- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04747730
Fostering Inmates' Well-being and Mental Health
Fostering Inmates' Well-being and Mental Health Through Transcendental Meditation: a Prison Pilot
The objective of the project was to provide an assessment of the impact of Transcendental Meditation on prison inmates' well-being. To achieve this goal the investigators conducted a before-and-after study in Her Majesty's Prison Warren Hill (HMP) (England). Meditation is correlated with better self-regulation and is innovative because it fosters generalisable psychological processes that support cognitive, emotional and behavioural regulation, with self-regulation being an important factor behind a variety of outcomes.
Unfortunately, the trial couldn't be completed as the investigators didn't manage to recruit a sufficient number of participants.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Woodbridge, United Kingdom, IP12 3BF
- HMP Warren Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- any inmate with no history of drug or alcohol abuse
- recreational drug users who have refrained from using drugs for two weeks before learning the meditation technique
- alcohol or drug addicts who are recovering from alcohol or drug use and have refrained from drug use for at least three months before taking part to the programme
Exclusion Criteria:
- informed consent not signed.
- expected stay in HMP Warren Hill shorter than six months since the beginning of the project.
- drug users and alcoholics not in rehabilitation
- people with serious mental health problems
- people who do not speak English as a first language.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Transcendental Meditation training
The intervention of the project is the teaching and learning of Transcendental Meditation technique.
The technique involves the use of a sound (mantra) to effortlessly allow the mind to settle down to a state of inner calm.
It is a simple, natural and effortless practise, and unlike other meditation strategies, it does not involve concentration or control of the mind.
The practice does not require any religion, philosophy, or change in lifestyle.
Once learned the technique, participants will practice it twice a day, 20 minutes every morning and 20 minutes in the afternoon.
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The programme targets inmates in HMP Warren Hill who are eligible to learn the meditation technique, who are staying in prison for at least six months since the beginning of the programme and who provide the signed informed consent.
The sample of eligible inmates is approximately 190 inmates out of 250 currently in the prison.
Inmates will be contacted by the research team in prison during introductory sessions of the research intervention.
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NO_INTERVENTION: control
no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mental health: - GHQ 12 - SF-12 Health survey
Time Frame: 4 months after training
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GHQ 12 was collected via survey questions. The General Health Questionnaire (GHQ) is a screening device for identifying minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients. Suitable for all ages from adolescent upwards - not children, it assesses the respondent's current state and asks if that differs from his or her usual state. It is therefore sensitive to short-term psychiatric disorders but not to long-standing attributes of the respondent. |
4 months after training
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Mental health: - GHQ 12 - SF-12 Health survey
Time Frame: 4 months after training
|
SF-12 was collected via survey questions. The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). |
4 months after training
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Patience and trust
Time Frame: 4 months after training
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Two survey questions assessing propensity for delayed gratification:
One survey question on trust: scale from 0 to 10 (0 is lowest, 10 is highest). |
4 months after training
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Positive reciprocity
Time Frame: 4 months after training
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Two survey questions:
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4 months after training
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 251271
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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