Adolescent Interpersonal Counseling in Primary Care

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06390462
• Other study ID #: 1271/6.02.03/2024
• Status: Recruiting
• Start date: March 25, 2024
• Est. completion date: December 2039

Study information

• Verified date: April 2024
• Source: Finnish Institute for Health and Welfare
• Contact: Outi Linnaranta, MD, PhD
• Phone: +358504327128
• Email: outi.linnaranta[@]thl.fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9000
• Est. completion date: December 2039
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Symptoms Mild to Moderate in Severity
• Major Depressive Disorder

Intervention

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.
• 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

Locations

Country	Name	City	State
Finland	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

Sponsors (5)

Lead Sponsor	Collaborator
Finnish Institute for Health and Welfare	Strategic Research Council of Finland, Tampere University, University of Eastern Finland, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

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

External Links

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