Condition category
Mental and Behavioural Disorders
Date applied
10/10/2012
Date assigned
11/10/2012
Last edited
09/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Crisis resolution teams (CRTs) are specialised teams that provide rapid assessment and treatments to people having a mental health crisis. CRTs were introduced in the UK in 2001 in order to improve experiences for people suffering a mental health crisis (sudden breakdown) and to limit the amount of people who were admitted to hospital. Although there have been positive effects of implementing CRTs such as reducing inpatient admissions and lowing healthcare costs, many service users reported issues in the long term, such as continuity of care between services during and following a period of CRT care. The aim of this study is to find out whether working through a self-management workbook with support when leaving CRTs could help to promote recovery and reduce the risk of further episodes (relapse).

Who can participate?
Adults who have been on the caseload of a participating CRT for at least a week.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are offered up to 10 meetings with a peer support worker over a course of four months, who helps them to work through a self-management workbook. The workbook is made up of structured sections, helping the participant to set personal recovery goals, re-establishing their social support network, advice to help prevent the crisis happening again, and planning strategies and coping resources for when the crisis is resolved. Those in the second group are also given the self-management workbook to complete but are given no additional guidance about how to use it. At the start of the study and then after 4 months, participants are interviewed in order to assess how well they are coping. One year after the start of the study, the participants medical records are also reviewed in order to find out about how much they have used mental health services and if they have been admitted to hospital. An additional follow up interview will be completed with participants 18 months after study entry.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
February 2014 to April 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Brynmor Lloyd-Evans
b.lloyd-evans@ucl.ac.uk

Trial website

http://www.ucl.ac.uk/core-study

Contact information

Type

Scientific

Primary contact

Dr Brynmor Lloyd-Evans

ORCID ID

Contact details

Division of Psychiatry
6th Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 20 7679 9428
b.lloyd-evans@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15999

Study information

Scientific title

Optimising team functioning, preventing relapse and enhancing recovery in Crisis Resolution Teams (CRTs): the CORE Programme (Crisis team Optimisation and RElapse prevention) Phase 3: Randomised controlled trial of a peer provided, self-management intervention for people leaving CRT services

Acronym

CORE Phase 3

Study hypothesis

Current hypothesis as of 05/02/2014:
1. Provision of a peer-provided, self-management programme for people leaving Crisis Resolution Teams will reduce readmission to acute care over one year follow-up.
2. Provision of a peer supported, self-management programme for people leaving Crisis Resolution Teams will improve satisfaction with services, self-rated recovery, illness management, social inclusion , symptoms and loneliness, social support and neighbourhood social capital at follow-up post-treament and at 18-month follow-up, and reduce inpatient bed use over one year follow-up.

Previous hypothesis:
1. Provision of a peer-provided, self-management programme for people leaving Crisis Resolution Teams will reduce readmission to acute care over one year follow-up.
2. Provision of a peer supported, self-management programme for people leaving Crisis Resolution Teams will improve satisfaction with services, self-rated recovery, illness management, employment, symptoms and perceived continuity of care at follow-up post-treament, and reduce inpatient bed use over one year follow-up.

Ethics approval

First MREC, 19/07/2012, ref: 12/LO/0988

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled 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

Mental Health Research

Intervention

Current interventions as of 05/02/2014:
Peer-provided self management
Participants in the treatment group will be offered up to 10 meetings with a peer support worker, who will support them in developing a personal recovery plan using a manualised workbook. Participants in the control group will be given the self-management workbook but no additional guidance or peer support to help use it.
Followed up by a research interview after 4 and 18 months and via patient records over 12 months

Previous interventions:
Peer-provided self management
Participants in the treatment group will be offered up to 10 meetings with a peer supprot worker, who will support them in developing a personal recovery plan using a manualised workbook.
Followed up after 6 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Re-admission to acute care measured at one year from study entry

Secondary outcome measures

Current secondary outcome measures as of 05/02/2014:
1. Days in acute care over 1-year follow-up
2. Time to readmission (1-year follow-up)
3. Mental health service use (1-year follow-up)
4. Illness management measured at 4-month follow-up interview - IMR questionnaire
5. Psychiatric symptoms measured at 4-month follow-up interview - BPRS questionnaire
6. Satisfaction with services measured at 4-month follow-up interview - CSQ questionnaire
7. Self-rated recovery measured at 4-month follow-up - QPR questionnaire
8. Social inclusion at 4-month follow-up – SIX questionnaire
9. Loneliness at 4-month follow-up – UCLA Loneliness Scale questionnaire
10. Social network at 4-month follow-up – Lubben SNS questionnaire
11. Neighbourhood social capital at 4-month follow-up - Health and Lifestyles survey Neighbourhood social capital questionnaire

Added 07/12/2016: Outcomes 4-11 will also be assessed at 18 month follow-up.

Previous secondary outcome measures:
1. Employment status measured at 4 month follow up interview
2. Illness Management measured at 4 month follow-up interview - IMR questionnaire
3. Inpatient bed days, measured one year following study entry
4. Perceived continuity of care, measured by Continu-um questionnaire at 4 month follow-up
5. Psychiatric symptoms measured at 4 month follow up interview - BPRS questionnaire
6. Satisfaction with services measured at 4 month follow-up interview - CSQ questionnaire
7. Self-rated recovery measured at 4 month follow up - QPR questionniare

Overall trial start date

01/04/2011

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 05/02/2014:
1. Adults (aged 18+) who have been on the caseload of a participating Crisis Resolution Team for at least a week
2. Male and female
3. A threshold has been set that at least half the participants recruited must be identified during screening at services as having schizophrenia or other psychosis or bipolar disorder

Previous inclusion criteria:
1. Adults (aged 18+) who have been on the caseload of a participating Crisis Resolution Team for at least a week
2. Male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 440

Participant exclusion criteria

Current exclusion criteria as of 05/02/2014:
1. People who lack capacity to consent to take part in the study
2. People who in the view of the clincal team at their Crisis Resolution Team present such a high risk of harm to others, it would be unsafe for researchers or peer support workers to meet with them even in a mental health service setting
3. People who are discharged to addresses outside the catchment area
4. People who cannot understand the intervention when delivered in English

Previous exclusion criteria:
1. People who lack capacity to consent to take part in the study
2. People who in the view of the clinical team at their Crisis Resolution Team present such a high risk of harm to others, it would be unsafe for researchers or peer support workers to meet with them even in a mental health service setting
3. People who are already on the caseloads of a highly intensive community service, such as an Assertive Outreach Team
4. People who are discharged to addresses outside the catchment area
5. People who cannot understand the intervention when delivered in English

Recruitment start date

06/02/2014

Recruitment end date

03/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
W1 7EJ
United Kingdom

Sponsor information

Organisation

Camden and Islington NHS Foundation Trust (UK)

Sponsor details

Research and Development Department
Bloomsbury Building
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.candi.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer-reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/12/2016: The overall trial start date has been updated from 06/02/2014 to 01/04/2011. In addition, the publication and dissemination plan and data sharing plan have been added. 07/12/2016: The outcome measures section has been updated. In addition the overall trial end date has been changed from 31/03/2016 to 30/04/2017 and the recruitment end date has been updated from 31/03/2016 to 03/07/2015. 21/03/2016: Plain English summary added. 05/02/2014: The following changes were made to the trial record 1. The anticipated start date was changed from 02/01/2014 to 06/02/2014 2. The target number of participants was changed from 445 to 440 Other changes are indicated in the corresponding fields.