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The INSPiRe Programme: Developing an Intensive Suicide Prevention Therapy for Suicidal Prisoners

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
INSPiRe Programme
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Intensive, Cognitive Behavioral Therapy, Male prisoners

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged over 21 years old.
  • Has been managed under the Assessment, Care in Custody, and Teamwork (ACCT) system within the last 1 month (including current ACCT review).
  • Sufficient English language proficiency, as judged by the researcher, in order to complete psychometric questionnaires (i.e. adequate reading comprehension) and engage in intensive CBT programme (i.e. adequate verbal communication).
  • Adult is able to provide informed consent as established during baseline clinical interview (BPS, 2006; MCA, 2005).
  • Currently residing in HM Prison (and expected to remain there for at least six weeks; determined through staff and prisoner report).

Exclusion Criteria:

  • A primary organic disorder (indicated by prison medical staff report or records).
  • Any current risk behaviour which would compromise the safety of others, as identified by prison staff.

Sites / Locations

  • HMP Risley

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

10 hours of intensive CBT for suicide will be delivered to male prisoners who are having thoughts of ending their lives. This will be delivered in 2 hours sessions, 5 times across 2 weeks.

Outcomes

Primary Outcome Measures

The Client Satisfaction Questionnaire (CSQ-8)
A measure of participant satisfaction with therapy
Therapist Session Summary
Measuring levels of adherence and engagement
Discharge summary sheet
Capturing individuals' adherence to the programme or discharge from it
Therapist Rating Form
Giving an overall picture of each individual's engagement and progress during the study.
Post-intervention interview
Qualitative interview to explore the participant's experience of therapy

Secondary Outcome Measures

Full Information

First Posted
March 19, 2018
Last Updated
August 9, 2019
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT03499548
Brief Title
The INSPiRe Programme: Developing an Intensive Suicide Prevention Therapy for Suicidal Prisoners
Official Title
The INSPiRe Programme: A Feasibility and Acceptability Study of Intensive Suicide Prevention Therapy in Prison
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
April 26, 2019 (Actual)
Study Completion Date
April 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to assess the acceptability and feasibility of a short-term, intensive Cognitive Behavioural Therapy (CBT) delivered to male prisoners who have thoughts of ending their lives.
Detailed Description
10 hours of an adapted CBT therapy for suicide will be delivered across 2 weeks in 5 2 hour sessions to male prisoners. They will initially be assessed on several measures of mood, social support and suicidality. They will then undergo therapy. Following this they will be asked to re-completed the initial measures and a post-therapy interview to ascertain their thoughts on their experience of the therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Intensive, Cognitive Behavioral Therapy, Male prisoners

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
10 hours of intensive CBT for suicide will be delivered to male prisoners who are having thoughts of ending their lives. This will be delivered in 2 hours sessions, 5 times across 2 weeks.
Intervention Type
Other
Intervention Name(s)
INSPiRe Programme
Intervention Description
Intensive CBT for suicide
Primary Outcome Measure Information:
Title
The Client Satisfaction Questionnaire (CSQ-8)
Description
A measure of participant satisfaction with therapy
Time Frame
20 minutes
Title
Therapist Session Summary
Description
Measuring levels of adherence and engagement
Time Frame
5 minutes
Title
Discharge summary sheet
Description
Capturing individuals' adherence to the programme or discharge from it
Time Frame
15 minutes
Title
Therapist Rating Form
Description
Giving an overall picture of each individual's engagement and progress during the study.
Time Frame
20 minutes
Title
Post-intervention interview
Description
Qualitative interview to explore the participant's experience of therapy
Time Frame
1 hour

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
All participants will be recruited from a prison site that houses males.
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged over 21 years old. Has been managed under the Assessment, Care in Custody, and Teamwork (ACCT) system within the last 1 month (including current ACCT review). Sufficient English language proficiency, as judged by the researcher, in order to complete psychometric questionnaires (i.e. adequate reading comprehension) and engage in intensive CBT programme (i.e. adequate verbal communication). Adult is able to provide informed consent as established during baseline clinical interview (BPS, 2006; MCA, 2005). Currently residing in HM Prison (and expected to remain there for at least six weeks; determined through staff and prisoner report). Exclusion Criteria: A primary organic disorder (indicated by prison medical staff report or records). Any current risk behaviour which would compromise the safety of others, as identified by prison staff.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pratt
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yvonne Awenat
Organizational Affiliation
University of Manchester
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charlotte Lennox
Organizational Affiliation
University of Manchester
Official's Role
Study Chair
Facility Information:
Facility Name
HMP Risley
City
Warrington
State/Province
Greater Manchester
ZIP/Postal Code
WA3 6BP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The INSPiRe Programme: Developing an Intensive Suicide Prevention Therapy for Suicidal Prisoners

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