Psychosocial FunctioningNCT01651091
Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants
A study testing Meditation Awareness Training and Treatment as usual in people with Psychosocial Functioning, run by Nottingham Trent University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Psychosocial Functioning
- What is being tested?
- Meditation Awareness Training and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Edo Shonin contact
United Kingdom1 site
Nottingham Trent University
Nottingham, NG1 4BU
Edo Shonin, edo.shonin@ntu.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychosocial Functioning
- Being tested
- Meditation Awareness Training, Treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation Awareness TrainingOther
Psychotherapy Intervention
Treatment as usualOther
| Study group | Role | What they receive |
|---|---|---|
| Meditation Awareness Training | Experimental | Not described Receives: Other: Meditation Awareness Training |
| Treatment as Usual | Active comparator | Not described Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Reoffending
Secondary outcomes (5)
Anger levels
Self-esteem
Substance-use locus of control
Self-harming
Affective mood states
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startMar 2013
- Primary completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial FunctioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- Awake to Wisdom Foundation, Serco Group Plc
- Responsible party
- Principal investigator, Edo Shonin, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651091
- Sponsor's protocol ID
- MAT-30072012-T
- Status last verified
- Aug 2012
- First submitted
- 24 Jul 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01651091
- Acronym / sponsor ID
- MAT-30072012-T
- Conditions
- Psychosocial Functioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- Awake to Wisdom Foundation, Serco Group Plc
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (estimated)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Awareness Training | Experimental | Other: Meditation Awareness Training |
| Treatment as Usual | Active comparator | Other: Treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation Awareness TrainingPsychotherapy Intervention | Other | Meditation Awareness Training |
| Treatment as usual | Other | Treatment as Usual |
Primary outcome
Risk of Reoffending
5 secondary outcomes
Anger levels
Self-esteem
Substance-use locus of control
Self-harming
Affective mood states
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edo Shonin contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation Awareness Training and Treatment as usual in people with Psychosocial Functioning, run by Nottingham Trent University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edo Shonin (edo.shonin@ntu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of Reoffending. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.