Post Traumatic Stress Disorder, Psychosis, PTSD
Conditions
Keywords
PTSD, schizophrenia, Prolonged Exposure
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.
Interventions
BEHAVIORALProlonged 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.
Sponsors
Psychiatrische Klinik Lüneburg
Regioklinikum Elmshorn
Medicalschool Hamburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Treatment as usual group compared to intervention group.
Intervention model description
Randomised controlled trail (RCT).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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). |
| Wellbeing | 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) |
Countries
Germany
Contacts
Primary ContactSusanne Sarkar, Dr.
Backup ContactFriederike Meyer, Dr.
Outcome results
None listed