Condition category
Mental and Behavioural Disorders
Date applied
03/02/2016
Date assigned
04/02/2016
Last edited
08/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Mental health problems are very common in prisoners, both while in prison and following release. It has been found that more than half have a mental health problem of some kind, with many having two or more. While prison healthcare has improved in recent years, mental healthcare is minimal for many and care after leaving prison is particularly lacking for those with short sentences. Addressing prisoners’ mental health problems could lead to considerable improvements to their health, the wellbeing of their families and communities, improved social inclusion, reduced reoffending, and associated financial benefits to society. The Engager collaborative care programme was developed to help prisoners with common mental health problems (such as anxiety, depression and post-traumatic stress disorder) near to and after their release. The aim of this study is assess the effectiveness of the Engager programme at helping men with common mental health problems as they approach being released from prison.

Who can participate?
Men with a prison sentence of two years or less with between 4 and 20 weeks left to serve, who currently have mental health problems, or are likely to have such problems following release.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group begin the Engager programme up to 16 weeks before they are due to be released from prison and for up to 12 weeks after their release. This involves working closely with an Engager practitioner in order to set goals and help the participants to connect with services in the community that can help them to achieve these goals. Those in the second group receive usual care for the remainder of their prison stay and when they are released. At the start of the study and then 1 week before release and 1, 3 and 6 months after release, participants complete a number of questionnaires in order to assess their mental health and where they are in life. Twelve months after release, participants are followed up so that the amount that have been sent back to prison can be recorded.

What are the possible benefits and risks of participating?
Participants could potentially benefit from being able to manage anxieties and mood more effectively and improve contact with services after release from prison. There are no significant risks of taking part, although some participants may find it distressing to think and talk about their past experiences.

Where is the study run from?
Two prisons and communities in the South West and one in the North West of England (UK)

When is the study starting and how long is it expected to run for?
December 2015 to December 2018

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

Who is the main contact?
Dr Tim Kirkpatrick
tim.kirkpatrick@plymouth.ac.uk

Trial website

http://www1.plymouth.ac.uk/research/engager/Pages/default.aspx

Contact information

Type

Public

Primary contact

Dr Tim Kirkpatrick

ORCID ID

Contact details

International Teaching and Training Centre
N32
I T T C Building
1 Tamar Science Park
Davy Road
Plymouth
PL6 8BX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20205

Study information

Scientific title

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release -­ Full Trial

Acronym

Study hypothesis

The aim of this study is to assess the effectiveness and cost effectiveness of the Engager intervention in addressing the well-being and unmet needs of offenders with common mental health problems who are serving short sentences.

Ethics approval

Wales REC 3, 12/10/2015, ref: 15/WA/0314

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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; Subtopic: All Diagnoses; Disease: Not Applicable

Intervention

In the first phase of this study, a collaborative care intervention (Engager intervention) for prisoners with common mental health problems, near to and after release was developed. This study will look at the effectiveness of the Engager Intervention. The intervention aims to overcome a set of challenges that have been identified as being problematic for this group including:
1. Transition between prison and community
2. Fragmented services based on diagnosis (e.g. substance misuse, depression) and social problems (homelessness, unemployment) rather than the reality of people with multiple and complex needs
3. Offenders’ reluctance to trust services (or see themselves as having mental health problems)

Participants are randomly allocated to one of two groups.

Group 1: Participants receive the Engager intervention following release from prison. The intervention is designed to engage with individuals with common mental health problems who are close to release and to set up on a pathway of care from 16 weeks pre-release (in preparation for discharge) and for up to 12 weeks out in the community. The intervention will be delivered by practitioners supported by a supervisor. They will be working with offenders both pre and post-release. This work will include:
1. Developing a shared understanding between the practitioner and the offender and producing a plan for achieving individualised goals
2. Actively liaising with relevant services to support need based on a shared plan
3. Working with offenders in preparation for the ending of support
4. A senior mental health worker with experience of therapeutic work will support our Engager Practitioners

Group 2: Participants receive standard care following release from prison.

The total length of the intervention varies, depending on how long they are in prison (between 4 and 16 weeks). The length of the community element of the intervention is flexible depending on the needs of individual participants, but is likely to be between 2 and 5 months. The maximum time any individual will receive the intervention is 9 months. Baseline assessments will be conducted at recruitment, and follow-up interviews will be collected at 1 week pre-release, and then at approximately 1, 3, and 6 months post release. Reconviction data will be collected at 12 months post-release.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Pychological distress is measured using the CORE-OM at baseline, 3 and 6 months post release.

Secondary outcome measures

1. Recidivism based on data from the Police National Computer (PNC) at 12 months post release
2. Assessment of subjective met and unmet need is measured using the Camberwell Assessment of Need – Forensic Version (CAN-FOR) - Adapted at baseline, 3 and 6 months post release
3. Change in objective social domains (accommodation, education, employment and benefits) is measured through interviews at baseline, 3 and 6 months post release
4. Service utilisation and helpfulness of services is measured using the Client Service Receipt Inventory (CSRI) - Adapted at baseline, 3 and 6 months post release
5. Health related quality of life… is measured using the EQ-5D-5L at baseline, 3 and 6 months post release
6. Well-being related quality of life is measured using the ICE-CAP-A at baseline, 3 and 6 months post release
7. Experience of care is measured using the Inspire questionnaire (Relationship section only) at baseline, 3 and 6 months post release
8. Drug and alcohol subjective dependence is measured using the Leeds Dependence Questionnaire at baseline, 3 and 6 months post release
9. Participant derived problems is measured using the PSYCHLOPS at baseline, 3 and 6 months post release
10. Hope, trust and motivation is measured using the Intermediate Outcomes Measurement Instrument (IOMI) at baseline, 3 and 6 months post release
11. Drug and alcohol use is measured using the Treatment Outcomes Profile - Adapted at baseline, 3 and 6 months post release

Overall trial start date

01/08/2013

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men with prison sentence of two years or less
2. Have between 20 and 4 weeks remaining to serve
3. Be identified using screening instruments as having, or likely to have following release, common mental health problems (e.g. depression, anxiety, PTSD)
4. Be willing to engage with treatment services and research procedures
5. Released to the geographical area of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 280; UK Sample Size: 280

Participant exclusion criteria

1. Prisoners on remand
2. Women (numbers are smaller and resettlement needs are different; research procedures developed are not feasible for this context)
3. Have a serious and enduring mental disorder and/or under the prison in-reach team
4. Those with active suicidal intent requiring management under the safer custody process or prison in-reach team, and where the healthcare team managing the prisoner feel it would be detrimental
NOTE: Once risk levels reduce individuals in this group will be eligible if not excluded for another reason
5. Have a primary personality disorder who are on the caseload of the Offender Personality Disorder Pathway programme
6. Present a serious risk of harm to the researchers or intervention practitioners
NOTE: Co-morbid substance misuse and personality disorder are NOT exclusion criteria

Recruitment start date

14/01/2016

Recruitment end date

31/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Plymouth University Schools of Medicine and Dentistry
N9 ITTC Building Plymouth Science Park Davy Road
Plymouth
PL6 8BX
United Kingdom

Trial participating centre

University of Manchester
Centre for Mental Health and Safety Institute of Brain, Behaviour and Mental Health 2.315, Jean McFarlane Building Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

Devon Partnership NHS Trust

Sponsor details

Wonford House
Dryden Road
Exeter
EX2 5AF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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 of study results in peer review journals and in a report to National Institute for Health Research.

Intention to publish date

30/06/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/02/2016: Verified study status with principal investigator.