SuicideNCT03499548
The INSPiRe Programme: Developing an Intensive Suicide Prevention Therapy for Suicidal Prisoners
A study testing INSPiRe Programme in people with Suicide, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Suicide
- What is being tested?
- INSPiRe Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2018to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
HMP Risley
Warrington, Greater Manchester, WA3 6BP
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide
- Being tested
- INSPiRe Programme
- Keywords
- Intensive, Cognitive Behavioral Therapy, Male prisoners
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSPiRe ProgrammeOther
Intensive CBT for suicide
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: INSPiRe Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Client Satisfaction Questionnaire (CSQ-8)
A measure of participant satisfaction with therapy
Measured: 20 minutes
Therapist Session Summary
Measuring levels of adherence and engagement
Measured: 5 minutes
Discharge summary sheet
Capturing individuals' adherence to the programme or discharge from it
Measured: 15 minutes
Therapist Rating Form
Giving an overall picture of each individual's engagement and progress during the study.
Measured: 20 minutes
Post-intervention interview
Qualitative interview to explore the participant's experience of therapy
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Jun 2018
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Killilea, University of Manchester
- Investigators
- Daniel Pratt, Principal investigator, University of ManchesterYvonne Awenat, Study chair, University of ManchesterCharlotte Lennox, Study chair, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499548
- Sponsor's protocol ID
- 238927
- Status last verified
- Aug 2019
- First submitted
- 19 Mar 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INSPiRe Programme: A Feasibility and Acceptability Study of Intensive Suicide Prevention Therapy in Prison
- ClinicalTrials.gov ID
- NCT03499548
- Acronym / sponsor ID
- 238927
- Conditions
- Suicide
- Keywords
- Intensive, Cognitive Behavioral Therapy, Male prisoners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: INSPiRe Programme10 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INSPiRe ProgrammeIntensive CBT for suicide | Other | Intervention |
Primary outcome
The Client Satisfaction Questionnaire (CSQ-8)
Time frame: 20 minutes
A measure of participant satisfaction with therapy
Therapist Session Summary
Time frame: 5 minutes
Measuring levels of adherence and engagement
Discharge summary sheet
Time frame: 15 minutes
Capturing individuals' adherence to the programme or discharge from it
Therapist Rating Form
Time frame: 20 minutes
Giving an overall picture of each individual's engagement and progress during the study.
Post-intervention interview
Time frame: 1 hour
Qualitative interview to explore the participant's experience of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Pratt principal investigator
University of Manchester
Yvonne Awenat study chair
University of Manchester
Charlotte Lennox study chair
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSPiRe Programme in people with Suicide, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Client Satisfaction Questionnaire (CSQ-8) (time frame: 20 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.