- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01651091
Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants
August 6, 2012 updated by: Edo Shonin, Nottingham Trent University
Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants: A Randomized Controlled Trial
The purpose of this study is to investigate the effects of an eight-week long group-based secular intervention known as Meditation Awareness Training (MAT) on psychosocial functioning in prison participants.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In Western practitioner settings, Buddhist principles are increasingly being used in the treatment of a wide range of mental health issues.
However, there is a dearth of high quality research examining the effects of Buddhist-derived interventions (BDIs) on mental health in forensic settings.
The purpose of this study is to assess the salutary effects and acceptability of a secularised group-based eight-week BDI known as Meditation Awareness Training (MAT) against relevant predictors of adaptive psychosocial functioning and mental health in violent offenders.
A randomized controlled trial (RCT) design will be employed structured with reference to CONSORT (Consolidated Standards of Reporting Trials) 2010 guidelines.
English speaking adult males (aged 18-65 years) serving indeterminate prison sentences for offences of instrumental violence at a category B prison will be invited to receive MAT on a voluntary basis.
Computer-generated numbers will be used to randomly allocate prison participants (n=102 - based on statistical power calculations) to either an intervention or 'treatment as usual' (TAU) control condition.
Measures will be taken pre- and post-intervention and at three-month follow-up to assess maintenance effects.
Study Type
Interventional
Enrollment (Anticipated)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nottingham, United Kingdom, NG1 4BU
- Nottingham Trent University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Adult male (aged 18 to 65)
- English speaking
- Intact cognition(mini-mental status exam ≥23)
- Incarceration for an act of instrumental violence
- Evidence of self-harming and/or suicidal ideations and/or substance-use during the 12 months prior to the study.
Exclusion Criteria:
- current participation in a program of structured psychotherapy or counselling
- any prior formal meditation training
- psychopharmacology commenced or dosage changed one-month prior to intervention (stable medication permitted)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meditation Awareness Training
|
Psychotherapy Intervention
|
|
Active Comparator: Treatment as Usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Risk of Reoffending
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Anger levels
|
|
Self-esteem
|
|
Substance-use locus of control
|
|
Self-harming
|
|
Affective mood states
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Anticipated)
November 1, 2013
Study Registration Dates
First Submitted
July 24, 2012
First Submitted That Met QC Criteria
July 24, 2012
First Posted (Estimate)
July 26, 2012
Study Record Updates
Last Update Posted (Estimate)
August 7, 2012
Last Update Submitted That Met QC Criteria
August 6, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- MAT-30072012-T
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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