PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD

Summary

The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized.

Key questions:

1. Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study?
2. Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)?
3. In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment?
4. Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy?
5. Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT?

Secondary goals:

* Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes;
* Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes;
* Investigating how much the quality of the therapeutic alliance influences outcomes.

Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom.

Conditions

• Stress Disorders, Post-Traumatic

Interventions

BEHAVIORAL

Prolonged Exposure therapy

This concerns a form of psychotherapy for PTSD.

BEHAVIORAL

Eye Movement Desensitization Reprocessing (EMDR)

This concerns a form of psychotherapy for PTSD.

BEHAVIORAL

Interpersonal Psychotherapy (IPT)

This concerns a form of psychotherapy for PTSD.

Sponsors & Collaborators

• Dimence

  collaborator UNKNOWN

• University of Groningen

  lead OTHER

Principal Investigators

• Maarten K van Dijk, PhD · Dimence

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2031-05-20

Completion

2032-08-31

Countries

• Netherlands

Study Locations