ClinicalTrials.gg
CompletedNCT03499548Updated Aug 12, 2019

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

An interventional study of INSPiRe Programme in Suicide, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to male participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-08-12.

Sponsored by University of Manchester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
21 Years and older
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Suicide

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Keywords

  • Intensive
  • Cognitive Behavioral Therapy
  • Male prisoners
03

In context

Suicide

607 studies on the registry are indexed under Suicide; 162 are open to participants now.

This study's enrollment of 13 is below the median of 104 across 490 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

University of Manchester is the lead sponsor of 201 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • 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.

    Other: INSPiRe Programme

Interventions

  • OtherINSPiRe Programme

    Intensive CBT for suicide

06

What researchers measure

Primary outcomes

  1. The Client Satisfaction Questionnaire (CSQ-8)

    A measure of participant satisfaction with therapy

    Time frame: 20 minutes

  2. Therapist Session Summary

    Measuring levels of adherence and engagement

    Time frame: 5 minutes

  3. Discharge summary sheet

    Capturing individuals' adherence to the programme or discharge from it

    Time frame: 15 minutes

  4. Therapist Rating Form

    Giving an overall picture of each individual's engagement and progress during the study.

    Time frame: 20 minutes

  5. Post-intervention interview

    Qualitative interview to explore the participant's experience of therapy

    Time frame: 1 hour

07

Study locations

1 site
  • HMP Risley
    Warrington, Greater Manchester WA3 6BP, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Apr 2019, 10 months.

Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 10 months is below that.

Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2018
First posted
Apr 17, 2018
StartActual
Jun 1, 2018
Primary completionActual
Apr 26, 2019
CompletionActual
Apr 26, 2019
Last update
Aug 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03499548
Responsible party
Jessica Killilea (University of Manchester, University of Manchester) — Principal investigator
First posted
Apr 17, 2018
Start date
Jun 1, 2018
Primary completion
Apr 26, 2019
Completion
Apr 26, 2019
Last update
Aug 12, 2019

Study contacts

Daniel Pratt
principal investigator · University of Manchester
Yvonne Awenat
study chair · University of Manchester
Charlotte Lennox
study chair · University of Manchester

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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