Schizophrenia, schizotypal and delusional disorders Mental and Behavioural Disorders Schizophrenia, schizotypal and delusional disorders
Conditions
Interventions
Current intervention as of 04/10/2021:
Design: A randomised controlled trial (RCT) with two participant groups will be used. The trial will include an internal pilot to test CaFI’s feasibility with Af
Sponsors
Greater Manchester West Mental Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
14 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 04/10/2021: Service users: 1. People of Sub-Saharan African and Caribbean descent, including those who self-identify as ‘Black British’, ‘Black Caribbean’, ‘Black African’, ‘African-Caribbean’ or ‘Mixed’ African/Caribbean 2. At least one parent/grandparent born in a sub-Saharan African/Caribbean country 3. Diagnosis of schizophrenia or related psychoses (ICD F20-29/ DSM-V) (American Psychiatric Association, 2013; World Health Organization, 1992) 4. Receiving treatment via psychiatric inpatient services (acute or rehabilitation), forensic or within community services within a participating NHS Trust 5. 14 years or older in keeping with the age groups served by Early Intervention Services and adult services 6. Assessed by researchers as having the capacity to provide informed consent 7. Assessed by care teams as being well enough to participate in therapy 8. Sufficient understanding of the English language to complete measures 9. No significant cognitive impairment implicated in aetiology (e.g. organic disorder) 10. Does not present a high short-term risk to themselves or others as assessed by care teams Family members and nominated Family Support Members (FSMs): Family members and nominated family support members do not have to be of African or Caribbean origin. All participants: 1. Assessed by researchers as having the capacity to provide informed consent 2. Family members and nominated FSMs must be aged 14 years or older 3. Sufficient proficiency in English to enable completion of measures _____ Previous inclusion criteria as of 05/02/2021: 1. People of Sub-Saharan African and Caribbean descent, including those who self-identify as ‘Black British’, ‘Black Caribbean’, ‘Black African’, ‘African-Caribbean’ or ‘Mixed’ African/Caribbean 2. At least one parent/grandparent born in a Sub Saharan Africa/Caribbean country 3. Diagnosis of schizophrenia or related psychoses (ICD F20-29/ DSM-V) (American Psychiatric Association, 2013; World Health Organization, 1992) 4. Receiving treatment via psychiatric inpatient services (acute or rehabilitation), forensic or within community services within a participating NHS Trust 5. Aged 14 years or older in keeping with the age groups served by early intervention services and adult services 6. Assessed by researchers as having the capacity to provide informed consent 7. Assessed by care teams as being well enough to participate in therapy 8. Sufficient understanding of the English language to complete measures. We anticipate that the majority of participants will meet this criterion. However, we shall evaluate it during the acceptability work and early in recruitment and modify if necessary to ensure we do not exclude groups with some of the highest need e.g. people seeking asylum. 9. No significant cognitive impairment implicated in aetiology (e.g. organic disorder) 10. Do not present a high short-term risk to themselves or others as assessed by care teams. _____ Previous inclusion criteria: 1. Ethnicity: People of Sub-Saharan African and Caribbean descent, including those who self-identify as ‘Black British’, ‘Black Caribbean’, ‘Black African’, ‘African-Caribbean’, or ‘Mixed’ African/Caribbean’ 2. Diagnosis: Schizophrenia or related diagnoses (ICD F20-29/ DSM-IV). We shall exclude to those with non-psychotic or organic brain disorder or cognitive impairment 3. Capacity: Assessed by Care Coordinators/key workers as having the capacity to provide informed consent and
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 04/10/2021: Service users: 1. Organic brain disorder 2. Cognitive impairment sufficient to impact completion of assessment measures 3. Substance use as primary diagnosis 4. Currently receiving any form of family intervention Family members and nominated Family Support Members (FSMs): 1. Service user does not meet ethnicity or diagnostic criteria 2. Cognitive impairment sufficient to impact completion of assessment measures 3. Inability to understand study information or to give informed consent and complete measures _____ Previous exclusion criteria as of 05/02/2021: 1. Organic brain disorder 2. Cognitive impairment sufficient to impact completion of assessment measures 3. Substance use as primary diagnosis. 4. Currently receiving any form of family intervention _____ Previous exclusion criteria: 1. As substance use often co-occurs with psychoses, this will not be an exclusion criterion unless it is the primary diagnosis 2. Under the age of 14. However, family members under 14 (e.g. siblings) can participate if they are able to give assent, depending on parental/guardian consent 3. Family members, and FSMs do not have to be of Caribbean or Sub-Saharan background
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse (as defined by a worsening of symptoms lasting over two weeks, a Cochrane recommended measure) assessed using case-notes/medical records (service users only) throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/10/2021: At baseline, after 10th session (intervention) or 26 weeks (control), 6 months, and 12 months: 1. Number of psychiatric and compulsory admissions (service users) measured using patient records 2. Length of inpatient stays (service users) measured using patient records 3. Positive, negative, and general symptoms measured using the Positive and Negative Syndrome Scale (PANSS) (service users) 4. Social functioning measured using the Personal and Social Performance Scale (PSP) (service users) 5. Illness perceptions measured using the Brief Illness Perception Questionnaire (Brief-IPQ) (service users and family members/FSMs) 6. Knowledge about psychosis measured using the Culturally-adapted Knowledge about Psychosis Questionnaire 7. Emotional distress measured using the General Health Questionnaire (GHQ-12) (family members/FSMs) 8. Health status and quality of life measured using the EQ5D-5L (service users and family members/FSMs) 9. Quality of staff-service user relationships measured using the Working Alliance Inventory (WAI) (service users and therapists/key workers) 10. Service engagement of service users measured using the Service Engagement Scale (SES) _____ Previous secondary outcome measures: At baseline, after 10th session (intervention) or 20-weeks (control), 6 months, and 12 months: 1. Number of psychiatric and compulsory admissions (service users) measured using patient records 2. Length of inpatient stays (service users) measured using patient records 3. Perceived coercion (service users) measured using 4. Positive, negative, and general symptoms measured using the Positive and Negative Syndrome Scale (PANSS) (service users) 5. Social functioning measured using the Personal and Social Performance Scale (PSP) (service users) 6. Illness perceptions measured using the Brief Illness Perception Questionnaire (Brief-IPQ) (service users and family members/FSMs) 7. Knowledge about psychosis measured using the | — |
Countries
England, United Kingdom
Contacts
Public ContactTrial Manager
Outcome results
None listed