ResilienceNCT05622799
Mind-Body Medicine Training for Incarcerated Men and Women
A study testing Mind-Body Medicine Training Program in people with Resilience, run by The Center for Mind-Body Medicine at 1 site in United States.
Trial summary
The goal of this study is to learn about how effective a Mind-Body Medicine Training Program is for prisoners. The main questions it aims to answer are: 1. Does the training program increase resilience? 2. Does the training program reduce depression, anxiety, and/or stress? 3. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resilience
- What is being tested?
- Mind-Body Medicine Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2022to 19 Feb 2024
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria for this study will be English-speaking incarcerated individuals at the Indiana Women's Prison and and at the Plainfield Correctional Facility.
Who cannot join
- 1. Having any of the following before the study is completed:
- a sentence that will end,
- a scheduled change in security level to a minimum-security prison or,
- a scheduled work release;
- Or 2. Having conduct problems and/or emotional or mental instability that prevents safe and effective participation in the mind-body medicine training program
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Department of Correction
Indianapolis, Indiana, 46204
About this study
The goal of this study is to learn about how effective a Mind-Body Medicine Training Program is for prisoners. The main questions it aims to answer are:
- Does the training program increase resilience?
- Does the training program reduce depression, anxiety, and/or stress?
- Does the training program increase optimism?
- Does the training program increase prisoners' belief that they can have better coping skills?
- Does the training program increase a sense of meaning in life?
- Does the training program increase a sense of life purpose?
Participants will attend a 2-part mind-body medicine training program (4 days for each part) and will fill out questionnaires before the training, after the training and 6 months after the training. They will also participate in group interviews after the training and 6 months after the training.
- Conditions
- Resilience
- Being tested
- Mind-Body Medicine Training Program
- Keywords
- Mind-body therapies, Resilience, Prisoners, Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Medicine Training ProgramBehavioural
A mind-body medicine training program that teaches mind-body skills including meditation, autogenics and biofeedback, guided imagery, body awareness, genograms, and self-expression through writing and drawings. The first 4 day training consists of lectures and small groups where the mind-body techniques are practiced. The second 4 day training allows participants to lead a mind-body skills group and teach the techniques under supervision.
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body MedicineTraining | Experimental | A two part (4 days for each part) mind-body medicine training program Receives: Behavioral: Mind-Body Medicine Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on Resilience using the Connor-Davidson Resilience Scale (CD-RISC) after the 8 day training and at 6 month follow-up
The CD-RISC is a validated, self-report instrument assessing resilience over the last month. The CD-RISC consists of 25 questions that are rated on a 5-point scale with higher scores representing greater resilience. Change = After the 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up Score - Baseline score
Measured: Baseline, after the 8 day training, and at 6 month follow-up
Secondary outcomes (5)
Change from Baseline on Depression, Anxiety, and Stress using the Depression Anxiety and Stress Scale -21 (DASS-21) after the 8 day training and at 6 month follow-up
The DASS-21 is a validated, self-report instrument assessing the emotional states of depression, anxiety ans stress over the past week. The DASS-21 consists of 7 questions each for depression anxiety and stress are rated on a 4-point scale with higher scores representing higher levels of depression, anxiety, and stress. Change = After the 8 day training scores- Baseline scores; Follow-up scores - After the 8 day training scores; and Follow-up scores - Baseline scores
Measured: Baseline, after the 8 day training, and at 6 month follow-up
Change from Baseline on optimism using the Life Orientation Test - Revised (LOT-R) after the 8 day training and at 6 month follow-up
The LOT-R is a validated, self-report instrument assessing optimism. The LOT-R consists of 10 questions that are rated on a 5-point scale. Four of the questions are "filler questions" and are not calculated in the total score. Higher scores represent greater levels of optimism. Change = After the 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up score - Baseline score.
Measured: Baseline, after the 8 day training, and 6 month follow-up
Change from Baseline on coping - self efficacy using the Coping Self-Efficacy (CSE) Scale after the 8 day training and 6 month follow-up
The CSE Scale is a validated, self-report instrument assessing coping self-efficacy. The CSE scale consists of 26 questions that are rated on scale from 0 "cannot do at all" to 10 "certain can do". Higher scores represent greater levels of coping self-efficacy. Change = After the 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up score - Baseline score.
Measured: Baseline, after the 8 day training, at 6 month follow-up
Change from Baseline on meaning in life using the Meaning in Life Questionnaire (MLQ) after the 8 day training and 6 month follow-up
The MLQ is a validated, self-report instrument assessing meaning in life. The MLQ consists of 10 questions that are rated on 7- point scale. There are 2 subscales: presence of meaning and search for meaning. Higher scores represent greater levels of these two components of meaning in life. Change = After the 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up score - Baseline score.
Measured: Baseline, after the 8 day training, and at 6 month follow-up
Change from Baseline on purpose in life using the Life Engagement Test (LET) after the 8 day training and 6 month follow-up.
