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
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