NCT06279598: PT-STRESS

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

Recruiting now NA Last updated 28 February 2024

What this trial tests

NA trial testing Prolonged Exposure therapy in Stress Disorders, Post-Traumatic in 442 participants. Currently enrolling.

Timeline

1 January 2024

Primary endpoint
20 May 2031

31 August 2032

Quick facts

Lead sponsor	University of Groningen
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	442
Start date	1 January 2024
Primary completion	20 May 2031
Estimated completion	31 August 2032
Sites	1 location across Netherlands

Drugs / interventions tested

• Prolonged Exposure therapy
• Eye Movement Desensitization Reprocessing (EMDR)
• Interpersonal Psychotherapy (IPT)

Conditions studied

• Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →

Sponsor

University of Groningen

Who can join

Adults 18 to 65, any sex, with Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.