NCT04747730

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

January 29, 2021

Last Update Submit

January 24, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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).

    4 months after training

  • Patience and trust

    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 months after training

  • Positive reciprocity

    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.

    4 months after training

Study Arms (2)

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.

Other: Transcendental Meditation training

control

NO INTERVENTION

no intervention

Interventions

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.

Transcendental Meditation training

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HMP Warren Hill

Woodbridge, IP12 3BF, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 10, 2021

Study Start

August 1, 2019

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

January 25, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations