Plain English Summary
Background and study aims
Approximately 1 in 100 people will experience mental health problems at some point in their lives. Psychotic disorders are a generalised term that describes a range of serious mental health problems, in which the sufferer loses touch with reality. The two main symptoms of psychotic disorders are delusions (unshakable beliefs in something that is not true) and hallucinations (seeing or hearing something that does not exist). These problems can be very upsetting for the sufferer and may cause them to become so anxious that they find it hard to cope with day-to-day life. Helping people suffering from these illnesses is one of the most important parts of mental health care. The REFOCUS programme is a specially designed training course which aims to help promote individual recovery from psychotic disorders. The aim of this study is to test the effectiveness of the programme in treating people with psychotic illnesses in the community.
Who can participate?
Adults suffering from a psychotic disorder and are being treated as an outpatient, and staff working in community mental health care teams in South London and Maudsley NHS Foundation Trust (SLaM) and2gether Partnership NHS Foundation Trust in Gloucestershire.
What does the study involve?
Mental health care teams are randomly allocated to one of two groups. Those in the first group take part in the 12 month REFOCUS program. The program is made up of training to help patients to take a more active role in their recovery and training to improve understanding about the best way to work with individual patients, such as setting personalised goals, focusing on a patient’s strengths to support recovery. Those in the second group continue as usual for the 12 months of the study. At the start of the study and then again after 12 months, staff complete a number of questionnaires to test their knowledge and attitudes towards patients with a mental illness. Patients (service users) also complete a number of questionnaires at the same times in order to test how well they feel their recovery is going and to assess their mental wellbeing.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The study takes place in two Mental Health Trusts: South London and Maudsley NHS Foundation Trust (SLaM) and2gether Partnership NHS Foundation Trust in Gloucestershire.
When is the study starting and how long is it expected to run for?
April 2011 to August 2013
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Mike Slade
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10/H0807/4
Study information
Scientific title
REFOCUS: a cluster randomised controlled trial of recovery interventions within community based mental health teams
Acronym
REFOCUS RCT
Study hypothesis
The personal recovery (Questionnaire about the Process of Recovery [QPR] scores) of service users receiving care from the recovery intervention teams will be significantly higher than the QPR scores of service users receiving care from the standard care teams.
Please note, as of 09/08/2011 the intervention for this trial has been reduced from 18 months to 12 months. Updates can be found under this date in the relevant fields below.
Ethics approval
East London REC 3, 22/02/2011, ref: 11/LO/0083
Study design
Cluster multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Psychosis
Intervention
The intervention teams will receive personal recovery intervention. The intervention comprises an 12-month (updated 09/08/2011; 18-month at time of registration) team-level pro-recovery intervention in addition to standard care. The intervention involves two components:
1. Recovery-promoting relationships
2. Pro-recovery working practices
The control teams will receive treatment as usual.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Questionnaire about the Process of Recovery (QPR), measured at baseline and 12 months post-baseline (updated 09/08/2011; 18 months at time of registration)
Secondary outcome measures
Staff-rated measures (updated 09/08/2011; 18 months post-baseline measurements at time of registration):
1. Recovery Knowledge Inventory (RKI) - a 20-item staff-rated measure of staff knowledge and attitudes about recovery, measured at baseline and 12 months post-baseline
2. Mental Illness: Clinicians' Attitudes (MICA) Scale - a 16-item of attitudes towards mental illness, measured at baseline and 12 months post-baseline
3. Health of the Nation Outcome Scale (HoNOS) is a 12-item staff-rated measure of social disability, measured at baseline and 12 months post-baseline
4. Camberwell Assessment of Needs Short Appraisal Schedule (CANSAS-S) assesses social and health needs over 22 domains, staff rated, measured at baseline and 12 months post-baseline
5. Mental Health Confidence Scale (MHCS) is a 16 item measure of self-efficacy, optimism, advocacy, measured at baseline and 12 months post-baseline
6. Herth Hope Index (HHI) is a 12-item service user-rated measure of client levels of hope, measured at baseline and 12 months post-baseline
7. Manchester Short Assessment of Quality of Life (MANSA) a 16-item measure, measured at baseline and 12 months post-baseline
8. Goal Attainment Scale (GAS)/Preferred Personal Outcomes(PPO) - individualised approach to measuring recovery, measured at baseline and 12 months post-baseline
9. Client Satisfaction Questionnaire8 (CSQ8) is an 8 item measure of client satisfaction with mental health services, measured at baseline and 12 months post-baseline
10. Camberwell Assessment of Needs Short Appraisal Schedule (CANSAS-SU) assesses social and health needs over 22 domains, service user rated, measured at baseline and 12 months post-baseline
11. The Importance of services in recovery - TEAM (INSPIRE-worker) is new measure of recovery orientation of services, measured at baseline and 12 months post-baseline
12. National Adult Reading Test (NART) is measure of pre-morbid level of intellectual functioning, measured at baseline and 12 months post-baseline
13. Brief Psychiatric Rating Scale (BPRS) is an 18-item observer-rated measure of symptomatology which is completed with the service user, measured at baseline and 12 months post-baseline
14. Client Service Receipt Inventory (CSRI) is a tool for collecting cost-related information about people with mental health problems for use in mental health service evaluations, measured at baseline and 12 months post-baseline
15. ICECAP-A - A measure of adult capability
16. The Global Assessment of Functioning (GAF) is a 3-item staff rated measure of impairment in functioning
Overall trial start date
18/04/2011
Overall trial end date
31/08/2013
Reason abandoned
Eligibility
Participant inclusion criteria
Service user criteria:
1. Aged 16 - 65 years, either sex
2. Primary clinical diagnosis of psychosis, e.g. schizophrenia, schizo-affective disorder, bipolar disorder
3. Expectation that service user will be in contact with team for 18 months
4. Not currently receiving in-patient care
5. Speaks and understands English
6. In opinion of clinician, is sufficiently well to participate
Team inclusion criteria:
1. Community-based mental health team with the SLaM Psychosis Clinical Academic Group (CAG) or any in2gether
2. Provide a care co-ordinating function
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
420
Participant exclusion criteria
1. Currently receiving in-patient care
2. Does not speak and/or understand English
Recruitment start date
18/04/2011
Recruitment end date
31/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Psychiatry at King's College London
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (KCL)
Sponsor details
SLaM/IoP R&D Office
Institute of Psychiatry at King's College London
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) programme (ref: 10/H0807/4)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
30/06/2014
Participant level data
Not expected to be available
Results - basic reporting
Publication summary
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22112008
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24875748
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26360446
Publication citations
-
Protocol
Slade M, Bird V, Le Boutillier C, Williams J, McCrone P, Leamy M, REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams., BMC Psychiatry, 2011, 11, 185, doi: 10.1186/1471-244X-11-185.
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Results
Leamy M, Clarke E, Le Boutillier C, Bird V, Janosik M, Sabas K, Riley G, Williams J, Slade M, Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial., PLoS ONE, 2014, 9, 5, e97091, doi: 10.1371/journal.pone.0097091.
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Results
Slade M, Bird V, Clarke E, Le Boutillier C, McCrone P, Macpherson R, Pesola F, Wallace G, Williams J, Leamy M, Supporting recovery in patients with psychosis through care by community-based adult mental health teams (REFOCUS): a multisite, cluster, randomised, controlled trial, Lancet Psychiatry, 2015 , 2, 6, 503-514, doi: 10.1016/S2215-0366(15)00086-3.