 to 3, higher score more anxiety	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	2 weeks
Young Person's Clinical Outcomes in Routine Evaluation-Outcome Measure	YP-CORE; 10 items 0 to 4, higher score better outcome	1 week
3x10D life situation assessment tool	3x10-Dx, 10 items 0 to 0, higher score better life situation	No time frame
Harmful behavior: Alcohol and substance use, self-harming behavior	Questions yes/no, open field	Ever, past 30 days

Collaborators and Investigators

• Sponsor: Finnish Institute for Health and Welfare
• Collaborators: University of Helsinki; Tampere University; University of Eastern Finland; Strategic Research Council of Finland
• Investigators: Principal Investigator: Outi Linnaranta, MD, PhD, Finnish Institute for Health and Welfare

Publications and helpful links

Helpful Links

• Description in Finnish and in English about the study, participant informed consent (adolescent, caretaker, professional)

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2039

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: depression; adolescent; effectiveness; prevention; cohort study; cost-effectiveness; prospective; therapy; economic evaluation; interpersonal counseling; predictor
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 1271/6.02.03/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: First baseline IPD available from fall 2025 for 10 years, final economic evaluation data will be stored from 2039 for 10 years
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No