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| Name | Class |
|---|---|
| Psychiatrische Klinik Lüneburg | UNKNOWN |
| Regioklinikum Elmshorn | UNKNOWN |
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Psychosis patients with comorbid PTSD will be treated with trauma therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waiting control group | No Intervention | 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. | |
| Intervention group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne Sarkar, Dr. | Contact | 00491733968992 | susanne.sarkar@hafencity-institut-psychotherapie.de | |
| Friederike Meyer, Dr. | Contact | 004917672116907 | friederike.meyer@hafencity-institut-psychotherapie.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicalschool Hamburg | Recruiting | Hamburg | 20457 | Germany |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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Randomised controlled trail (RCT).
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Treatment as usual group compared to intervention group.
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| 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) |
| 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) |