Mindfulness Clinical Trial
Official title:
Psychological and Biological Effects of Intensive Mindfulness Meditation on Offenders With Dangerous and Severe Personality Disorder: A Randomised Controlled Trial
Verified date | September 2016 |
Source | Coventry University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
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, |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Coventry University | Donders Institute for Brain, Cognition and Behavior |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline emotional regulation | Difficulties in Emotion Regulation Scale | Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up | No |
Primary | Change from baseline attention | Attention Network Task | Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up | No |
Primary | Change from baseline self-awareness | Mindful Attention Awareness Scale | Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up | No |
Primary | Change from baseline inflammatory gene expression | Before the intervention and on the final day of the intervention | Yes | |
Secondary | Change from baseline social learning | Social Learning Task (Diaconescu et al., 2014) | Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up | No |
Secondary | Change from baseline risk-taking | Risk-taking Task (Tymula et al., 2012) | Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up | No |
Secondary | Change from baseline empathy | Self-assessment Manikin (Seara & Cardoso, 2012). | Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up | No |
Secondary | Change from baseline stress | Perceived Stress Scale | Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up | |
Secondary | Change from baseline affective states | Profile of Mood States | Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up |
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