NCT03499548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

March 19, 2018

Last Update Submit

August 9, 2019

Conditions

Suicide

Keywords

IntensiveCognitive Behavioral TherapyMale prisoners

Outcome Measures

Primary Outcomes (5)

  • The Client Satisfaction Questionnaire (CSQ-8)

    A measure of participant satisfaction with therapy

    20 minutes

  • Therapist Session Summary

    Measuring levels of adherence and engagement

    5 minutes

  • Discharge summary sheet

    Capturing individuals' adherence to the programme or discharge from it

    15 minutes

  • Therapist Rating Form

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

    20 minutes

  • Post-intervention interview

    Qualitative interview to explore the participant's experience of therapy

    1 hour

Study Arms (1)

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.

Other: INSPiRe Programme

Interventions

INSPiRe ProgrammeOTHER

Intensive CBT for suicide

Intervention

Eligibility Criteria

Age21 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAll participants will be recruited from a prison site that houses males.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HMP Risley

Warrington, Greater Manchester, WA3 6BP, United Kingdom

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Daniel Pratt

    University of Manchester

    PRINCIPAL INVESTIGATOR

  • Yvonne Awenat

    University of Manchester

    STUDY CHAIR

  • Charlotte Lennox

    University of Manchester

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University of Manchester

Study Record Dates

First Submitted

March 19, 2018

First Posted

April 17, 2018

Study Start

June 1, 2018

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)