MindfulnessNCT02894203
Psychobiological Effects of Meditation on Offenders With Psychopathy
A study testing Mindfulness and Yoga in people with Mindfulness and Yoga, run by Coventry University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Mindfulness, Yoga
- What is being tested?
- Mindfulness and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male offenders with dangerous and severe personality disorder aged 18-65 who will remain in the prison until at least February 2017.
Who cannot join
- Major psychiatric or neurological disorders, previous meditation or yoga experience, unable to follow instructions in English,
About this study
Official title: Psychological and Biological Effects of Intensive Mindfulness Meditation on Offenders With Dangerous and Severe Personality Disorder: A Randomised Controlled Trial
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.
Read more
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
- Being tested
- Mindfulness, Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
YogaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Not described Receives: Behavioral: Mindfulness |
| Hatha Yoga | Active comparator | Not described Receives: Behavioral: Yoga |
| Wait-list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline emotional regulation
Difficulties in Emotion Regulation Scale
Measured: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline attention
Attention Network Task
Measured: 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
Measured: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline inflammatory gene expression
Measured: Before the intervention and on the final day of the intervention
Secondary outcomes (5)
Change from baseline social learning
Social Learning Task (Diaconescu et al., 2014)
Measured: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline risk-taking
Risk-taking Task (Tymula et al., 2012)
Measured: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline empathy
Self-assessment Manikin (Seara \& Cardoso, 2012).
Measured: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline stress
Perceived Stress Scale
Measured: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline affective states
Profile of Mood States
Measured: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coventry University
- Sponsor type
- University, hospital or other
- Collaborators
- Donders Centre for Cognitive Neuroimaging
- Responsible party
- Principal investigator, Ivana Buric, Coventry University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894203
- Sponsor's protocol ID
- 13274-24
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Biological Effects of Intensive Mindfulness Meditation on Offenders With Dangerous and Severe Personality Disorder: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02894203
- Acronym / sponsor ID
- 13274-24
- Conditions
- Mindfulness, Yoga
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Coventry UniversityUniversity, hospital or other
- Collaborators
- Donders Centre for Cognitive Neuroimaging
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness |
| Hatha Yoga | Active comparator | Behavioral: Yoga |
| Wait-list | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male offenders with dangerous and severe personality disorder aged 18-65 who will remain in the prison until at least February 2017.
Key exclusion criteria (1 listed)
- Major psychiatric or neurological disorders, previous meditation or yoga experience, unable to follow instructions in English,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness | Behavioural | Mindfulness |
| Yoga | Behavioural | Hatha Yoga |
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
5 secondary outcomes
Change from baseline social learning
Time frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline risk-taking
Time frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline empathy
Time frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline stress
Time frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Change from baseline affective states
Time frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Yoga in people with Mindfulness and Yoga, run by Coventry University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline emotional regulation (time frame: Before the intervention, up to 2 weeks after the intervention and at 10-18 week follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.