Well-beingNCT04747730
Fostering Inmates' Well-being and Mental Health
A study testing Transcendental Meditation training in people with Well-being, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Well-being
- What is being tested?
- Transcendental Meditation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 15 Dec 2019
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The meditation intervention consists of teaching four one-hour lessons of the Transcendental meditation technique developed and offered by the David Lynch Foundation. The technique involves the use of a sound (mantra) to effortlessly allow the mind to settle down to a state of inner calm. Meditation enables those who have learned it and regularly practice it to be more self-aware and respond in a calmer and more considered manner to whatever happens in their present experience.
- Conditions
- Well-being
- Being tested
- Transcendental Meditation training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental Meditation trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcendental Meditation training | Experimental | 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. Receives: Other: Transcendental Meditation training |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health: - GHQ 12 - SF-12 Health survey
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.
Measured: 4 months after training
Mental health: - GHQ 12 - SF-12 Health survey
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).
Measured: 4 months after training
Patience and trust
Two survey questions assessing propensity for delayed gratification:
- assessing propensity for delayed gratification using monetary values (scale 1 to 32, 32 is highest, 1 is lowest).
- assessing propensity for delayed gratification using subjective values (scale 0 to 10, higher numbers reflecting a greater propensity than lower ones).
One survey question on trust: scale from 0 to 10 (0 is lowest, 10 is highest).
Measured: 4 months after training
Positive reciprocity
Two survey questions:
- "When someone does me a favour are you willing to return it?" (scale from 0 to 10, where 0 is the lowest value and 10 the highest).
- Hypothetical scenario where someone helps the participant find their way. How much are they willing to provide as monetary reward for the help received? No scale. Outcome in pounds.
Measured: 4 months after training
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 Aug 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Why it stopped: unfortunately, the trial couldn't take place as planned as the investigators didn't manage to recruit a sufficient number of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-beingStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747730
- Sponsor's protocol ID
- 251271
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Inmates' Well-being and Mental Health Through Transcendental Meditation: a Prison Pilot
- ClinicalTrials.gov ID
- NCT04747730
- Acronym / sponsor ID
- 251271
- Conditions
- Well-being
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unfortunately, the trial couldn't take place as planned as the investigators didn't manage to recruit a sufficient number of participants.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (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.
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.
Detailed description
The meditation intervention consists of teaching four one-hour lessons of the Transcendental meditation technique developed and offered by the David Lynch Foundation. The technique involves the use of a sound (mantra) to effortlessly allow the mind to settle down to a state of inner calm. Meditation enables those who have learned it and regularly practice it to be more self-aware and respond in a calmer and more considered manner to whatever happens in their present experience.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcendental Meditation training | Experimental | Other: Transcendental Meditation trainingThe 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. |
| control | No intervention | –no intervention |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Transcendental Meditation trainingThe 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. | Other | Transcendental Meditation training |
Primary outcome
Mental health: - GHQ 12 - SF-12 Health survey
Time frame: 4 months after training
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.
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).
Patience and trust
Time frame: 4 months after training
Two survey questions assessing propensity for delayed gratification: 1. assessing propensity for delayed gratification using monetary values (scale 1 to 32, 32 is highest, 1 is lowest). 2. assessing propensity for delayed gratification using subjective values (scale 0 to 10, higher numbers reflecting a greater propensity than lower ones). One survey question on trust: scale from 0 to 10 (0 is lowest, 10 is highest).
Positive reciprocity
Time frame: 4 months after training
Two survey questions: 1. "When someone does me a favour are you willing to return it?" (scale from 0 to 10, where 0 is the lowest value and 10 the highest). 2. Hypothetical scenario where someone helps the participant find their way. How much are they willing to provide as monetary reward for the help received? No scale. Outcome in pounds.
Results and safety
The study was stopped early (reason given: unfortunately, the trial couldn't take place as planned as the investigators didn't manage to recruit a sufficient number of participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: No
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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 Transcendental Meditation training in people with Well-being, run by Queen Mary University of London 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?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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: stopped early, as of the sponsor's last update on 25 Jan 2022. 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 was stopped early (reason given: unfortunately, the trial couldn't take place as planned as the investigators didn't manage to recruit a sufficient number of participants.). Results are not available in the source record.
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?
Mental health: - GHQ 12 - SF-12 Health survey (time frame: 4 months after training). The study lists 4 primary outcomes in all. 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 25 Jan 2022.