REFOCUS Randomised Controlled Trial (RCT)

ISRCTN	ISRCTN02507940
DOI	https://doi.org/10.1186/ISRCTN02507940
Secondary identifying numbers	10/H0807/4

Submission date: 06/10/2010
Registration date: 25/11/2010
Last edited: 29/01/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Mike Slade
Scientific

Refocus Programme, Recovery Section
Health Service and Population Research Department
Institute of Psychiatry at King's College London
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Study information

Study design	Cluster multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	REFOCUS: a cluster randomised controlled trial of recovery interventions within community based mental health teams
Study acronym	REFOCUS RCT
Study objectives	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(s)	East London REC 3, 22/02/2011, ref: 11/LO/0083
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	18/04/2011
Completion date	31/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	420
Key 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
Key exclusion criteria	1. Currently receiving in-patient care 2. Does not speak and/or understand English
Date of first enrolment	18/04/2011
Date of final enrolment	31/08/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Psychiatry at King's College London

London
SE5 8AF
United Kingdom

Sponsor information

King's College London (KCL)
University/education

SLaM/IoP R&D Office
Institute of Psychiatry at King's College London
De Crespigny Park
Denmark Hill
London
SE5 8AF
England
United Kingdom

Website	http://www.kcl.ac.uk/
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Government

National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) programme (ref: 10/H0807/4)

No information available

Results and Publications

Intention to publish date	30/06/2014
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a peer reviewed journal.
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	23/11/2011	Yes	No
Results article	results	29/05/2014	Yes	No
Results article	results	01/06/2015	Yes	No

Editorial Notes

29/01/2016: Internal review.