Psychobiological Effects of Meditation on Offenders With Psychopathy

NCT02894203 | Unknown

• 1 other identifier: 13274-24
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mindfulness; Yoga

Outcome Measures

Primary Outcomes (4)

• 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

• Change from baseline attention

  Attention Network Task

  Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up

• 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

• Change from baseline inflammatory gene expression

  Before the intervention and on the final day of the intervention

Secondary Outcomes (5)

• 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 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 affective states

  Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up

Study Arms (3)

Mindfulness

EXPERIMENTAL

Behavioral: Mindfulness

Hatha Yoga

ACTIVE COMPARATOR

Behavioral: Yoga

Wait-list

NO INTERVENTION

Interventions

Mindfulness BEHAVIORAL

Mindfulness

Yoga BEHAVIORAL

Hatha Yoga

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male offenders with dangerous and severe personality disorder aged 18-65 who will remain in the prison until at least February 2017.

You may not qualify if:

• Major psychiatric or neurological disorders, previous meditation or yoga experience, unable to follow instructions in English,

Sponsors & Collaborators

• Coventry University: lead
• Donders Centre for Cognitive Neuroimaging: collaborator

MeSH Terms

Interventions

Mindfulness; Yoga

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MA, Doctoral candidate

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 9, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 9, 2016

Record last verified: 2016-09