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Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants

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ClinicalTrials.gov Identifier: NCT01651091
Recruitment Status : Unknown
Verified August 2012 by Edo Shonin, Nottingham Trent University.
Recruitment status was:  Not yet recruiting
First Posted : July 26, 2012
Last Update Posted : August 7, 2012
Sponsor:
Collaborators:
Awake to Wisdom Foundation
Serco Group Plc
Information provided by (Responsible Party):
Edo Shonin, Nottingham Trent University

Tracking Information
First Submitted Date  ICMJE July 24, 2012
First Posted Date  ICMJE July 26, 2012
Last Update Posted Date August 7, 2012
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Risk of Reoffending
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
  • Anger levels
  • Self-esteem
  • Substance-use locus of control
  • Self-harming
  • Affective mood states
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants
Official Title  ICMJE Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants: A Randomized Controlled Trial
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Psychosocial Functioning
Intervention  ICMJE
  • Other: Meditation Awareness Training
    Psychotherapy Intervention
  • Other: Treatment as usual
Study Arms  ICMJE
  • Experimental: Meditation Awareness Training
    Intervention: Other: Meditation Awareness Training
  • Active Comparator: Treatment as Usual
    Intervention: Other: Treatment as usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 24, 2012)
102
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01651091
Other Study ID Numbers  ICMJE MAT-30072012-T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edo Shonin, Nottingham Trent University
Study Sponsor  ICMJE Nottingham Trent University
Collaborators  ICMJE
  • Awake to Wisdom Foundation
  • Serco Group Plc
Investigators  ICMJE Not Provided
PRS Account Nottingham Trent University
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP