Understanding and improving treatments for PTSD
PT-STRESS Study: A Two-phase RCT Aimed at Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD; by Alternating Between Two Trauma-focused Treatments (EMDR/PE) or by Switching to Interpersonal Therapy (IPT)
This study is trying to find better ways to help adults with PTSD by testing different therapy options to see if switching treatments can improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 442 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Groningen Academic / other |
| Locations | 1 site (Deventer) |
| Trial ID | NCT06279598 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the effectiveness of psychological treatments for adults with post-traumatic stress disorder (PTSD) by identifying predictors of treatment success and exploring alternative therapies for those who do not respond to initial treatments. It investigates three psychotherapeutic approaches: Eye Movement Desensitization and Reprocessing (EMDR), Prolonged Exposure (PE), and Interpersonal Psychotherapy (IPT). The study will assess whether switching therapies or offering additional treatments can improve outcomes for patients who experience insufficient response to their first treatment. By personalizing treatment options, the study seeks to address the significant number of patients who do not benefit from standard therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a primary diagnosis of PTSD who are willing to participate in the study.
Not a fit: Patients who have received evidence-based trauma-oriented treatment for PTSD in the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with PTSD.
How similar studies have performed: Other studies have shown success with similar approaches in personalizing PTSD treatment, but this study aims to further refine and expand on those findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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). * Patients with serious suicidality that requires acute intervention and structural addition of additional treatment interventions. * Patients with an intellectual disability. * Patients with a serious addiction as a comorbid problem. * Patients with an acute mania or a psychotic state.
Where this trial is running
Deventer
- Dimence — Deventer, Netherlands (Recruiting)
Study contacts
- Principal investigator: Maarten K van Dijk, PhD — Dimence
- Study coordinator: Maarten K van Dijk, PhD
- Email: m.vandijk@dimence.nl
- Phone: +31 0570-604000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.