The LET is a 6-item scale made up of items that are framed in half positive and half negative directions. These items are then rated using a 5-point scale that ranges from "1 = strongly disagree" to "5 = strongly agree". Higher scores represent a greater sense of life purpose. Change = After the 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up score - Baseline score.
Measured: Baseline, after the 8 day training, and at 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start21 Nov 2022
- Primary completion19 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-controlled repeated measures
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Mind-Body Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Simon Family Foundation
- Responsible party
- Principal investigator, Julie K. Staples, The Center for Mind-Body Medicine
- Investigators
- Julie K Staples, PhD, Principal investigator, The Center for Mind-Body Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622799
- Sponsor's protocol ID
- CMBMIndianaPrison001
- Status last verified
- Jan 2025
- First submitted
- 7 Nov 2022
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-Body Medicine Training for Incarcerated Men and Women
- ClinicalTrials.gov ID
- NCT05622799
- Acronym / sponsor ID
- CMBMIndianaPrison001
- Conditions
- Resilience
- Keywords
- Mind-body therapies, Resilience, Prisoners, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The Center for Mind-Body MedicineUniversity, hospital or other
- Collaborators
- Simon Family Foundation
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 21 Nov 2022 (actual)
- 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 goal of this study is to learn about how effective a Mind-Body Medicine Training Program is for prisoners. The main questions it aims to answer are:
- Does the training program increase resilience?
- Does the training program reduce depression, anxiety, and/or stress?
- Does the training program increase optimism?
- Does the training program increase prisoners' belief that they can have better coping skills?
- Does the training program increase a sense of meaning in life?
- Does the training program increase a sense of life purpose?
Participants will attend a 2-part mind-body medicine training program (4 days for each part) and will fill out questionnaires before the training, after the training and 6 months after the training. They will also participate in group interviews after the training and 6 months after the training.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-controlled repeated measures
| Arm | Type | Receives |
|---|---|---|
| Mind-Body MedicineTraining | Experimental | Behavioral: Mind-Body Medicine Training ProgramA two part (4 days for each part) mind-body medicine training program |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria for this study will be English-speaking incarcerated individuals at the Indiana Women's Prison and and at the Plainfield Correctional Facility.
Key exclusion criteria (5 listed)
- a sentence that will end,
- a scheduled change in security level to a minimum-security prison or,
- a scheduled work release;
- Or 2. Having conduct problems and/or emotional or mental instability that prevents safe and effective participation in the mind-body medicine training program
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 |
|---|---|---|
| Mind-Body Medicine Training ProgramA mind-body medicine training program that teaches mind-body skills including meditation, autogenics and biofeedback, guided imagery, body awareness, genograms, and self-expression through writing and drawings. The first 4 day training consists of lectures and small groups where the mind-body techniques are practiced. The second 4 day training allows participants to lead a mind-body skills group and teach the techniques under supervision. | Behavioural | Mind-Body MedicineTraining |
Primary outcome
Change from Baseline on Resilience using the Connor-Davidson Resilience Scale (CD-RISC) after the 8 day training and at 6 month follow-up
Time frame: Baseline, after the 8 day training, and at 6 month follow-up
The CD-RISC is a validated, self-report instrument assessing resilience over the last month. The CD-RISC consists of 25 questions that are rated on a 5-point scale with higher scores representing greater resilience. Change = After the 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up Score - Baseline score
5 secondary outcomes
Change from Baseline on Depression, Anxiety, and Stress using the Depression Anxiety and Stress Scale -21 (DASS-21) after the 8 day training and at 6 month follow-up
Time frame: Baseline, after the 8 day training, and at 6 month follow-up
Change from Baseline on optimism using the Life Orientation Test - Revised (LOT-R) after the 8 day training and at 6 month follow-up
Time frame: Baseline, after the 8 day training, and 6 month follow-up
Change from Baseline on coping - self efficacy using the Coping Self-Efficacy (CSE) Scale after the 8 day training and 6 month follow-up
Time frame: Baseline, after the 8 day training, at 6 month follow-up
Change from Baseline on meaning in life using the Meaning in Life Questionnaire (MLQ) after the 8 day training and 6 month follow-up
Time frame: Baseline, after the 8 day training, and at 6 month follow-up
Change from Baseline on purpose in life using the Life Engagement Test (LET) after the 8 day training and 6 month follow-up.
Time frame: Baseline, after the 8 day training, and at 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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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.
Julie K Staples, PhD principal investigator
The Center for Mind-Body Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Medicine Training Program in people with Resilience, run by The Center for Mind-Body Medicine at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 on Resilience using the Connor-Davidson Resilience Scale (CD-RISC) after the 8 day training and at 6 month follow-up (time frame: Baseline, after the 8 day training, and at 6 month follow-up). 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 23 Jan 2025.