Effectiveness of Trauma Therapy Using Prolonged Exposure for Patients With PTSD and a Comorbid Psychotic Disorder

PTSD Clinical Trial

— TEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048172
• Other study ID #: MSH
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: May 17, 2028

Study information

• Verified date: September 2023
• Source: Medicalschool Hamburg
• Contact: Susanne Sarkar, Dr.
• Phone: 00491733968992
• Email: susanne.sarkar[@]hafencity-institut-psychotherapie.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Psychosis patients with comorbid PTSD will be treated with trauma therapy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: May 17, 2028
• Est. primary completion date: May 17, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Post Traumatic Stress Disorder
• Psychosis
• Psychotic Disorders
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure
In the intervention condition, patients are treated directly after the baseline measurement by Prolonged Exposure in 16 hours of individual therapy. The 16 individual therapy sessions will take place in 1 to 2 sessions per week over a period of 7 to 16 weeks. The individual therapy sessions are videotaped with camera focus on the therapist. Parts of the Prolonged Exposure process (the re-experiencing of the traumatic memory) are recorded on tape, so that the patient can listen to the recording as homework at home. Afterwards, the patients take part in a study diagnostic session.

Locations

Country	Name	City	State
Germany	Medicalschool Hamburg	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Medicalschool Hamburg	Psychiatrische Klinik Lüneburg, Regioklinikum Elmshorn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of PTSD symptoms	Clinical-Administered PTSD Scale for DSM-5 (CAPS, Blake etal., 1998), presence of PTSD and score for severity of PTSD symptoms	baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Primary	Remission of PTSD diagnosis	Clinical-Administered PTSD Scale for DSM-5 (CAPS, Blake etal., 1998), presence of PTSD diagnosis (cut-off score lower than 23)	baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Secondary	subjective PTSD symptoms	sum score of the Posttraumatic Stress Symptom Scale Self-Report (PSSI, Foa et al., 1993), PTSD Di-agnostic Scale (PDS-5, Foa et al., 2013).	baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Secondary	severity of psychosis	Psychotic Symptom Rating Scales (PSYRATS, Haddock et al.,1991), score for severity of delusions (PSYRATS-DRS) and for severity of auditory hallucinations (PSYRATS-AHRS).	baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Secondary	Wellbeing	Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, NHSHealth Scotland, University of Warwick and University of Edinburgh, 2007)	baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)