Plain English Summary
Background and study aims
Schizophrenia is a severe long-term mental health condition. It causes a range of different psychological symptoms. Doctors often describe schizophrenia as a type of psychosis. This means the person may not always be able to distinguish their own thoughts and ideas from reality. Around 15 people per 100,000 are diagnosed with schizophrenia in England every year. Black people are much more likely to receive this diagnosis than other ethnic groups. They have longer periods without receiving treatment. This can increase stress and family conflict. Family Intervention (FI) is a ‘talking treatment’ that helps reduce conflict. Service users receiving FI stay well longer. NICE recommends FI for families affected by schizophrenia. However, Black families are less likely than others to be offered talking treatments.
Previously, the researchers worked with Caribbean families, community members, and healthcare professionals to develop a culturally-appropriate FI. It was called ‘Culturally-adapted FI’ - ‘CaFI’ for short. We changed an existing FI to make it ‘less White’, including how things like racism and spiritual beliefs affect people’s experiences of schizophrenia. People liked CaFI. Of 26 family units that started CaFI, 24 completed all 10 sessions. CaFI therapists also liked it. Service users, therapists and families all said that CaFI should become available to everyone, especially African people.
This study will test CaFI compared to usual care with people from Sub-Saharan African/Caribbean/Mixed backgrounds.
Who can participate?
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’, diagnosed with schizophrenia or related diagnoses.
What does the study involve?
Each service user and their family will have a 50% chance of receiving CaFI. The other 50% will continue with their usual care. All participants will complete questionnaire assessments and interviews at four time-points in the study.
What are the possible benefits and risks of participating?
Benefits:
The feasibility pilot study of CaFI showed that service users, relatives/carers, and (service user-nominated) FSMs reported positive service user benefits, including improved symptoms (better mood, less paranoia), improved social functioning, and active planning to return to work and fulltime education. Therapeutic alliance was positively rated by all groups. Improved communication between service users, families, and health professionals was also reported. We expect participants to experience similar benefits as part of this multi-site trial, including a reduced risk of relapse.
Risk:
There is a risk that some participants may become distressed when reflecting on personal experiences of living with mental illness and its impact on family relationships.
Where is the study run from?
7 NHS Trusts in Northwest, Midlands, London, and South West England
When is the study starting and how long is it expected to run for?
April 2020 to February 2023
Who is funding the study?
National Institute for Health Research (NIHR), UK
Who is the main contact?
Helen Wilson (scientific)
Helen.Wilson@gmmh.nhs.uk
Prof. Dawn Edge (scientific)
dawn.edge@manchester.ac.uk
Jamal Alston (public)
jamal.alston@gmmh.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Helen Wilson
ORCID ID
Contact details
CaFI Office
3rd Floor Rawnsley Building
Hathersage Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 5272
Helen.Wilson@gmmh.nhs.uk
Type
Scientific
Additional contact
Prof Dawn Edge
ORCID ID
Contact details
Coupland I
University of Manchester
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 275 2570
dawn.edge@manchester.ac.uk
Type
Public
Additional contact
Mr Jamal Alston
ORCID ID
Contact details
CaFI Office
3rd Floor Rawnsley Building
Hathersage Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 276 5272
jamal.alston@gmmh.nhs.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 44117, IRAS 266123
Study information
Scientific title
The effect on relapse of Culturally-adapted Family Intervention (CaFI) compared to usual care among African and Caribbean people diagnosed with psychosis in the UK: a randomised controlled trial
Acronym
Study hypothesis
The Culturally-adapted Family Intervention (CaFI) therapy is more effective than usual care (e.g. other psychological therapies) and better value for money for African and Caribbean people diagnosed with schizophrenia in the United Kingdom.
Ethics approval
Approval pending, South Central – Hampshire B REC (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; 0207 104 8057; nrescommittee.southcentral-hampshireb@nhs.net), ref 19/SC/0607
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Schizophrenia, schizotypal and delusional disorders
Intervention
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 African participants. The researchers will also implement a process evaluation to find out what will make it easier/harder for CaFI to be taken up by services. The trial will be ‘blind’, which means that RAs collecting the data will not know which group each participant has been allocated to. This is done to avoid bias in data collection.
Methodology & procedure: In the implementation phase, process evaluation data will be collected through the trial. The researchers will conduct semi-structured interviews at two different time points (3 and 9 months) with 30 members of staff (therapists, care coordinators, NHS senior leaders and service managers, commissioners) purposively sampled wing people over time will enable us to tap into their perceptions and experiences of the intervention, and what factors affect CaFI’s implementation in services. Interviews will be audio-recorded, transcribed verbatim, anonymised and analysed using Normalisation Process Theory (May & Finch, 2009).
