AnxietyNCT04746651
A Feasibility Study of a Guided Self-help Programme for Male Offenders Serving a Long-term Prison Sentence
A study testing Guided Self Help in people with Anxiety and Depression, run by University of Glasgow at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 21 to 100 years, men only
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Guided Self Help
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2019to 17 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Feasibility of a Guided Self-help Programme for an Adult Male Population of Offenders Serving a Long-term Prison Sentence
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
Read more
- 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.
- Conditions
- Anxiety, Depression
- Being tested
- Guided Self Help
- Keywords
- Feasibility study, Prisoners, Male offenders, Guided self help, Anxiety, Low mood
- Medical subject headings
- Anxiety Disorders, Depression, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self HelpOther
Guided self help appointments with prison staff - 4x 30 minute appointments.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Guided Self Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of prison officers who complete the LLTTF training and the number of prisoners who complete the 4 appointments of LLTTF.
Quantitative
Measured: Through study completion, 17/01/2020
Secondary outcomes (3)
Reports of the means of the PHQ-9
Quantitative
Measured: Through study completion, an average of 4 weeks for each participant.
Reports of the means of the GAD-7
Quantitative
Measured: 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.
Quantitative
Measured: Through study completion, 17/01/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Mar 2019
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lanarkshire
- Responsible party
- Principal investigator, Jennifer Lai, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746651
- Sponsor's protocol ID
- L19007
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Guided Self-help Programme for an Adult Male Population of Offenders Serving a Long-term Prison Sentence
- ClinicalTrials.gov ID
- NCT04746651
- Acronym / sponsor ID
- L19007
- Conditions
- Anxiety, Depression
- Keywords
- Feasibility study, Prisoners, Male offenders, Guided self help, Anxiety, Low mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Lanarkshire
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided Self Help | Experimental | Other: Guided Self HelpFour 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self HelpGuided self help appointments with prison staff - 4x 30 minute appointments. | Other | Guided Self Help |
Primary outcome
The number of prison officers who complete the LLTTF training and the number of prisoners who complete the 4 appointments of LLTTF.
Time frame: Through study completion, 17/01/2020
Quantitative
3 secondary outcomes
Reports of the means of the PHQ-9
Time frame: Through study completion, an average of 4 weeks for each participant.
Reports of the means of the GAD-7
Time frame: 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.
Time frame: Through study completion, 17/01/2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
Related trials for Anxiety
Recruiting
TOUCHminds: Help-seeking in Adolescents With Anxiety
Anxiety Symptoms, Anxiety Disorders
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
AI-Based CBT Chatbot for Adolescent Social Anxiety
AI-CBT Intervention Group, Waitlist Control Group
Not yet recruitingObservational study
Music Therapy and Sedation for Pain and Anxiety During Oocyte Retrieval
ANXIETY
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self Help in people with Anxiety and Depression, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of prison officers who complete the LLTTF training and the number of prisoners who complete the 4 appointments of LLTTF. (time frame: Through study completion, 17/01/2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.