Condition category
Mental and Behavioural Disorders
Date applied
20/09/2012
Date assigned
20/09/2012
Last edited
06/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Critical Time Intervention (CTI), a case management model, was originally developed in New York to reduce homelessness amongst those discharged from hospital suffering from a mental illness. CTI is intensive case management at times of transition, e.g. between prison and the community. In 2007, CTI was adapted for mentally ill prisoners due to be released and a study was conducted to see if CTI effectively connected these prisoners with social, clinical, housing and welfare services in the first few weeks after leaving prison. Results suggested continuity of care for prisoners with severe mental illness can be improved by working with them to identify needs prior to release, and by assisting them to engage effectively with the necessary community agencies. The main aims of this study are to establish whether a specific model of case management, Critical Time Intervention (CTI), is effective in improving engagement with health and social care services, reducing mental health hospital admissions, reducing re-offending, and reducing time in prison among released adult male prisoners with severe and enduring mental illness (SMI).

Who can participate?
Adult male prisoners due for release, with severe and enduring mental illness, who are receiving secondary mental health care in prison.

What does the study involve?
The case management model Critical Time Intervention (CTI) will be compared to treatment as usual (TAU) for prisoners with mental health problems due for release. Participants will be randomly allocated to either the CTI or TAU group.

What are the possible benefits and risks of participating?
If allocated to receive CTI, participants may receive extra support upon that normally provided in the treatment as usual condition, i.e. having a case manager that follows them into the community after release.

Where is the study run from?
HM Prisons Manchester, Leeds and Brixton are the research sites. The Principal Investigator is based at the University of Manchester (UK).

When is the study starting and how long is it expected to run for?
The study began in January 2012 and will run until June 2015. Recruitment will run for 18 months from September 2012.

Who is funding the study?
The National Institute for Health Research: Service Delivery and Organisation Programme (UK).

Who is the main contact?
Prof. Jenny Shaw
Jennifer.j.shaw@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Caroline Stevenson

ORCID ID

Contact details

Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 275 8146
caroline.stevenson@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11664

Study information

Scientific title

Critical time Intervention for Severely mentally ill released Prisoners: A randomised control trial

Acronym

CrISP

Study hypothesis

The primary aims of the project are to establish whether a specific model of case management, Critical Time Intervention, is effective in:
1. Improving engagement with health and social care services upon discharge from prison
2. Reducing mental health in-patient episodes
3. Reducing re-offending
4. Increasing community tenure through reducing time in institutional settings among released adult male prisoners with severe and enduring mental illness.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11664

Ethics approval

Research Ethics Committee for Wales, 16/01/2012, ref: 11/WA/0328

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Service Delivery; Disease: Severe Mental illness

Intervention

1. Treatment as usual

2. Critical Time Intervention is a comprehensive case management model, focusing on physical care, mental health, substance misuse, accommodation, financial and social support needs.

Follow Up Length: 12 month(s)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Engagement post discharge at 6 weeks

Secondary outcome measures

1. Engagement with mental health services at six, 12 and 18 months post-randomisation
2. Number of days in hospital, including any detention under the Mental Health Act; and CJS contact and re-conviction rates, comparing data from 12 months before the recent period of imprisonment with the 12 months post-randomisation, using the Police National Computer (PNC). Community tenure will be calculated by adding the number of days in hospital to days in prison.
3. The unit cost of the new service, costs of service use and estimated costs of crime will be compared between the CTI and TAU groups.

Overall trial start date

01/10/2012

Overall trial end date

28/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. Have severe and enduring mental illness (defined as major depressive disorder, hypomania, bipolar disorder and/or any form of psychosis including schizophrenia, schizoaffective disorder and any other non-affective, non-organic psychosis)
3. Be a client of Inreach services
4. Have a release/likely release date within 6 months of randomisation to the study
5. Have at least 4 weeks left in prison after randomisation to the study

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200; Description: 100 Critical Time Intervention 100 Treatment as Usual

Participant exclusion criteria

Those who do not have the capacity to consent will be excluded from the study. Arguably, these are possibly the most vulnerable prisoners with mental health problems. The research team acknowledge this potential limitation however for those individuals who do lack capacity to consent most (if not all) will be in the process of being transfered to NHS secure services or are very unlikely to be released directly into the community and therefore would not be eligible for the study given the inclusion criteria.

Recruitment start date

01/10/2012

Recruitment end date

28/02/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Jean McFarlane Building
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Faculty Research Support Services
Faculty of Medical and Human Sciences
Simon Building
Brunswick Street
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Service Delivery Organisation; Grant Codes: SDO 09/1004/15

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/09/2016: No publications found in PubMed, verifying study status with principal investigator.