Psychobiological Effects of Meditation on Offenders With Psychopathy

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02894203
• Other study ID #: 13274-24
• Status: Not yet recruiting
• Phase: N/A
• First received: August 30, 2016
• Last updated: September 3, 2016
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: September 2016
• Source: Coventry University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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,

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mindfulness
• Yoga

Intervention

Behavioral:
• Mindfulness

• Yoga

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Coventry University	Donders Institute for Brain, Cognition and Behavior

Outcome

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