Trauma therapy for patients with PTSD and psychotic disorders
How Effective and Safe is Trauma Therapy Using Prolonged Exposure for Patients With PTSD and a Comorbid Psychotic Disorder? Treatment Trauma and Psychosis -TEP
This study is testing if a specific trauma therapy can help people with both PTSD and psychotic disorders feel better over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medicalschool Hamburg Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06048172 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Prolonged Exposure therapy for outpatients suffering from both post-traumatic stress disorder (PTSD) and a psychotic disorder. Conducted at the Medical School Hamburg, the study will randomly assign participants to receive trauma therapy or be placed in a waiting group. The trial aims to assess the reduction of PTSD and psychosis symptoms over time, with a total of 56 patients expected to be enrolled. The study will utilize a linear mixed model for data analysis, ensuring robust results despite potential dropout rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosed psychotic disorder and comorbid PTSD who are fluent in German.
Not a fit: Patients with acute suicidality, significant cognitive impairment, or recent changes in medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce PTSD and psychosis symptoms, improving the quality of life for affected patients.
How similar studies have performed: Previous studies have shown promising results for trauma therapy in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of a psychotic disorder (F20) or affective disorder with psychotic symptoms(F30) according to DSM-5. * comorbid post-traumatic stress disorder (PTSD) according to DSM-5 (CAPS-5 score ≥ 23) * At least 18 years old * Good knowledge of the German language * Willingness to participate in randomisation and trauma-focused therapy Exclusion Criteria: * Changes in neuroleptic or antidepressant therapy within the last 4 weeks (exclusion of drug effects). * Any substance dependence with continued use other than nicotine and/or caffeine dependence. * IQ of 70 or less * Acute suicidality * Pregnant women
Where this trial is running
Hamburg
- Medicalschool Hamburg — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Susanne Sarkar, Dr.
- Email: susanne.sarkar@hafencity-institut-psychotherapie.de
- Phone: 00491733968992
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.