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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01651091
Other study ID # MAT-30072012-T
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 24, 2012
Last updated August 6, 2012
Start date March 2013

Study information

Verified date August 2012
Source Nottingham Trent University
Contact Edo Shonin
Email edo.shonin@ntu.ac.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 102
Est. completion date
Est. primary completion date November 2013
Accepts healthy volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Meditation Awareness Training
Psychotherapy Intervention
Treatment as usual


Locations

Country Name City State
United Kingdom Nottingham Trent University Nottingham

Sponsors (3)

Lead Sponsor Collaborator
Nottingham Trent University Awake to Wisdom Foundation, Serco Group Plc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Risk of Reoffending
Secondary Anger levels
Secondary Self-esteem
Secondary Substance-use locus of control
Secondary Self-harming
Secondary Affective mood states
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