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A Feasibility Study of a Guided Self-help Programme for Male Offenders Serving a Long-term Prison Sentence

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Guided Self Help
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Feasibility study, Prisoners, Male offenders, Guided self help, Anxiety, Low mood

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Eligible prisoners were adult males (aged 21+) at HMP Shotts who experienced mild-severe levels of psychological distress (defined as PHQ score of 5+), were prepared to attend four sessions of the guided self-help, able to read and write, and able to engage in the guided self-help.

Prisoners were excluded if deemed, by Prison Officers or healthcare staff, to pose a direct risk of harm to the field researcher (or were at risk of imminent and significant self-harm).

Sites / Locations

  • University of Glasgow

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guided Self Help

Arm Description

Four guided self-help booklets were used; "Why do I feel so bad?" covered formulation/understanding feelings, "I can't be bothered doing anything" centred on activity scheduling, "Why does everything always go wrong?" focused on thought-challenging, and "How to fix almost everything" incorporated problem solving. Linked worksheets were adapted following feedback from Prison Officers.

Outcomes

Primary Outcome Measures

The number of prison officers who complete the LLTTF training and the number of prisoners who complete the 4 appointments of LLTTF.
Quantitative

Secondary Outcome Measures

Reports of the means of the PHQ-9
Quantitative
Reports of the means of the GAD-7
Quantitative
The percentage of participants who believe the booklets need to be adapted for use in prison.
Quantitative

Full Information

First Posted
February 11, 2019
Last Updated
February 8, 2021
Sponsor
University of Glasgow
Collaborators
NHS Lanarkshire
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1. Study Identification

Unique Protocol Identification Number
NCT04746651
Brief Title
A Feasibility Study of a Guided Self-help Programme for Male Offenders Serving a Long-term Prison Sentence
Official Title
Evaluating the Feasibility of a Guided Self-help Programme for an Adult Male Population of Offenders Serving a Long-term Prison Sentence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
NHS Lanarkshire

4. Oversight

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

5. Study Description

Brief Summary
Background: Prisoners have complex mental health needs, and there is a disproportionately higher incidence of mental health problems compared with the general population. Although research indicates that psychological interventions are effective in treating prisoners with anxiety and depression, medication is often the only treatment available in prisons. Living Life To The Full (LLTTF) is a life skills programme teaching skills to cope with life stresses, and has been shown to reduce anxiety and depression in individuals in the community. Research Questions Will prisoners take part in and engage with LLTTF? Do LLTTF booklets need to be adapted for prisoners? Does LLTTF show an effect of reducing anxiety and/or depression? Does history of HI reduce responsivity to LLTTF? Does LLTTF reduce number of breaches of prison rules? What did the study involve?: Prison Officers in HMP Shotts were invited to take part and attend LLTTF training. Male prisoners aged 21 and above in HMP Shotts were recruited using posters. Assessment of anxiety, depression, perceived functioning, and history of head injury was carried out. Prisoners' work attendance and breaches of prison rules for the month prior to and month during LLTTF was collected. Prison Officers and prisoners provided feedback of LLTTF at end of treatment. Results: Six (6%) Prison Officers attended LLTTF training and two (33%) withdrew prior to prisoner recruitment. 6% (n=15) of prisoners invited to take part volunteered and were eligible. Seven prisoners completed LLTTF. There was a sign of a treatment effect with reductions in depression following LLTTF. Anxiety reduced at the last session and increased at post-treatment, which reflects the deterioration in a minority of prisoners. Due to the small sample size, history of HI and responsivity was not explored. Prisoners were not on report the month prior to LLTTF, therefore impact on breached rules was not explored. Feedback from Prison Officers and prisoners indicated materials required adaptation for prison, such as including activities feasible in prison. Prison Officers highlighted practical barriers to delivery of LLTTF, including limited time. Conclusions: Guided self-help in prison is worth pursuing. Revision of materials with Prison Officers and prisoners is recommended, and evaluated in future research. Due to practical barriers reported by Prison Officers, designated guided self-help workers may be better placed to deliver this intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Feasibility study, Prisoners, Male offenders, Guided self help, Anxiety, Low mood

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Guided Self Help
Arm Type
Experimental
Arm Description
Four guided self-help booklets were used; "Why do I feel so bad?" covered formulation/understanding feelings, "I can't be bothered doing anything" centred on activity scheduling, "Why does everything always go wrong?" focused on thought-challenging, and "How to fix almost everything" incorporated problem solving. Linked worksheets were adapted following feedback from Prison Officers.
Intervention Type
Other
Intervention Name(s)
Guided Self Help
Intervention Description
Guided self help appointments with prison staff - 4x 30 minute appointments.
Primary Outcome Measure Information:
Title
The number of prison officers who complete the LLTTF training and the number of prisoners who complete the 4 appointments of LLTTF.
Description
Quantitative
Time Frame
Through study completion, 17/01/2020
Secondary Outcome Measure Information:
Title
Reports of the means of the PHQ-9
Description
Quantitative
Time Frame
Through study completion, an average of 4 weeks for each participant.
Title
Reports of the means of the GAD-7
Description
Quantitative
Time Frame
Through study completion, average of 4 weeks for each participant.
Title
The percentage of participants who believe the booklets need to be adapted for use in prison.
Description
Quantitative
Time Frame
Through study completion, 17/01/2020

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligible prisoners were adult males (aged 21+) at HMP Shotts who experienced mild-severe levels of psychological distress (defined as PHQ score of 5+), were prepared to attend four sessions of the guided self-help, able to read and write, and able to engage in the guided self-help. Prisoners were excluded if deemed, by Prison Officers or healthcare staff, to pose a direct risk of harm to the field researcher (or were at risk of imminent and significant self-harm).
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

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A Feasibility Study of a Guided Self-help Programme for Male Offenders Serving a Long-term Prison Sentence

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