ISRCTN93382525Active, not recruiting未知
Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis (TF-CBTp) to reduce post-traumatic stress disorder (PTSD) symptoms in patients with co-morbid PTSD and psychosis, compared to treatment as usual: the STAR (Study of Trauma And Recovery) trial
South London and Maudsley NHS Foundation Trust0 sites305 target enrollmentStarted: August 3, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Enrollment
- 305
Study Overview
Brief Summary
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35606886/ (added 24/05/2022)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current inclusion criteria as of 12/10/2020:
- •1. Presence of SSD (F20-29 diagnoses; International Statistical Classification of Diseases and Related Health Problems, 10th Edition; (ICD-10) from clinical notes review, if necessary supplemented by information from the care team
- •2. Scoring 2 or above ('moderate' intensity) on the intensity of distress item of the Delusions and/or Hallucinations Psychosis Symptom Rating Scales (PSYRATS), adapted to include hallucinations in all modalities
- •3. Reporting past trauma(s), occurring at least 1 month prior to assessment, including those related to psychotic breakdown or its treatment, assessed using the TALE Checklist
- •4. Reporting still being currently affected by at least one traumatic event, assessed using the mini-TALE and TALE Checklists
- •5. Scoring 2 or above ('moderately') on one of the five re-experiencing items from the PCL-5
- •6. Meet DSM-5 PTSD diagnostic criteria, assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which includes the criteria of 1m stability of symptoms and demonstrable link between the index trauma event(s) and presenting symptoms
- •7. Both individuals on antipsychotic treatment, and those who decline to take medication, will be included, as long as no medication changes have occurred in the previous 3 months (i.e., having started or stopped antipsychotic medication, or a switch to or from clozapine)
- •8. Aged 18 years and above
- •9. Able and willing to engage in psychological therapy and consent to study procedures
- •Previous inclusion criteria:
- •1. Presence of SSD (F20-29 diagnoses; International Statistical Classification of Diseases and Related Health Problems, 10th Edition; (ICD-10) from clinical notes review, if necessary supplemented by information from the care team
- •2. Scoring 2 or above (‘moderate’ intensity) on the intensity of distress item of the Delusions and/or Hallucinations Psychosis Symptom Rating Scales (PSYRATS), adapted to include hallucinations in all modalities
- •3. Reporting past trauma(s), occurring at least 1 month prior to assessment, including those related to psychotic breakdown or its treatment, assessed using the TALE Checklist
- •4. Scoring 2 or above (‘moderately’) on one of the five re-experiencing items from the PCL-5
- •5. Meet DSM-5 PTSD diagnostic criteria, assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which includes the criteria of 1m stability of symptoms and demonstrable link between the index trauma event(s) and presenting symptoms
- •6. Both individuals on antipsychotic treatment, and those who decline to take medication, will be included, as long as no medication changes have occurred in the previous 3 months (i.e., having started or stopped antipsychotic medication, or a switch to or from clozapine)
- •7. Aged 18 years and above
- •8. Able and willing to engage in psychological therapy and consent to study procedures
Exclusion Criteria
- •1. Current, primary diagnosis of substance use disorder
- •2. Organic factors implicated in the primary aetiology of psychosis and/or PTSD
- •3. Current (or in previous 3 months) engagement in trauma-focused therapy*
- •4. Insufficient English to provide informed consent or complete assessments without the help of an interpreter
- •5. Currently experiencing an acute mental health crisis
- •*(i.e., any therapy that focuses on reprocessing trauma memories; therapies such as CBTp would be operationalised as ‘trauma-informed’ rather than ‘trauma-focused’, since they may include past traumatic experiences in the developmental formulation, but would not include memory work) (added 23/11/2020)
Investigators
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