Effectiveness of Trauma Therapy Using Prolonged Exposure for Patients With PTSD and a Comorbid Psychotic Disorder
TEP
How Effective and Safe is Trauma Therapy Using Prolonged Exposure for Patients With PTSD and a Comorbid Psychotic Disorder? Treatment Trauma and Psychosis -TEP
1 other identifier
interventional
56
1 country
1
Brief Summary
Psychosis patients with comorbid PTSD will be treated with trauma therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2023
CompletedStudy Start
First participant enrolled
May 15, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 17, 2028
September 21, 2023
September 1, 2023
5 years
May 15, 2023
September 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (3)
subjective PTSD symptoms
baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
severity of psychosis
baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Wellbeing
baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Study Arms (2)
Waiting control group
NO INTERVENTIONThe 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.
Intervention group
EXPERIMENTALIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any substance dependence with continued use other than nicotine and/or caffeine dependence.
- IQ of 70 or less
- Acute suicidality
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medicalschool Hamburglead
- Psychiatrische Klinik Lüneburgcollaborator
- Regioklinikum Elmshorncollaborator
Study Sites (1)
Medicalschool Hamburg
Hamburg, 20457, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Treatment as usual group compared to intervention group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2023
First Posted
September 21, 2023
Study Start
May 15, 2023
Primary Completion (Estimated)
May 17, 2028
Study Completion (Estimated)
May 17, 2028
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share