ResilienceNCT05948917
Mind-Body Skills Groups for Incarcerated Men and Women
A study testing Mind-Body Skills Groups in people with Resilience, run by The Center for Mind-Body Medicine at 2 sites in United States.
Trial summary
The goal of this study is to learn about the effectiveness of a Mind-Body Skills Group program for incarcerated participants.The main questions is aims to answer are: 1. Do the mind-body skills groups increase resilience? 2. Do the mind-body skills groups decrease 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 Skills Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2023to 19 Jun 2025
- 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
2 sites in 1 country.
United States2 sites
Plainfield Correctional Facility
Indianapolis, Indiana, 46168
Indiana Women's Prison
Indianapolis, Indiana, 46214
About this study
The goal of this study is to learn about the effectiveness of a Mind-Body Skills Group program for incarcerated participants.The main questions is aims to answer are:
- Do the mind-body skills groups increase resilience?
- Do the mind-body skills groups decrease depression, anxiety and/or stress?
- Do the mind-body skills groups increase participants' belief that they have improved coping skills?
- Do the mind-body skills groups increase a sense of meaning in life?
- Do the mind-body skills groups increase a sense of life purpose?
- Do the mind-body skills groups increase self-esteem in women?
- Do the mind-body skills groups decrease aggressive responses in men?
- Conditions
- Resilience
- Being tested
- Mind-Body Skills Groups
- Keywords
- mind-body medicine, resilience, incarcerated, meditation, prisoners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Skills GroupsBehavioural
The mind-body skills groups consist of supportive small group sessions with about 8-10 participants per group. Participants of these groups learn and practice mind-body techniques including: meditation, self-expression through drawings, autogenics and biofeedback, guided imagery, body awareness, and genograms.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Mind-body Skills Groups | Experimental | 10 mind-body skills groups held once a week. Receives: Behavioral: Mind-Body Skills Groups |
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 10-session mind-body skills groups and at 3 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 10 sessions score- Baseline score; Follow-up score - After the 10 sessions score; and Follow-up Score - Baseline score
Measured: Baseline, 11 weeks, and at 3 month follow-up
Secondary outcomes (6)
Change from Baseline on depression, anxiety, and stress using the Depression Anxiety and Stress Scale -21 (DASS-21) after the 10-session mind-body skills groups and at 3 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 10 sessions scores- Baseline scores; Follow-up scores - After the 10 sessions scores; and Follow-up scores - Baseline scores
Measured: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on coping-self efficacy using the Coping Self-Efficacy (CSE) scale after the 10 session mind-body skills groups and at 3 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 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score.
Measured: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on meaning in life using the Meaning in Life Questionnaire (MLQ) after the 10 session mind-body skills groups and at 3 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 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score.
Measured: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on purpose in life using the the Life Engagement Test (LET) after the 10 session mind-body skills groups and at 3 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 greater levels of purpose in life.
Change = After the 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score.
Measured: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on self-esteem (females only) using the Rosenberg Self-Esteem Scale (RSE) after the 10 session mind-body skills groups and at 3 month follow-up
The RSE scale consists of 10 items scored on a 4-point scale with responses that range from "not at all like me" to "completely like me". Higher scores represent greater self-esteem.
Change = After the 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score.
Measured: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on aggression (males only) using the Aggression Questionnaire (AQ) after the 10 session mind-body skills groups and at 3 month follow-up.
Improvements in aggression will be measured using the Aggression Questionnaire (AQ) which is a revision of the Buss-Durkee Hostility Inventory that has been widely used to measure aggression.The AQ consists of 34 items scored on a 5-point Likert-type scale with responses ranging from "not at all like me" to "completely like me". The AQ has the following subscales: physical aggression, verbal aggression, anger, hostility, and indirect aggression. Higher scores represent greater aggression according to these components.
Change = After the 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score.
Measured: Baseline, 11 weeks, and at 3 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 posted17 Jul 2023
- Study start5 Sep 2023
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Mind-Body Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Herbert 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
- NCT05948917
- Sponsor's protocol ID
- CMBMIndianaPrisons002
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-Body Skills Groups for Incarcerated Men and Women
- ClinicalTrials.gov ID
- NCT05948917
- Acronym / sponsor ID
- CMBMIndianaPrisons002
- Conditions
- Resilience
- Keywords
- mind-body medicine, resilience, incarcerated, meditation, prisoners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- The Center for Mind-Body MedicineUniversity, hospital or other
- Collaborators
- Herbert Simon Family Foundation
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 17 Jul 2023 (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 the effectiveness of a Mind-Body Skills Group program for incarcerated participants.The main questions is aims to answer are:
- Do the mind-body skills groups increase resilience?
- Do the mind-body skills groups decrease depression, anxiety and/or stress?
- Do the mind-body skills groups increase participants' belief that they have improved coping skills?
- Do the mind-body skills groups increase a sense of meaning in life?
- Do the mind-body skills groups increase a sense of life purpose?
- Do the mind-body skills groups increase self-esteem in women?
- Do the mind-body skills groups decrease aggressive responses in men?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Mind-body Skills Groups | Experimental | Behavioral: Mind-Body Skills Groups10 mind-body skills groups held once a week. |
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 Skills GroupsThe mind-body skills groups consist of supportive small group sessions with about 8-10 participants per group. Participants of these groups learn and practice mind-body techniques including: meditation, self-expression through drawings, autogenics and biofeedback, guided imagery, body awareness, and genograms. | Behavioural | Behavioral: Mind-body Skills Groups |
Primary outcome
Change from Baseline on resilience using the Connor-Davidson Resilience Scale (CD-RISC) after the 10-session mind-body skills groups and at 3 month follow-up.
Time frame: Baseline, 11 weeks, and at 3 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 10 sessions score- Baseline score; Follow-up score - After the 10 sessions score; and Follow-up Score - Baseline score
6 secondary outcomes
Change from Baseline on depression, anxiety, and stress using the Depression Anxiety and Stress Scale -21 (DASS-21) after the 10-session mind-body skills groups and at 3 month follow-up.
Time frame: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on coping-self efficacy using the Coping Self-Efficacy (CSE) scale after the 10 session mind-body skills groups and at 3 month follow-up
Time frame: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on meaning in life using the Meaning in Life Questionnaire (MLQ) after the 10 session mind-body skills groups and at 3 month follow-up
Time frame: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on purpose in life using the the Life Engagement Test (LET) after the 10 session mind-body skills groups and at 3 month follow-up
Time frame: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on self-esteem (females only) using the Rosenberg Self-Esteem Scale (RSE) after the 10 session mind-body skills groups and at 3 month follow-up
Time frame: Baseline, 11 weeks, and at 3 month follow-up
Change from Baseline on aggression (males only) using the Aggression Questionnaire (AQ) after the 10 session mind-body skills groups and at 3 month follow-up.
Time frame: Baseline, 11 weeks, and at 3 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 10 Dec 2025.
- Individual participant dataSharing planned: No
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Skills Groups in people with Resilience, run by The Center for Mind-Body Medicine at 2 sites 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 10-session mind-body skills groups and at 3 month follow-up. (time frame: Baseline, 11 weeks, and at 3 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 10 Dec 2025.