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Clinical Trials/NCT02894203
NCT02894203UnknownNot Applicable

Psychological and Biological Effects of Intensive Mindfulness Meditation on Offenders With Dangerous and Severe Personality Disorder: A Randomised Controlled Trial

Coventry University0 sites60 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Primary Endpoint
Change from baseline emotional regulation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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,

Arms & Interventions

Mindfulness

Experimental

Intervention: Mindfulness (Behavioral)

Hatha Yoga

Active Comparator

Intervention: Yoga (Behavioral)

Wait-list

No Intervention

Outcomes

Primary Outcomes

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

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

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

Change from baseline inflammatory gene expression

Time Frame: Before the intervention and on the final day of the intervention

Secondary Outcomes

  • Change from baseline risk-taking(Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up)
  • Change from baseline empathy(Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up)
  • Change from baseline stress(Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up)
  • Change from baseline social learning(Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up)
  • Change from baseline affective states(Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ivana Buric

MA, Doctoral candidate

Coventry University

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