Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06279598

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

Led by University of Groningen · Updated on 2024-02-28

442

Participants Needed

1

Research Sites

452 weeks

Total Duration

On this page

Sponsors

U

University of Groningen

Lead Sponsor

D

Dimence

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults between 18 and 65 years old with a primary diagnosis of PTSD based on DSM-5 criteria
  • Willing to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Insufficient proficiency in the Dutch language
  • Inability to follow the treatment protocol (e.g., due to prolonged absence)
  • Unstable medication use or planned changes during treatment unless medically necessary
  • Prior evidence-based trauma-focused PTSD treatment in the past year for sufficient duration
  • Serious suicidality requiring acute intervention
  • Intellectual disability
  • Serious addiction as a comorbid condition
  • Acute mania or psychotic state

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dimence

Deventer, Netherlands

Actively Recruiting

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Research Team

M

Maarten K van Dijk, PhD

CONTACT

D

Dominique Jonkers, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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