Condition category
Mental and Behavioural Disorders
Date applied
28/10/2011
Date assigned
28/10/2011
Last edited
17/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The suicide rate in prisoners is five times greater than that found in the general community. Suicide is the leading cause of death in British prisons, yet it is preventable. Being in prison can lead people to experience fear, distrust, lack of control, feel isolated and ashamed. Prisoners can often find living in prison difficult to cope with and can feel overwhelmed and hopeless. This can lead some of them to choose suicide as a way to escape. The aim of this study is to see if we can provide our existing talking therapy, called Cognitive Behavioural Suicide Prevention (CBSP), to current prisoners thought to be at risk of suicide.

Who can participate
All participants will be current prisoners in a prison in the Northwest of England. You have to be male, over 18 years old, and currently, or in the past month, under the ACCT system. You also have to have a good grasp of the English language and be able to consent to take part.

What does the study involve?
After agreeing to take part in the study, participants will be randomly allocated to one of two groups. The first group will continue to receive their usual treatment, whilst the second group will also receive a talking therapy, CBSP. The CBSP intervention involves meeting with a therapist for up to 16 hourly sessions on individual therapy, usually on a weekly basis.

What are the possible benefits and risks of participating?
It is possible for some participants to become distressed during the study because of the nature of the research subject, which may involve talking about events, thoughts, feelings or issues related to suicide and other mental health problems. However, we have found that most people who take part in studies about suicide find it to be a positive experience. On a larger scale, we hope the results of this study will lead to larger studies across a number of prisons providing therapy to many suicidal prisoners.

Where is the study run from?
This study is being run in a prison in the Northwest of England.

When is the study starting and how long is it expected to run for?
The study started in October 2011 and is expected to take until November 2013, although recruitment of new participants ends in April 2013.

Who is funding the study?
The study is being funded by the National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme.

Who is the main contact?
Daniel Pratt
daniel.pratt@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Pratt

ORCID ID

Contact details

Zochonis Building
Brunswick Street
Oxford Road
Manchester
M13 9PL
United Kingdom
-
daniel.pratt@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8945

Study information

Scientific title

Feasibility Study of a Cognitive Behavioural Suicide Prevention Intervention for Male Prisoners WP1

Acronym

CBSP for Prisoners 1

Study hypothesis

The aim of this study is to demonstrate the feasibility of delivering our existing Cognitive Behavioural Suicide Prevention (CBSP) intervention in a prison environment. We will also investigate how best to adapt the delivery of CBSP for prisoners. To address these aims, Work Package 1 will be a randomised controlled trial (RCT) with 30 prisoners at risk of suicidal behaviour receiving CBSP plus usual treatment. Another 30 prisoners, also at risk, will receive their usual treatment alone. The RCT will be nested within Work Package 2, which will inform and subsequently assess the delivery of CBSP to prisoners. Prisoner interviews and a staff focus group will examine views on how CBSP should be modified for the prison environment. Work Package 3 will be a 6-month follow-up study of the longer-term impact of the intervention.

Ethics approval

Research Ethics Committee for Wales, 09/03/2011, ref: 11/WA/0002MHRN1

Study design

Randomised; Interventional; Design type: Treatment

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

Topic: Mental Health Research Network; Subtopic: Suicide and self-harm; Disease: Suicide and self harm

Intervention

CBSP, Cognitive Behaviour Suicide Prevention - a new talking therapy targetting the prevention of suicidal behaviour; Study Entry : Single Randomisation only

To help identify and care for prisoners at risk of suicidal behaviour, HM Prison Service uses a care-planning system called ACCT (Assessment, Care in Custody, and Teamwork). On any one day, over 1,500 prisoners are identified under the ACCT system (MoJ, 2009). The ACCT system offers assessment, monitoring and generic counselling to at-risk prisoners. In this study, we will randomly allocate prisoner participants who have been identified by staff as at risk of suicidal behaviour to receive the Cognitive Behavioural Suicide Prevention (CBSP) intervention plus ACCT, or to receive ACCT alone.

The CBSP intervention draws from established Cognitive Behavioural techniques to restructure three aspects of the our psychological model of suicidal behaviour: (i) information processing biases, (ii) appraisals, and (iii) suicide schema. The intervention also includes sessions of unstructured supportive counselling to develop pragmatic strategies to insure against social isolation as part of a recovery process from suicidality. From clinical experience, CBSP involves up to 16 hourly sessions of individual therapy. These are preliminary guidelines and further elaboration may be required of the treatment parameters for the prisoner population and custodial setting.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The number of episodes of suicidal behaviour in the past 6 months; Timepoint(s): baseline and 6 months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2011

Overall trial end date

30/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. Aged 18 years and over
3. Identified by HM Prison Service as at risk of suicidal behaviour
4. Expected to be located within the host prison for the next 12 months
5. Thorough grasp of the English language
6. Have the mental capacity to consent to research; Target Gender: Male ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 90; UK Sample Size: 90

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2011

Recruitment end date

01/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0609-19126

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26165919

Publication citations

Additional files

Editorial Notes