NCT05575960

Brief Summary

The purpose of the project is to study the effectiveness of Interpersonal Psychotherapy (IPT) for adolescents with depression. Specific aims are to analyze the effects, change mechanisms, predictors, and implementation of IPT for youth. In this four-year project we will include 60 patients with depression. Outcome will be studied using a quasi-experimental multiple-baseline design. Change mechanisms will be studied in the form of mentalizing, emotion regulation, social support, and working alliance session-by-session, and with post-treatment qualitative interviews about the participants' experiences of change. Predictors of effectiveness of IPT for adolescents will be explored by measuring severity of symptoms, anxiety symptoms, presence and severity of parent-child conflicts, quality of interpersonal relationships, experiences of bullying, and school functioning. The implementation process of IPT for youth will be studied through interviews with adolescents, parents, therapists, co-workers, and local managers. The study is conducted within child and adolescent psychiatric services in Norrköping using a practice-oriented research strategy which emphasizes close collaboration with clinicians. The project is a collaboration between researchers at Linnaeus University and Linköping University, and clinicians at BUP Norrköping.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Oct 2022Jun 2027

Study Start

First participant enrolled

October 3, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

4.2 years

First QC Date

October 4, 2022

Last Update Submit

May 17, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire - 9 for depression/Eating Disorder Inventory - Very Short for eating disorder patients

    Patient-rated depression/eating disorder severity. Scale from 0-27 points, with higher scores indicating more severe symptoms.

    Change from treatment start to week 12 compared to change from before waiting-list to treatment start. In the multiple baseline design, the time for the waiting list varies, in this case about 4-25 weeks.

  • Montgomery Åsberg Depression Rating Scale (observer version) for depression/Eating Disorder Inventory for eating disorders

    Depression/eating disorder severity measures. Scale from 0-60 points, with higher scores indicating more severe symptoms..

    Change from treatment start to week 12 compared to change from before waiting-list to treatment start. In the multiple baseline design, the time for the waiting list varies, in this case about 4-25 weeks.

Study Arms (1)

Interpersonal Psychotherapy

EXPERIMENTAL

Interpersonal Psychotherapy for Adolescents according to the manual by Mufson (2004). Mufson, L. (2004). Interpersonal psychotherapy for depressed adolescents. Guilford Press.

Behavioral: Interpersonal Psychotherapy for Adolescents (IPT-A)

Interventions

Interpersonal Psychotherapy (IPT) is a psychotherapeutic treatment originally developed for treating depression in adults. It is a brief, structured treatment based on the idea of mobilizing the patient's social network, increasing his/her capacity to accept and seek support from others, and to process interpersonal difficulties, in order to improve depressive symptoms. Interpersonal psychotherapy for adolescents (IPT-A) is a version of IPT designed for young people between the age of 12-18 years with depression (Mufson, 2004), and is in many respects similar to IPT although with some modifications (e.g., a few scheduled meetings with parents during the course of treatment).

Interpersonal Psychotherapy

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Major depressive disorder according to the DSM-V
  • Age 15 to 17,5 years.
  • Good-enough knowledge in Swedish to be able to read instructions in questionnaires and who do not require an interpreter.

You may not qualify if:

  • Ongoing psychosis
  • Drug or alcohol addiction
  • Bipolar disorder
  • Suspected mental retardation
  • Acute suicidality or severe depression requiring hospitalization
  • Patients who have started antidepressant medication within the last six weeks will need to wait until medication effects have stabilized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norrköping Child and Adolescent Psychiatric Services (BUP Norrköping)

Norrköping, Sweden

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fredrik Falkenström, PhD

    Linnaeus University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrik Falkenström, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Not possible to mask psychotherapy for patient or therapist.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Multiple Baseline Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 12, 2022

Study Start

October 3, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 15, 2027

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations