- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02894203
Psychobiological Effects of Meditation on Offenders With Psychopathy
Psychological and Biological Effects of Intensive Mindfulness Meditation on Offenders With Dangerous and Severe Personality Disorder: A Randomised Controlled Trial
The investigators aim to explore the psychobiological effects of a 5-day meditation intervention on offenders within dangerous and severe personality disorders (DSPD) unit at HMP Whitemoor. DSPD unit accommodates offenders with psychopathy or with two or more personality disorders. DPSD unit provides them with a 5-year rehabilitation programme that consists of group and individual therapy and aims to improve their self-regulation.
This project includes a total of 60 participants and has two major methodological innovations. First, it will include yoga as an active control group that will be matched to the meditation intervention (which means it will have the same length and the same social components) and a passive control group that will be following their usual regimen. Thus, the effects of meditation will be contrasted with another type of intervention and with not receiving any intervention.
The second methodological innovation is the combination of psychological and biological measures. Psychological measures include questionnaires (emotion regulation, mindfulness, stress) and cognitive measures (attention,empathy,behavioural control). Biological measures include EEG to measure brain activity related to empathy; gene expression and protein interlukin-6 to measure changes in immune system; and stress related hormone cortisol. The investigators also aim to determine to whom does meditation benefit the most by exploring how initial expectations of meditation, personality, mood and previous life adversity predict outcomes of meditation or yoga. The data will be collected at three time points: at baseline, immediately after and 10 weeks after the 5-day intervention.
The investigators expect that meditation and yoga will similarly improve mental and physical health. If this hypothesis are confirmed, these results will extend previous findings on the benefits of meditation and yoga to vulnerable populations, and would provide a cost-effective addition to prisoner rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male offenders with dangerous and severe personality disorder aged 18-65 who will remain in the prison until at least February 2017.
Exclusion Criteria:
- Major psychiatric or neurological disorders, previous meditation or yoga experience, unable to follow instructions in English,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness
|
|
No Intervention: Wait-list
|
|
Active Comparator: Hatha Yoga
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline emotional regulation
Time Frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Difficulties in Emotion Regulation Scale
|
Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Change from baseline attention
Time Frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Attention Network Task
|
Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Change from baseline self-awareness
Time Frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Mindful Attention Awareness Scale
|
Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Change from baseline inflammatory gene expression
Time Frame: Before the intervention and on the final day of the intervention
|
Before the intervention and on the final day of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline social learning
Time Frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Social Learning Task (Diaconescu et al., 2014)
|
Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Change from baseline risk-taking
Time Frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Risk-taking Task (Tymula et al., 2012)
|
Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Change from baseline empathy
Time Frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Self-assessment Manikin (Seara & Cardoso, 2012).
|
Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Change from baseline stress
Time Frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Perceived Stress Scale
|
Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Change from baseline affective states
Time Frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Profile of Mood States
|
Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13274-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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