Clinical trial NCT02894203: Psychobiological Effects of Meditation on Offenders With Psychopathy
Official title: Psychological and Biological Effects of Intensive Mindfulness Meditation on Offenders With Dangerous and Severe Personality Disorder: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mindfulness
Yoga
Lead sponsor: Coventry University
Sponsor class: OTHER
Collaborators: name: Donders Institute for Brain, Cognition and Behavior
First posted: 2016-09-09
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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,

Primary outcomes:
measure: Change from baseline emotional regulation
timeFrame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
measure: Change from baseline attention
timeFrame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
measure: Change from baseline self-awareness
timeFrame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
measure: Change from baseline inflammatory gene expression
timeFrame: Before the intervention and on the final day of the intervention
Secondary outcomes:
measure: Change from baseline social learning
timeFrame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
measure: Change from baseline risk-taking
timeFrame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
measure: Change from baseline empathy
timeFrame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
measure: Change from baseline stress
timeFrame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
measure: Change from baseline affective states
timeFrame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Other outcomes:
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