Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment56 (estimated)
SponsorMedicalschool Hamburg
Academic / other
Locations1 site (Hamburg)
StatusRecruiting
StartedMay 15, 2023
Main results expectedMay 17, 2028
Study endsMay 17, 2028
Registry record updatedSeptember 21, 2023
Trial IDNCT06048172 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.