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

Primary Purpose

Post Traumatic Stress Disorder, PTSD, Psychosis

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Prolonged Exposure
Sponsored by
Medicalschool Hamburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD, schizophrenia, Prolonged Exposure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medicalschool HamburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waiting control group

Intervention group

Arm Description

The patients in the treatment-as-usual control group remain on the waiting list for 14 weeks after the baseline measurement. After 14 weeks, they participate in the study diagnostics post-treatment at time point.

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.

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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).
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).
Wellbeing
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, NHSHealth Scotland, University of Warwick and University of Edinburgh, 2007)

Full Information

First Posted
May 15, 2023
Last Updated
September 15, 2023
Sponsor
Medicalschool Hamburg
Collaborators
Psychiatrische Klinik Lüneburg, Regioklinikum Elmshorn
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1. Study Identification

Unique Protocol Identification Number
NCT06048172
Brief Title
Effectiveness of Trauma Therapy Using Prolonged Exposure for Patients With PTSD and a Comorbid Psychotic Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
May 17, 2028 (Anticipated)
Study Completion Date
May 17, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicalschool Hamburg
Collaborators
Psychiatrische Klinik Lüneburg, Regioklinikum Elmshorn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, PTSD, Psychosis
Keywords
PTSD, schizophrenia, Prolonged Exposure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trail (RCT).
Masking
Participant
Masking Description
Treatment as usual group compared to intervention group.
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Waiting control group
Arm Type
No Intervention
Arm Description
The patients in the treatment-as-usual control group remain on the waiting list for 14 weeks after the baseline measurement. After 14 weeks, they participate in the study diagnostics post-treatment at time point.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure
Other Intervention Name(s)
trauma therapy, PE
Intervention Description
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.
Primary Outcome Measure Information:
Title
severity of PTSD symptoms
Description
Clinical-Administered PTSD Scale for DSM-5 (CAPS, Blake etal., 1998), presence of PTSD and score for severity of PTSD symptoms
Time Frame
baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Title
Remission of PTSD diagnosis
Description
Clinical-Administered PTSD Scale for DSM-5 (CAPS, Blake etal., 1998), presence of PTSD diagnosis (cut-off score lower than 23)
Time Frame
baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Secondary Outcome Measure Information:
Title
subjective PTSD symptoms
Description
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).
Time Frame
baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Title
severity of psychosis
Description
Psychotic Symptom Rating Scales (PSYRATS, Haddock et al.,1991), score for severity of delusions (PSYRATS-DRS) and for severity of auditory hallucinations (PSYRATS-AHRS).
Time Frame
baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Title
Wellbeing
Description
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, NHSHealth Scotland, University of Warwick and University of Edinburgh, 2007)
Time Frame
baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Sarkar, Dr.
Phone
00491733968992
Email
susanne.sarkar@hafencity-institut-psychotherapie.de
First Name & Middle Initial & Last Name or Official Title & Degree
Friederike Meyer, Dr.
Phone
004917672116907
Email
friederike.meyer@hafencity-institut-psychotherapie.de
Facility Information:
Facility Name
Medicalschool Hamburg
City
Hamburg
ZIP/Postal Code
20457
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Sarkar, Dr.
Phone
00491733968992
Email
susanne.sarkar@hafencity-institut-psychotherapie.de

12. IPD Sharing Statement

Plan to Share IPD
No

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

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