STAR (Study of Trauma And Recovery): a trial of trauma-focused psychological therapy for psychosis

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

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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

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

Therapy group only:
8. Acceptability:
A sub-section of the participants will be offered interviews once they have finished therapy to explore acceptability and satisfaction with the therapy. Close attention will be paid to any emotional distress resulting from memory exposure procedures, in particular potential impact on psychotic symptoms, and whether this was considered unacceptable or unnecessary. The view of those who decided to terminate therapy prematurely will also be gathered, using additional questions about their reasons for doing so and to identify barriers and potential solutions to engagement in therapy.
Therapists will be interviewed once they have completed therapy with two or three participants to obtain feedback about acceptability, and any potential difficulties in delivery.
Experts by experience researchers with lived experience of psychosis will conduct the participant interviews, with appropriate supervision and support, and therapists will be interviewed by Research Workers. It is anticipated that the final patient sample will be representative and include variance on key variables (e.g., intervention engagement, age, gender, ethnicity, clinical presentation). All interview data will be audio-recorded, with participants’ permission, and transcribed verbatim for analysis.
Participants’ experience of the research assessments will be evaluated following the baseline assessment and at the last assessment (24m) using a brief feedback form, to capture any potential negative and positive aspects.
10. Therapeutic alliance:
Therapeutic alliance between therapists and participants randomised to the intervention arm will be measured using the Working Alliance Inventory – Short Form Revised (WAI-SF-R (81). The therapist and client versions cover three key aspects of alliance: agreement on therapy tasks, agreement on therapy goals and the development of an affective bond (81). Both the self-report participant and therapist versions will be administered.



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Previous secondary outcome measures:
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 Adult Suicidal Ideation Questionnaire Short Version (ASIQ-SV)
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
8. Acceptability:
A sub-section of the participants will be offered interviews once they have finished therapy to explore acceptability and satisfaction with the therapy. Close attention will be paid to any emotional distress resulting from memory exposure procedures, in particular potential impact on psychotic symptoms, and whether this was considered unacceptable or unnecessary. The view of those who decided to terminate therapy prematurely will also be gathered, using additional questions about their reasons for doing so and to identify barriers and potential solutions to engagement in therapy.
Therapists will be interviewed once they have completed therapy with two or three participants to obtain feedback about acceptability, and any potential difficulties in delivery.
Experts by experience researchers with lived experience of psychosis will conduct the participant interviews, with appropriate supervision and support, and therapists will be interviewed by Research Workers. It is anticipated that the final patient sample will be representative and include variance on key variables (e.g., intervention engagement, age, gender, ethnicity, clinical presentation). All interview data will be audio-recorded, with participants’ permission, and transcribed verbatim for analysis.
Participants’ experience of the research assessments will be evaluated following the baseline assessment and at the last assessment (24m) using a brief feedback form, to capture any potential negative and positive aspects.