STAR (Study of Trauma And Recovery): a trial of trauma-focused psychological therapy for psychosis
- Conditions
- Post-traumatic stress disorder, schizophrenia, psychosisMental and Behavioural Disorders
- Registration Number
- ISRCTN93382525
- Lead Sponsor
- South London and Maudsley NHS Foundation Trust
- Brief Summary
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35606886/ (added 24/05/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 305
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
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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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method