Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fostering Inmates' Well-being and Mental Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04747730
Recruitment Status : Terminated (unfortunately, the trial couldn't take place as planned as the investigators didn't manage to recruit a sufficient number of participants.)
First Posted : February 10, 2021
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Well-being Other: Transcendental Meditation training Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fostering Inmates' Well-being and Mental Health Through Transcendental Meditation: a Prison Pilot
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : December 15, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Transcendental Meditation training
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.

No Intervention: control
no intervention



Primary Outcome Measures :
  1. 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.


  2. 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).


  3. 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).


  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747730


Locations
Layout table for location information
United Kingdom
HMP Warren Hill
Woodbridge, United Kingdom, IP12 3BF
Sponsors and Collaborators
Queen Mary University of London
Layout table for additonal information
Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT04747730    
Other Study ID Numbers: 251271
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No