Post-traumatic stress disorder, schizophrenia, psychosis Mental and Behavioural Disorders Post-traumatic stress disorder, schizophrenia, psychosis
Conditions
Interventions
Treatment arm: Trauma-focused Cognitive Behavioural Therapy for psychosis. TF-CBTp is a manualised therapy integrating standard psychological treatments for PTSD and for psychosis. It will be delivere
Sponsors
South London and Maudsley NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 09/10/2020: PTSD symptoms in the past month will be assessed on the CAPS-5. The CAPS-5 is a semi-structured interview assessing the severity of symptoms delineated in DSM-5. The CAPS-5 consists of seven criteria (Criteria A to G). Scores are anchored to an index event, which will be elicited using the mini-TALE and TALE checklists. The index event could be a single trauma experience or multiple, closely related incidents. In this study meeting Criterion A will not be a requirement (i.e., only events including actual or threatened death, serious injury, or sexual violence), as we will include events related to psychosis and its consequences (e.g., involuntary admission or forced restraint), emotional and physical neglect, discrimination and attachment disrupting experiences, as possible index events. PTSD diagnostic status will be determined by an algorithm of minimum scores on specific items from Criteria B to E, and meeting Criteria F and G, according to DSM-5 diagnostic rules. Once the index event has been ascertained, the severity of symptoms is scored on a 5-point scale (‘absent’ to ‘extreme’) on four criteria: (i) Criterion B: Re-experiencing symptoms; (ii) Criterion C: Avoidance symptoms; (iii) Criterion D: Cognitions and mood symptoms; (iv) Criterion E: Arousal and reactivity symptoms. Criteria F and G are scored dichotomously (Yes/No) on whether the duration of the experience is more than 1m, and has caused subjective distress and impairment in functioning, respectively. The total symptom severity score (total of 20 item scores on Criteria B to E) will be the primary outcome _____ Previous primary outcome measure: PTSD symptoms in the past month will be assessed on the CAPS-5 at baseline, 4 months (mid-therapy), 9 months (end of therapy; primary endpoint), and 24 months (15 months post-therapy) post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/10/2020: At baseline, 4 months (mid-therapy), 9 months (end of therapy; primary endpoint), and 24 months (15 months post-therapy) post-randomisation unless otherwise stated: 1. Symptoms: 1.1. PTSD: 1.1.1. Percentage of people who achieve a loss of their PTSD diagnosis, as determined by the CAPS-5 diagnostic status algorithm 1.1.2. Percentage of people who show clinically significant change in CAPS-5 scores 1.1.3. CAPS-5 individual symptom clusters (severity scores for the individual Criteria B to E) 1.1.4. Self-reported PTSD symptoms and their associated appraisals and responses will be assessed on standardised, commonly used questionnaires: 1.1.4.1. International Trauma Questionnaire 1.1.4.2. Brief Version of the Posttraumatic Cognitions Inventory (PTCI-9) 1.1.4.3. The Dissociative Subtype of PTSD Scale (DSPS) 1.2. Psychosis: 1.2.1. The Psychosis Symptoms Rating Scales (PSYRATS). Additional items to cover hallucinations in non-auditory modalities (i.e., visual, somatic, olfactory and sense of presence), and whether these are experienced at the same or different times (multi-modality), will be included 1.2.2. The Revised Green et al Paranoid Thoughts Scale (GPTS-R) 2. Emotional well-being: 2.1. Depression assessed using the short form of the Depression Anxiety Stress Scales (DASS-21) 2.2. Suicidal ideation will be assessed using the Paykel Suicidal Feelings Scale (PSFS) 2.3. Drug use measured using the Brief Version of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) 3. Psychological Recovery: The Short Version of the CHOICE (CHoice of Outcome In Cbt for psychosEs) scale 4. Social and occupational functioning: The Personal and Social Performance Scale (PSP) 5. Health-related quality of life: the EQ-5D-5L 6. Health-related quality of life for users of mental health services: the ReQoL-10 7. Service-use: A modified version of the AD-SUS, designed and successfully applied in psychosis populations Ther | — |
Countries
England, United Kingdom
Outcome results
None listed