Trauma therapy for PTSD in patients with psychotic disorders
Effectiveness of Trauma Therapy Using Prolonged Exposure for the Treatment of Post-traumatic Stress Disorder (PTSD) in Patients With Comorbid Psychotic Disorder
This study is testing if a specific trauma therapy can help people with PTSD who also have a psychotic disorder feel better compared to those who are receiving standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT04911010 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of prolonged exposure therapy for treating post-traumatic stress disorder (PTSD) in patients who also have a comorbid psychotic disorder. It aims to determine whether this trauma therapy can reduce PTSD and psychosis symptoms compared to a Treatment-As-Usual Waiting Group. The study is a multicenter, controlled, prospective, randomized trial, focusing on the severity of PTSD symptoms over a six-month follow-up period. Secondary outcomes include assessments of paranoia and hallucinations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of PTSD and a schizophrenia spectrum disorder who have been experiencing distressing auditory hallucinations for at least six months.
Not a fit: Patients with acute suicidality, recent changes in medication, or substance addiction may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for patients suffering from both PTSD and psychotic disorders.
How similar studies have performed: Previous studies have shown promising results for trauma therapy in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * have a diagnosis of a Post Traumatic Stress Disorder (PTSD spectrum disorder (ICD-10, F43.1, confirmed by SCID-5 and CAPS) * have a diagnosis of a schizophrenia spectrum disorder (ICD-10, F2, confirmed by SCID-5) * patients will be reporting distressing AH for at least six months (to be beyond the startle and adjustment phase ) and score ≥ 3 on either item 8 or item 9 of the PSYRATS-AH; * be ≥ 18 years of age * good knowledge of the German language * Willingness to participate in randomization and trauma-focused therapy Exclusion Criteria: * Changes in neuroleptic or antidepressant therapy within the last 4 weeks (exclusion of drug effects) * Any substance addiction with continued use other than nicotine and / or caffeine addiction * IQ of 70 or less * Acute suicidality * Pregnant women
Where this trial is running
Hamburg
- University Hamburg — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Susanne Sarkar, Dr.
- Email: susanne.sarkar@uni-hamburg.de
- Phone: 00494042838-9699
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.