Condition category
Mental and Behavioural Disorders
Date applied
06/10/2010
Date assigned
25/11/2010
Last edited
29/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Mike Slade

ORCID ID

Contact details

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

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

http://www.kcl.ac.uk/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes

29/01/2016: Internal review.