Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-02-19 @ 7:01 AM
Study NCT ID:
NCT02894203
Status:
UNKNOWN
Last Update Posted:
2016-09-09
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychobiological Effects of Meditation on Offenders With Psychopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-03', 'studyFirstSubmitDate': '2016-08-30', 'studyFirstSubmitQcDate': '2016-09-03', 'lastUpdatePostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline emotional regulation', 'timeFrame': 'Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up', 'description': 'Difficulties in Emotion Regulation Scale'}, {'measure': 'Change from baseline attention', 'timeFrame': 'Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up', 'description': 'Attention Network Task'}, {'measure': 'Change from baseline self-awareness', 'timeFrame': 'Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up', 'description': 'Mindful Attention Awareness Scale'}, {'measure': 'Change from baseline inflammatory gene expression', 'timeFrame': 'Before the intervention and on the final day of the intervention'}], 'secondaryOutcomes': [{'measure': 'Change from baseline social learning', 'timeFrame': 'Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up', 'description': 'Social Learning Task (Diaconescu et al., 2014)'}, {'measure': 'Change from baseline risk-taking', 'timeFrame': 'Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up', 'description': 'Risk-taking Task (Tymula et al., 2012)'}, {'measure': 'Change from baseline empathy', 'timeFrame': 'Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up', 'description': 'Self-assessment Manikin (Seara \\& Cardoso, 2012).'}, {'measure': 'Change from baseline stress', 'timeFrame': 'Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up', 'description': 'Perceived Stress Scale'}, {'measure': 'Change from baseline affective states', 'timeFrame': 'Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up', 'description': 'Profile of Mood States'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mindfulness', 'Yoga']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male offenders with dangerous and severe personality disorder aged 18-65 who will remain in the prison until at least February 2017.\n\nExclusion Criteria:\n\n* Major psychiatric or neurological disorders, previous meditation or yoga experience, unable to follow instructions in English,'}, 'identificationModule': {'nctId': 'NCT02894203', 'briefTitle': 'Psychobiological Effects of Meditation on Offenders With Psychopathy', 'organization': {'class': 'OTHER', 'fullName': 'Coventry University'}, 'officialTitle': 'Psychological and Biological Effects of Intensive Mindfulness Meditation on Offenders With Dangerous and Severe Personality Disorder: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '13274-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hatha Yoga', 'interventionNames': ['Behavioral: Yoga']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list'}], 'interventions': [{'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Mindfulness']}, {'name': 'Yoga', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Hatha Yoga']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coventry University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Donders Centre for Cognitive Neuroimaging', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MA, Doctoral candidate', 'investigatorFullName': 'Ivana Buric', 'investigatorAffiliation': 'Coventry University'}}}}