NCT04746651

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

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Mar 2019

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

February 11, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 11, 2019

Last Update Submit

February 8, 2021

Conditions

AnxietyDepression

Keywords

Feasibility studyPrisonersMale offendersGuided self helpAnxietyLow mood

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Reports of the means of the PHQ-9

    Through study completion, an average of 4 weeks for each participant.

  • Reports of the means of the GAD-7

    Through study completion, average of 4 weeks for each participant.

  • The percentage of participants who believe the booklets need to be adapted for use in prison.

    Through study completion, 17/01/2020

Study Arms (1)

Guided Self Help

EXPERIMENTAL

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.

Other: Guided Self Help

Interventions

Guided Self HelpOTHER

Guided self help appointments with prison staff - 4x 30 minute appointments.

Guided Self Help

Eligibility Criteria

Age21 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionConsciousness Disorders

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive Disorders

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
Trainee Clinical Psychologist

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 10, 2021

Study Start

March 1, 2019

Primary Completion

January 17, 2020

Study Completion

January 17, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

GB(1)