- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499548
The INSPiRe Programme: Developing an Intensive Suicide Prevention Therapy for Suicidal Prisoners
August 9, 2019 updated by: Jessica Killilea, University of Manchester
The INSPiRe Programme: A Feasibility and Acceptability Study of Intensive Suicide Prevention Therapy in Prison
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Greater Manchester
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Warrington, Greater Manchester, United Kingdom, WA3 6BP
- HMP Risley
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
|
Intensive CBT for suicide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 20 minutes
|
A measure of participant satisfaction with therapy
|
20 minutes
|
Therapist Session Summary
Time Frame: 5 minutes
|
Measuring levels of adherence and engagement
|
5 minutes
|
Discharge summary sheet
Time Frame: 15 minutes
|
Capturing individuals' adherence to the programme or discharge from it
|
15 minutes
|
Therapist Rating Form
Time Frame: 20 minutes
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Giving an overall picture of each individual's engagement and progress during the study.
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20 minutes
|
Post-intervention interview
Time Frame: 1 hour
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Qualitative interview to explore the participant's experience of therapy
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Pratt, University of Manchester
- Study Chair: Yvonne Awenat, University of Manchester
- Study Chair: Charlotte Lennox, University of Manchester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
April 26, 2019
Study Completion (Actual)
April 26, 2019
Study Registration Dates
First Submitted
March 19, 2018
First Submitted That Met QC Criteria
April 13, 2018
First Posted (Actual)
April 17, 2018
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
August 9, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 238927
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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