PT-STRESS study: a two-phase randomized study aimed at predicting and coping with non-response in the treatment of PTSD; the latter by alternating recommended trauma-focused treatments (EMDR/T-CBT), or by switching to interpersonal therapy (IPT).
- Conditions
- posttraumatic stress disorderPTSDtrauma10002861
- Registration Number
- NL-OMON53245
- Lead Sponsor
- Dimence (Deventer)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 442
- Adults between the ages of 18 and 65 who were classified at intake with a
primary diagnosis of PTSD (based on the DSM-5 criteria).
- Adults who are willing to participate in the research (informed consent).
- Insufficient mastery of the Dutch language.
- Patients who cannot follow the treatment protocol (for example due to
long-term absence) are excluded from the study.
- Patients who use medication that is not stable. If properly adjusted to the
last prescribed medication, the medication is continued as advised by the
doctor and preferably not changed during the treatment, unless necessary due to
side effects, crisis, et cetera.
- Patients who have already received a proven effective form of trauma-focused
treatment for PTSD earlier in the past year (of a sufficiently long duration
according to the guidelines of the standard of care and sufficiently well
implemented to be effective).
- Patients with severe suicidality, which requires acute intervention and the
structural addition of additional treatment interventions (such as
hospitalization).
- Patients with a (mild) intellectual disability.
- Patients with a serious addiction as a comorbid problem.
- Patients with an acute mania or a psychotic state.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure for treatment effectiveness in both phases is PTSD<br /><br>symptom reduction measured with the PTSD Checklist for the DSM-5 (PCL-5;<br /><br>Boeschoten, Bakker, Jongedijk, & Olff, 2014). The PCL-5 is administered at<br /><br>baseline and repeated weekly. The week 8 assessment serves as the endpoint of<br /><br>phase 1 and the start measurement of phase 2. The PCL-5 is also administered<br /><br>weekly in phase 2.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are the CAPS-5, ITV, HADS, MHC-SF and PNEP.<br /><br>In addition, we shall measure variables to investigate generic predictors of<br /><br>treatment success and specific moderators. Based on the literature, it appears<br /><br>that the following variables may affect outcome. Further, we have added several<br /><br>instruments to match those that Wibbelink et al. (2021) use in their research<br /><br>in order to be able to collaborate in future data analyses (PAI analysis).<br /><br>* Demographic variables: age, gender, education, employment, marital status,<br /><br>ethnicity/race, medication use, treatment history.<br /><br>* Mini-SCAN, LEC-5, CTQ-SF, ECR-RS, SCL-90 hostility subscale, BEAQ, IAPT,<br /><br>PTCI, TRGI, TRSI, WAV-12 and an expectancy rating for both patients and<br /><br>therapists.</p><br>