Increasing Treatment Response Rates in Depressed Adolescents Via Feedback-Informed IPDT

NCT06193772 | Completed

• 1 other identifier: SU-308-0226-23
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching research project aims to evaluate of an internet-delivered affect-focused psychodynamic treatment (IPDT) for adolescents aged 15-19 with depression. The previous study was a non-inferiority randomized controlled trial (RCT) comparing IPDT with internet-delivered cognitive behavior therapy (ICBT). The results showed that IPDT and ICBT had similar effects. Adolescents in both treatments showed large improvements in both depression and other outcome measures. Online psychological treatment is also known as guided self-help, where the participant reads texts and performs exercises on their own, with the support of an online therapist. The planned study is an RCT to investigate the effect of therapist feedback and customized treatment for adolescents at risk of not being helped by IPDT. The study builds on analyses of predicted treatment trajectories in the project's previous study. Based on these analyses, algorithms have been developed that identify which young people who, after three weeks of treatment, are at risk of not getting a good outcome from the treatment. In the present study, 240 young people aged 15-19 with major depression will begin IPDT. After three weeks of treatment, the course of the treatment is analyzed using the algorithm and the young people who are at risk of not having a good outcome are identified. These adolescents are randomized to either continue unchanged treatment or to receive detailed therapist feedback on the adolescent's treatment prognosis and instructions to adapt the treatment in consultation with the individual adolescent. The IPDT treatment consists of eight modules and treatment duration is ten weeks. The study evaluates the effect of the treatment on depression and other variables such as anxiety symptoms, emotion regulation and self-image. The project's previous studies have shown that IPDT is an effective treatment that can be offered to adolescents with depression. The planned study can show whether the outcome of IPDT can be further improved by paying attention to adolescents with poorer treatment progress and adapting the treatment more to their needs.

Conditions

Depression in Adolescence

Outcome Measures

Primary Outcomes (1)

• Response to treatment according to the proportion improvement method

  treatment response is defined as over 50% improvement within the pathological range and at least 25% improvement within the total range on the Quick Inventory of Depressive Symptomatology in Adolescents Self-Rated (QIDS-A17-SR)

  Pre-treatment and after 10 weeks (end of treatment)

Secondary Outcomes (5)

• Severity of depressive symptoms

  Pre-treatment, weekly during treatment, after 10 weeks (end of treatment) and one-year follow-up

• Anxiety symptoms

  Pre-treatment, post-treatment, one-year follow-up

• Difficulties in emotion regulation

  Pre-treatment and after 10 weeks (end of treatment)

• Self-concept and identity

  Pre-treatment, after 10 weeks (end of treatment), one-year follow-up

• Defence mechanism functioning

  Pre-treatment and after 10 weeks (end of treatment)

Study Arms (3)

IPDT as usual for "on track" patients

ACTIVE COMPARATOR

IPDT as usual for patients who are identified as "on track" at week 3.

Behavioral: Internet-delivered psychodynamic therapy (IPDT)

IPDT adapted for "at risk" patients

EXPERIMENTAL

Customized IPDT after therapist feedback for patients who are identified as "at risk" at week 3.

Behavioral: Internet-delivered psychodynamic therapy (IPDT)

IPDT as usual for "at risk" patients

ACTIVE COMPARATOR

IPDT as usual for patients who are identified as "at risk" at week 3.

Behavioral: Internet-delivered psychodynamic therapy (IPDT)

Interventions

Internet-delivered psychodynamic therapy (IPDT) BEHAVIORAL

IPDT consists of 8 therapist-supported self-help modules delivered over 10 weeks on a secure online platform. Modules consist of texts and video followed by assignments which they send to their therapist and receive feedback within a few days. The intervention "IPDT adapted" starts with therapist feedback about the patient's predicted progress and continues with adapting the treatment to the individual adolescent, for example adding text chat sessions.

IPDT adapted for "at risk" patients; IPDT as usual for "at risk" patients; IPDT as usual for "on track" patients

Eligibility Criteria

• Age: 15 Years - 19 Years
• Gender Eligibility Details: Self-reported gender identity with alternatives 1) female, 2) male, 3) other alternative, 4) uncertain, 5) do not want to answer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents 15-19 years of age suffering from mild to moderate major depressive disorder (MDD) according to DSM-5 as established through a diagnostic interview (MINI 7.0 Sheehan et al., 1998). MDD should be the primary diagnosis. Participants must have access to a computer/smart phone/tablet with internet connection, and be able to read, write and speak Swedish without the aid of an interpreter.

Sponsors & Collaborators

• Björn Philips: lead
• Kavli Trust: collaborator
• Linkoeping University: collaborator

Study Sites (1)

Department of Psychology, Stockholm University

Stockholm, 10691, Sweden

Location

Study Officials

• Björn Philips, Ph.D.

  Stockholm University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: All eligible participants (n = 240) will be entered into IPDT. At week 3 in treatment, participants at risk of non-response will be identified using our open-source algorithm. Identified participants at risk will be randomized to either adapted treatment or continued IPDT as usual.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 5, 2024
• Study Start: January 26, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study protocol will be published before the end of enrollment.
• Access Criteria: IPD will be shared to other researchers for IPD meta-analyses after reasonable request. The principal investigator will review requests.

Locations

SE (1)