Clinical trial NCT06048172: Effectiveness of Trauma Therapy Using Prolonged Exposure for Patients With PTSD and a Comorbid Psychotic Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
PTSD
Psychosis
Keywords: PTSD
schizophrenia
Prolonged Exposure
Lead sponsor: Medicalschool Hamburg
Sponsor class: OTHER
Collaborators: name: Psychiatrische Klinik Lüneburg
name: Regioklinikum Elmshorn
First posted: 2023-09-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trail (RCT).
Primary purpose: TREATMENT

Brief summary: Psychosis patients with comorbid PTSD will be treated with trauma therapy.

Detailed description: This is a monocentric, controlled, prospective, randomised trial. (RCT). The study population is outpatients with psychotic illness and comorbid post-traumatic stress disorder who have applied for outpatient psychotherapy at the psychotherapeutic outpatient clinic (HSA) of the Medical School Hamburg. It will be investigated whether trauma therapy (Prolonged Exposure) reduces PTSD and psychosis symptoms in comparison to the waiting group. The study will be conducted from 01.09.2023 to 30.04.2028. Patients with suitable symptoms should be seen in the psychotherapeutic outpatient (psychotherapeutic consultation hours) at the HSA should be made aware of the study.

In the next step, a detailed diagnosis is made and, if consent is given and the inclusion criteria listed below are met, the patients are enrolled in the study.

The sample size for the longitudinal intent-to-treat (ITT) analysis with a linear mixed model (LMM) was chosen. Models (LMM) was calculated based on a previous RCT (Van den Berg et al., 2016, effect size for PE in CAPS versus waitlist (TAU) d = 0.78, p \< 0.001; effect size for PE in paranoia versus waitlist (TAU) d = 0.62, p = .005). ITT analyses with LLM are relatively robust to missing data, despite which we calculate a 20% dropout rate. With an alpha of 0.05; a mean effect size of 0.5, 3 measurement replicates (baseline measurement T0, post-treatment T1, 6-month follow-up after post, T2), we require 28 patients per treatment arm. A total of 56 patients will be included in the study.

Eligibility 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

Primary outcomes:
measure: severity of PTSD symptoms
timeFrame: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
measure: Remission of PTSD diagnosis
timeFrame: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Secondary outcomes:
measure: subjective PTSD symptoms
timeFrame: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
measure: severity of psychosis
timeFrame: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
measure: Wellbeing
timeFrame: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Medicalschool Hamburg
Study officials:
References: