Post Traumatic Stress DisorderPEPSYNCT04911010
Effectiveness of Trauma Therapy in Patients With PTSD and Comorbid Psychotic Disorder
A study testing Prolonged Exposure in people with Post Traumatic Stress Disorder and Psychotic Disorders, run by University of Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Effectiveness of trauma therapy using prolonged exposure for the treatment of post-traumatic stress disorder (PTSD) in patients with comorbid psychotic disorder Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Psychotic Disorders, Psychosis
- What is being tested?
- Prolonged Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jan 2021to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a diagnosis of a Post Traumatic Stress Disorder (PTSD spectrum disorder (ICD-10, F43.1, confirmed by SCID-5 and CAPS)
- have a diagnosis of a schizophrenia spectrum disorder (ICD-10, F2, confirmed by SCID-5)
- patients will be reporting distressing AH for at least six months (to be beyond the startle and adjustment phase ) and score ≥ 3 on either item 8 or item 9 of the PSYRATS-AH;
- be ≥ 18 years of age
- good knowledge of the German language
- Willingness to participate in randomization and trauma-focused therapy
Who cannot join
- Changes in neuroleptic or antidepressant therapy within the last 4 weeks (exclusion of drug effects)
- Any substance addiction with continued use other than nicotine and / or caffeine addiction
- IQ of 70 or less
- Acute suicidality
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hamburg
Hamburg, 20146
Susanne Sarkar, Dr., +49 40 42838-5374, susanne.sarkar@uni-hamburg.de
Esther Wolfrom, +49 40 42838-5360, klinische.psych@uni-hamburg.de
About this study
Official title: Effectiveness of Trauma Therapy Using Prolonged Exposure for the Treatment of Post-traumatic Stress Disorder (PTSD) in Patients With Comorbid Psychotic Disorder
Effectiveness of trauma therapy using prolonged exposure for the treatment of post-traumatic stress disorder (PTSD) in patients with comorbid psychotic disorder
Read the detailed description
Background and goals: Patients with psychotic disorders often report traumatizing experiences in their biography and show symptoms of a trauma-related disorder. It is assumed that around 30 percent of patients with a psychotic disorder also meet the criteria for PTSD. For the vast majority of patients, psychosis is the focus of mostly pharmacological treatment, while PTSD is not part of the therapy. In a first randomized controlled study, van den Berg's Dutch working group was able to show that psychosis patients with comorbid PTSD who were given a classic trauma exposure procedure showed a high response to PTSD symptoms (van den Berg et al., 2015). It is also important that in this study the trauma exposure did not lead to an increase in psychotic symptoms or undesirable side effects (e.g. suicidality). In order to examine the question of the generalizability of the effects, a randomized controlled study in the German-speaking health care system is necessary. In the following efficacy study in which psychosis patients with PTSD are treated using prolonged exposure. METHODS AND RESULTS: It is a multicenter, controlled, prospective, randomized study (RCT). It is investigated whether trauma therapy reduces PTSD and psychosis symptoms compared to the Treatment-As-Usual Waiting Group (TAU). The primary endpoint is the severity of the PTSD symptoms between the baseline measurement and the 6-month follow-up. Secondary endpoints are subjective PTSD symptoms, paranoia, hallucinations, and wellbeing.
- Being tested
- Prolonged Exposure
- Keywords
- PEPSY, Prolonged Exposure, trauma psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged ExposureBehavioural
Also called Trauma Therapy
In the intervention condition, patients are treated with prolonged exposure in 16 hours of individual therapy immediately after the baseline measurement. The 16 individual therapeutic sessions take place 1 to 2 sessions per week over a period of 7 to 16 weeks. The individual therapeutic sessions are recorded on video with camera focus on the therapist. Parts of the prolonged exposure procedure (reliving the traumatic memory) are recorded on tape (via the patient's personal smartphone) so that the patient can listen to the recording as homework at home. The patients then take part in a post-treatment study diagnosis (T1).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Prolonged Exposure + Treatment as usual | Experimental | Participants in this arm will receive 16 weekly sessions with Prolonged Exposure Therapy (RT) over 4 months in addition to their treatment as usual.
Interventions:
Behavioral: Prolonged Exposure Therapy Other: Treatment as usual Receives: Behavioral: Prolonged Exposure |
| Waiting-Controll-Group | No intervention | Treatment as usual Treatment as usual will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Intervention: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5 (CAPS)
The severity of the PTSD symptoms associated distress. The distress factor score of the CAPS is the primary outcome as this is what has been prioritized by patients and is relevant to functioning. Confirmatory analysis will be conducted based on the intent-to-treat population (ITT), defined on the basis of the ITT principle. The aim is to show that the intervention group is superior to the control meaning that the mean score at 6 months adjusted for the baseline value is lower in the intervention group than in the control group. Lower scores indicate less distress.
Measured: 6 months after baseline assessment
Subjective PTSD symptoms
Posttraumtatic Stress Symptom Scale Self-Report (PSSI, Foa et al., 1993)
Measured: 6 months after baseline assessment
Secondary outcomes (2)
The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)
Auditory hallucination associated distress. The distress factor score of the PSYRATS-AH is the secondary outcome. The aim is to show that the intervention group is superior to the control meaning that the mean score at 6 months adjusted for the baseline value is lower in the intervention group than in the control group. Lower scores indicate less distress.
Measured: 6 months after baseline assessment
Welleing
Wellbeing: Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, NHS Health Scotland, University of Warwick and University of Edinburgh, 2007)
Measured: 6 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start20 Jan 2021
- Primary completionJan 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Sarkar, University of Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911010
- Sponsor's protocol ID
- UHH-HSA-PEPSY
- Acronym
- PEPSY
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Trauma Therapy Using Prolonged Exposure for the Treatment of Post-traumatic Stress Disorder (PTSD) in Patients With Comorbid Psychotic Disorder
- ClinicalTrials.gov ID
- NCT04911010
- Acronym / sponsor ID
- PEPSY / UHH-HSA-PEPSY
- Keywords
- PEPSY, Prolonged Exposure, trauma psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Hamburg-EppendorfUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effectiveness of trauma therapy using prolonged exposure for the treatment of post-traumatic stress disorder (PTSD) in patients with comorbid psychotic disorder
Detailed description
Background and goals: Patients with psychotic disorders often report traumatizing experiences in their biography and show symptoms of a trauma-related disorder. It is assumed that around 30 percent of patients with a psychotic disorder also meet the criteria for PTSD. For the vast majority of patients, psychosis is the focus of mostly pharmacological treatment, while PTSD is not part of the therapy. In a first randomized controlled study, van den Berg's Dutch working group was able to show that psychosis patients with comorbid PTSD who were given a classic trauma exposure procedure showed a high response to PTSD symptoms (van den Berg et al., 2015). It is also important that in this study the trauma exposure did not lead to an increase in psychotic symptoms or undesirable side effects (e.g. suicidality). In order to examine the question of the generalizability of the effects, a randomized controlled study in the German-speaking health care system is necessary. In the following efficacy study in which psychosis patients with PTSD are treated using prolonged exposure. METHODS AND RESULTS: It is a multicenter, controlled, prospective, randomized study (RCT). It is investigated whether trauma therapy reduces PTSD and psychosis symptoms compared to the Treatment-As-Usual Waiting Group (TAU). The primary endpoint is the severity of the PTSD symptoms between the baseline measurement and the 6-month follow-up. Secondary endpoints are subjective PTSD symptoms, paranoia, hallucinations, and wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: Prolonged Exposure + Treatment as usual | Experimental | Behavioral: Prolonged ExposureParticipants in this arm will receive 16 weekly sessions with Prolonged Exposure Therapy (RT) over 4 months in addition to their treatment as usual. Interventions: Behavioral: Prolonged Exposure Therapy Other: Treatment as usual |
| Waiting-Controll-Group | No intervention | –Treatment as usual Treatment as usual will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Intervention: Other: Treatment as usual |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have a diagnosis of a Post Traumatic Stress Disorder (PTSD spectrum disorder (ICD-10, F43.1, confirmed by SCID-5 and CAPS)
- have a diagnosis of a schizophrenia spectrum disorder (ICD-10, F2, confirmed by SCID-5)
- patients will be reporting distressing AH for at least six months (to be beyond the startle and adjustment phase ) and score ≥ 3 on either item 8 or item 9 of the PSYRATS-AH;
- be ≥ 18 years of age
- good knowledge of the German language
Key exclusion criteria (5 listed)
- Changes in neuroleptic or antidepressant therapy within the last 4 weeks (exclusion of drug effects)
- Any substance addiction with continued use other than nicotine and / or caffeine addiction
- IQ of 70 or less
- Acute suicidality
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged ExposureAlso: Trauma TherapyIn the intervention condition, patients are treated with prolonged exposure in 16 hours of individual therapy immediately after the baseline measurement. The 16 individual therapeutic sessions take place 1 to 2 sessions per week over a period of 7 to 16 weeks. The individual therapeutic sessions are recorded on video with camera focus on the therapist. Parts of the prolonged exposure procedure (reliving the traumatic memory) are recorded on tape (via the patient's personal smartphone) so that the patient can listen to the recording as homework at home. The patients then take part in a post-treatment study diagnosis (T1). | Behavioural | Experimental: Prolonged Exposure + Treatment as usual |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS)
Time frame: 6 months after baseline assessment
The severity of the PTSD symptoms associated distress. The distress factor score of the CAPS is the primary outcome as this is what has been prioritized by patients and is relevant to functioning. Confirmatory analysis will be conducted based on the intent-to-treat population (ITT), defined on the basis of the ITT principle. The aim is to show that the intervention group is superior to the control meaning that the mean score at 6 months adjusted for the baseline value is lower in the intervention group than in the control group. Lower scores indicate less distress.
Subjective PTSD symptoms
Time frame: 6 months after baseline assessment
Posttraumtatic Stress Symptom Scale Self-Report (PSSI, Foa et al., 1993)
2 secondary outcomes
The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)
Time frame: 6 months after baseline assessment
Welleing
Time frame: 6 months after baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure in people with Post Traumatic Stress Disorder and Psychotic Disorders, run by University of Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne Sarkar, Dr. (00494042838-9699, susanne.sarkar@uni-hamburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (CAPS) (time frame: 6 months after baseline assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.