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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Prolonged Exposure therapy
BehavioralThis concerns a form of psychotherapy for PTSD.
Eye Movement Desensitization Reprocessing (EMDR)
BehavioralThis concerns a form of psychotherapy for PTSD.
Interpersonal Psychotherapy (IPT)
BehavioralThis concerns a form of psychotherapy for PTSD.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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).
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.
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.
Other outcomes
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.
Gender
We ask about gender.
Education
We ask about the level of education.
Employment
We ask about employment status.
Sponsors and contacts
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University of Groningen
Lead sponsor
Dimence
Collaborator