Trauma therapy for patients with PTSD and psychotic disorders
Official title: How Effective and Safe is Trauma Therapy Using Prolonged Exposure for Patients With PTSD and a Comorbid Psychotic Disorder? Treatment Trauma and Psychosis -TEP
Run by Medicalschool Hamburg · NCT06048172 · Data updated 2026-11-12
This study is testing if a specific trauma therapy can help people with both PTSD and psychotic disorders feel better over time.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Medicalschool Hamburg Academic / other |
| Locations | 1 site (Hamburg) |
| Status | Recruiting |
| Started | May 15, 2023 |
| Main results expected | May 17, 2028 |
| Study ends | May 17, 2028 |
| Registry record updated | September 21, 2023 |
| Trial ID | NCT06048172 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a diagnosed psychotic disorder and comorbid PTSD who are fluent in German.
✕Probably not a fit
Patients with acute suicidality, significant cognitive impairment, or recent changes in medication may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results for trauma therapy in similar populations, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
-
Medicalschool Hamburg
Hamburg, Germany Recruiting
Study contacts
- Study coordinator: Susanne Sarkar, Dr.
- Email: susanne.sarkar@hafencity-institut-psychotherapie.de
- Phone: 00491733968992
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study will test whether the handheld gammaCore device, which delivers mild electrical stimulation to the vagus nerve through the neck, can help adults with PTSD reduce their symptoms.
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Non‑trauma PTSD treatment for veterans and service members with mild or moderate TBI
This pilot will test a non‑trauma psychotherapy program to help veterans and service members with mild or moderate traumatic brain injury who have PTSD.
-
Psilocybin-assisted therapy for PTSD after sexual assault
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Short-term therapy for PTSD symptoms
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Augmented reality-enhanced exposure therapy for PTSD in U.S. military personnel
This tests whether adding augmented reality to standard exposure therapy helps U.S. military veterans and active-duty adults with PTSD.
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Working memory training to improve fear extinction in veterans with PTSD
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.