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

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ClinicalTrials.gov Identifier: NCT06048172
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborators:
Psychiatrische Klinik Lüneburg
Regioklinikum Elmshorn
Information provided by (Responsible Party):
Medicalschool Hamburg

Study Description
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Brief Summary:
Psychosis patients with comorbid PTSD will be treated with trauma therapy.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder PTSD Psychosis Behavioral: Prolonged Exposure Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trail (RCT).
Masking: Single (Participant)
Masking Description: Treatment as usual group compared to intervention group.
Primary Purpose: Treatment
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
Actual Study Start Date : May 15, 2023
Estimated Primary Completion Date : May 17, 2028
Estimated Study Completion Date : May 17, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Waiting control group
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.
Experimental: Intervention group
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.
 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.
Other Names:
  • trauma therapy
  • PE


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    Clinical-Administered PTSD Scale for DSM-5 (CAPS, Blake etal., 1998), presence of PTSD and score for severity of PTSD symptoms

  2. Remission of PTSD diagnosis [ Time Frame: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months) ]
    Clinical-Administered PTSD Scale for DSM-5 (CAPS, Blake etal., 1998), presence of PTSD diagnosis (cut-off score lower than 23)


Secondary Outcome Measures :
  1. subjective 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) ]
    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).

  2. severity of psychosis [ Time Frame: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months) ]
    Psychotic Symptom Rating Scales (PSYRATS, Haddock et al.,1991), score for severity of delusions (PSYRATS-DRS) and for severity of auditory hallucinations (PSYRATS-AHRS).

  3. Wellbeing [ Time Frame: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months) ]
    Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, NHSHealth Scotland, University of Warwick and University of Edinburgh, 2007)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048172


Contacts
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Contact: Susanne Sarkar, Dr. 00491733968992 susanne.sarkar@hafencity-institut-psychotherapie.de
Contact: Friederike Meyer, Dr. 004917672116907 friederike.meyer@hafencity-institut-psychotherapie.de

Locations
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Germany
Medicalschool Hamburg Recruiting
Hamburg, Germany, 20457
Contact: Susanne Sarkar, Dr.    00491733968992    susanne.sarkar@hafencity-institut-psychotherapie.de   
Sponsors and Collaborators
Medicalschool Hamburg
Psychiatrische Klinik Lüneburg
Regioklinikum Elmshorn
More Information
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Responsible Party: Medicalschool Hamburg
ClinicalTrials.gov Identifier: NCT06048172    
Other Study ID Numbers: MSH
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medicalschool Hamburg:
PTSD
schizophrenia
Prolonged Exposure
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Psychotic Disorders
 Mental Disorders
Trauma and Stressor Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders