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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Groningen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults between the ages of 18 and 65 who were classified with a primary diagnosis of PTSD (based on the DSM-5 criteria).

Adults who are willing to participate in the study (informed consent)

Disqualifiers

Insufficient proficiency in the Dutch language.

Patients who cannot follow the treatment protocol (for example due to prolonged absence) are excluded from the study.

Patients who use medication that is not stable. If properly set to the last prescribed medication by the doctor there will be advised to continue and referably not change the medication and its dose during treatment, unless necessary in connection with side effects, crisis, etc.

Patients that already received an evidence-based form of trauma-oriented treatment for PTSD in the past year and for sufficient treatment duration, in accordance to the Dutch professional practice guidelines (reference: Akwa GGZ (2020, December 1). GGZ Standaarden. Psychotrauma- en stressorgerelateerde stoornissen. Retrieved September 29, 2022, from https://www.ggzstandaarden.nl/zorgstandaarden/psychotrauma-en-stressorgerelateerde-stoornissen/introductie).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prolonged Exposure therapy

    Behavioral

    This concerns a form of psychotherapy for PTSD.

  • Eye Movement Desensitization Reprocessing (EMDR)

    Behavioral

    This concerns a form of psychotherapy for PTSD.

  • Interpersonal Psychotherapy (IPT)

    Behavioral

    This concerns a form of psychotherapy for PTSD.

Treatment groups

442 Participants
are divided into 3 treatment groups
Group A: Prolonged ExposureActive comparator 1 intervention
Group B: Eye Movement Desensitization ReprocessingActive comparator 1 intervention
Group C: Interpersonal PsychotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PTSD Checklist for DSM-5 (PCL-5)

The primary outcome measure for the effectiveness of the treatment in both phases is symptom reduction (less burden of PTSD symptoms) measured with the PTSD checklist for the DSM-5 (PCL-5). The Dutch version of the PCL-5 will be used, the PCL-5 is administered at baseline and repeated weekly. The PCL-5 is a self-report questionnaire of 20 items about the DSM-5 symptoms of PTSD. This measure will be used to monitor symptom change during and after treatment in both phases of the study.

Time frame
Measured every week for 8 weeks in phase 1 and measured every week of 8 weeks in phase 2 of the study.

Secondary outcomes

1

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

The Dutch version of the CAPS-5 will be used as it is "the gold standard" in PTSD assessment. The CAPS-5 is a 30-item structured clinical interview that we will use, among other things, to determine the current (past month) diagnosis of PTSD and to assess improvement in symptoms since a previous CAPS administration.

Time frame
Measured at baseline, at the end of treatment in phase 1 (= after 8 weeks) and at the end of the treatment in phase 2 (= after 16 weeks = end of the study).
2

International Trauma Questionnaire (ITQ)

The Dutch version of the ITQ will be used: "Internationale Trauma Vragenlijst" (ITV). The International Trauma Questionnaire (ITQ) is a self-report questionnaire consisting of 18 items that measures complex PTSD (C-PTSD) symptoms according to the diagnostic criteria of the 11th revision of the International Classification of Diseases (ICD-11; World Health Organization).

Time frame
Measured at baseline, at the end of treatment in phase 1 (= after 8 weeks) and at the end of the treatment in phase 2 (= after 16 weeks = end of the study).
3

Hospital Anxiety and Depression Scale (HADS)

The Dutch version of the HADS will be used. The Hospital Anxiety and Depression Scale is a 14-item self-report questionnaire and can be used to measure levels of anxiety and depression.

Time frame
Measured every week for 8 weeks in phase 1 and measured every week of 8 weeks in phase 2 of the study.
4

Mental Health Continuum Short Form (MHC-SF)

The Dutch version of the MHC-SF will be used: the Dutch short-form Mental Health Continuum. The MHC-SF comprises 40 items that measure emotional well-being, psychological well-being and social well-being.

Time frame
Measured at baseline, at the end of treatment in phase 1 (= after 8 weeks) and at the end of the treatment in phase 2 (= after 16 weeks = end of the study).

Other outcomes

1

Age

We are investigating generic predictors of treatment success and specific moderators based on the scientific literature. Further, we have added several instruments to match those that Wibbelink et al. (2021) use in their research in order to be able to collaborate in future data analyses (PAI analysis). The first demographic variable is age.

Time frame
Measured at baseline.
2

Gender

We ask about gender.

Time frame
Measured at baseline.
3

Education

We ask about the level of education.

Time frame
Measured at baseline.
4

Employment

We ask about employment status.

Time frame
Measured at baseline.

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