Clinical Trial: Psychobiological Effects of Meditation on Offenders With Psychopathy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Coventry University

Current Primary Outcome:

• 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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)
• 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)
• 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).
• 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
• 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

Original Secondary Outcome: Same as current

Information By: Coventry University

Dates:
Date Received: August 30, 2016
Date Started: September 2016
Date Completion: February 2017
Last Updated: September 3, 2016
Last Verified: September 2016