Trained Clinical Study Officers (CSOs) and RAs will take informed consent and complete baseline assessments from participants in an initial meeting. An additional meeting will be arranged if this is not feasible. Parents/guardians of participants under the age of 16 will be present at consent taking. However, the assessments will be conducted confidentially 1-to-1 with all service users to eliminate the possibility of bias caused by parental/guardian presence during data collection.
Following baseline data collection, participants will be randomised into one of the two conditions: the intervention group (who will receive CaFI) or the control group (usual care). Intervention group participants will be asked to nominate relatives, carers, or Key Workers (or equivalent) to attend the CaFI sessions with them. Where this is not possible and participants cannot suggest alternatives, the researchers shall provide details of Family Support Members (FSMs) from whom they can choose someone to support them during therapy. Participants will attend 10 x 1h sessions within a 20-week window. Control participants will continue with usual care, and they will not have access to CaFI.
Post-intervention data will be collected within a month after each intervention participant has completed their 10th session. Control participants will be invited to complete data collection at the 20-week time-point from enrolling in the study (the therapy window). Follow-up data will be collected at 6 months and 12 months for both intervention and control participants. Thus, data will be collected at four time-points per participant.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
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 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 Knowledge about Psychosis Interview (KAPI) (family members/FSMs)
8. Knowledge about psychosis measured using the Culturally-adapted Knowledge about Psychosis Questionnaire
9. Emotional distress measured using the General Health Questionnaire (GHQ-12) (family members/FSMs)
10. Health status and quality of life measured using the EQ5D-5L (service users and family members/FSMs)
11. Quality of staff-service user relationships measured using the Working Alliance Inventory (WAI) (service users and therapists/key workers)
12. Service engagement of service users measured using the Service Engagement Scale (SES)
Overall trial start date
01/09/2017
Overall trial end date
30/09/2023
Reason abandoned (if study stopped)
Eligibility
Participant 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 to participate in therapy.
4. Assessed by Care Coordinators/key workers as not presenting a high, short-term risk to self or others
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 404; UK Sample Size: 404
Participant 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
Recruitment start date
01/04/2020
Recruitment end date
01/01/2022
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Prestwich Hospital
Greater Manchester Mental Health NHS Foundation Trust
Harrop House
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Trial participating centre
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
Trial participating centre
Healthy Minds Bury
Pennine Care NHS Foundation Trust
225 Old Street
Ashton-under-Lyne
OL6 7SR
United Kingdom
Trial participating centre
Mersey Care NHS Foundation Trust
V7 Building Kings Business Park
Prescot
Liverpool
L34 1PJ
United Kingdom
Trial participating centre
Queen Elizabeth Hospital Birmingham
University Hospitals Birmingham NHS Foundation Trust
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Trial participating centre
Coventry And Warwickshire Partnership NHS Trust
Wayside House
Coventry
CV6 6NY
United Kingdom
Trial participating centre
University of Warwick
Kirby Corner Rd
Coventry
CV4 7AL
United Kingdom
Trial participating centre
Tatchbury Mount Hospital
Calmore
Southampton
SO40 2RZ
United Kingdom
Trial participating centre
King's College London
Health Service & Population Research
De Crespigny Park
London
SE5 8AF
United Kingdom
Trial participating centre
Maudsley Hospital
South London and Maudsley NHS Foundation Trust
Denmark Hill
London
SE5 8AZ
United Kingdom
Sponsor information
Organisation
Greater Manchester West Mental Health NHS Foundation Trust
Sponsor details
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
+44 (0)161 2710076
sarah.leo@gmmh.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: HTA 16/167/76
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.
Repository: UK Data Archive/University of Manchester
When data will be made available: Six to twelve months after study conclusion.
What criteria for data to be shared, with whom: Future researchers.
Whether consent from participants is needed: Participants will have consented to the participant information sheet, which specifies that data will be freely available to the public on the UK Data Archive for ten years. It is stated that future researchers will be able to use their data.
Comments on data anonymisation: Participants will be allocated a study number. Personal identifiable data and participant study numbers will not be stored in the same location.
Ethical or legal restrictions: No patient identifiable data will be available.
Intention to publish date
01/02/2024
Participant level data
Stored in repository
Basic results (scientific)
Publication list