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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).

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). - PT-STRESS study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53245
Enrollment
442
Registered
2023-03-20
Start date
2023-12-21
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

posttraumatic stress disorder, PTSD, trauma posttraumatic stress disorder, PTSD, trauma

Interventions

Half of initially non-responsive patients will be treated with the non-trauma-focused intervention interpersonal therapy (IPT) in phase 2 of the study. The first and second phases will offer the traum
Markowitz, 2019). PTSD following a traumatic life event produces social withdrawal and a blunted, inhibited emotional life, disrupting interpersonal functioning. IPT helps benumbed patients recognize
Arntz, 2017). - In EMDR, patients are distracted from the traumatic memories by a dual attention task, usually using eye movements. This study will use a protocolled EMDR treatment for PTSD (De Jongh
Ten Broeke, 2019).

Sponsors

Dimence Groep
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 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).

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure for treatment effectiveness in both phases is PTSD symptom reduction measured with the PTSD Checklist for the DSM-5 (PCL-5; Boeschoten, Bakker, Jongedijk, & Olff, 2014). The PCL-5 is administered at baseline and repeated weekly. The week 8 assessment serves as the endpoint of phase 1 and the start measurement of phase 2. The PCL-5 is also administered weekly in phase 2.

Secondary

MeasureTime frame
Secondary outcome measures are the CAPS-5, ITV, HADS, MHC-SF and PNEP. In addition, we shall measure variables to investigate generic predictors of treatment success and specific moderators. Based on the literature, it appears that the following variables may affect outcome. 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).  * Demographic variables: age, gender, education, employment, marital status, ethnicity/race, medication use, treatment history.  * Mini-SCAN, LEC-5, CTQ-SF, ECR-RS, SCL-90 hostility subscale, BEAQ, IAPT, PTCI, TRGI, TRSI, WAV-12 and an expectancy rating for both patients and therapists.

Countries

Netherlands

Contacts

Public ContactM Schaufeli

Dimence Groep

m.vandijk@dimence.nl(06) 57 30 63 33

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026