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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04746651
Other study ID # L19007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date January 17, 2020

Study information

Verified date February 2021
Source University of Glasgow
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 1. Will prisoners take part in and engage with LLTTF? 2. Do LLTTF booklets need to be adapted for prisoners? 3. Does LLTTF show an effect of reducing anxiety and/or depression? 4. Does history of HI reduce responsivity to LLTTF? 5. 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 17, 2020
Est. primary completion date January 17, 2020
Accepts healthy volunteers No
Gender Male
Age group 21 Years to 100 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Guided Self Help
Guided self help appointments with prison staff - 4x 30 minute appointments.

Locations

Country Name City State
United Kingdom University of Glasgow Glasgow

Sponsors (2)

Lead Sponsor Collaborator
University of Glasgow NHS Lanarkshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of prison officers who complete the LLTTF training and the number of prisoners who complete the 4 appointments of LLTTF. Quantitative Through study completion, 17/01/2020
Secondary Reports of the means of the PHQ-9 Quantitative Through study completion, an average of 4 weeks for each participant.
Secondary Reports of the means of the GAD-7 Quantitative Through study completion, average of 4 weeks for each participant.
Secondary The percentage of participants who believe the booklets need to be adapted for use in prison. Quantitative Through study completion, 17/01/2020
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