Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents

NCT03001245 | Unknown

• 1 other identifier: HUS 1277/2016
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this cluster randomized trial is to investigate whether the brief, 1+6 session psychosocial intervention, Interpersonal Counseling (IPC) is more effective than standard professional treatment (ST) in the treatment of mild or moderate depression among 12 to 17-year-old adolescents in services provided by school health care and counseling professionals (school nurses, school psychologists and school social workers). The clients are identified from the pool of adolescents routinely seen in school health care and counseling services. A total of 54 school nurses, social workers, and psychologists from all public secondary schools in the standard education system of City of Espoo, Finland will be trained in IPC in a three-day workshop in two waves. Each school (plus the one primary care level health care unit for adolescents in Espoo) is represented by 1-3 trial IPC counselors. In the first wave the schools are cluster randomized to provide either A) 1+6 sessions of IPC, or B) 1+6 sessions of standard treatment (ST), which consists of psychosocial work as guided by the workers' own standard professional principles and methods. The workers randomized to deliver IPC get the IPC training immediately. In the second wave those who delivered ST in the first wave will be trained in IPC. The data for this trial will be collected from the first wave. The data collection period is one school year plus follow-up of clients after 3 and 6 months. The clients are adolescents who have either self-referred themselves, are referred by other school personnel, or by parents to the services offered in the school due to emotional symptoms in the school year 2016 -2017 in the participating schools. They are screened with the BDI at the initial visit to identify depressive symptoms. A diagnostic interview will be administered to those exceeding a clinical cutoff. Main inclusion criterion is DSM-5 depressive disorder of either mild or moderate severity. Those with current harmful alcohol use, acute suicidal ideation or behavior, severe depression or anxiety disorder, psychotic symptoms or very low global level of functioning are excluded and offered other treatment. The clients will complete self-report questionnaires (BDI) as outcome measures. Their level of depression symptoms will also be assessed with ADRS scale and their level of global psychosocial functioning with the CGAS by the project IPC counselors / ST providers. Moreover, the clients will complete the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) as a measure of global symptomatology after each session. A follow-up interview at 3 months and 6 months after treatment termination will be arranged. The K-SADS-PL will be used for diagnostic evaluation, the ADRS and the C-GAS to assess level of depressive symptoms and global functioning, and the adolescent completes both the BDI and YP-CORE as self-reports of symptomatology.

Conditions

Depressive Disorder

Keywords

adolescents; depression; psychotherapy; interpersonal therapy

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Adolescent Depression Rating Scale after six scheduled treatment sessions

  6 weeks

• Change from Baseline in Children's Global Assessment of Functioning after six scheduled treatment sessions

  6 weeks

• Change from Baseline in Beck Depression Inventory after six scheduled treatment sessions

  6 weeks

• Change from Baseline in Young Person's Clinical Outcomes for Routine Evaluation after six scheduled treatment sessions

  one, two, three, four, five, and six weeks

Secondary Outcomes (10)

• Change from Baseline in diagnostic status regarding depressive disorder assessed with Kiddie-Sads-Present and Lifetime Version 3 months after treatment termination

  3 months after treatment termination

• Change from Baseline in diagnostic status regarding depressive disorder assessed with Kiddie-Sads-Present and Lifetime Version 6 months after treatment termination

  6 months after treatment termination

• Change from Baseline in Adolescent Depression Rating Scale 3 months after treatment termination

  3 months after treatment termination

• Change from Baseline in Adolescent Depression Rating Scale 6 months after treatment termination

  6 months after treatment termination

• Change from Baseline in Beck Depression Inventory 3 months after treatment termination

  3 months after treatment termination

Study Arms (2)

IPC

EXPERIMENTAL

Interpersonal Counseling

Behavioral: Interpersonal Counseling

ST

ACTIVE COMPARATOR

Standard treatment

Behavioral: Standard treatment

Interventions

Interpersonal Counseling BEHAVIORAL

Interpersonal Counseling 1+6 sessions

IPC

Standard treatment BEHAVIORAL

Psychosocial treatment 1+6 sessions guided by the professional's standard professional principles and routinely available methods

ST

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of DSM-5 Depressive Disorder (severity mild or moderate)

You may not qualify if:

• current harmful alcohol use
• acute suicidal ideation or behavior
• severe depressive disorder
• severe anxiety disorder
• psychotic symptoms
• very low global level of functioning

Sponsors & Collaborators

• Hospital District of Helsinki and Uusimaa: lead
• Ministry of Social Affairs and Health; Finland: collaborator
• Finnish Institute for Health and Welfare: collaborator
• City of Espoo: collaborator

Study Sites (1)

Department of Adolescent Psychiatry, Helsinki University Central Hospital

Helsinki, P. O.Box 590, FI-00029, Finland

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Klaus Y Ranta, M.D., Ph.D.

  Hospital District of Helsinki and Uusimaa, Helsinki University Central Hospital

  STUDY CHAIR

• Mauri Marttunen, M.D., Ph.D.

  University of Helsinki, Department of Adolesecent Psychiatry

  STUDY DIRECTOR

Central Study Contacts

Klaus Y Ranta, M.D., Ph.D.

CONTACT

+358-50-4284185; klaus.ranta@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department, Department of Adolescent Psychiatry, Helsinki University Central Hospital

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 22, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

FI (1)