CClinicalTrials.gg
CompletedNCT05622799Updated Jan 23, 2025

Mind-Body Medicine Training for Incarcerated Men and Women

An interventional study of Mind-Body Medicine Training Program in Resilience, sponsored by The Center for Mind-Body Medicine. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.

Sponsored by The Center for Mind-Body Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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. Does the training program increase optimism?
  4. Does the training program increase prisoners' belief that they can have better coping skills?
  5. Does the training program increase a sense of meaning in life?
  6. 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.

02

Conditions studied

  • Resilience

Keywords

  • Mind-body therapies
  • Resilience
  • Prisoners
  • Meditation
03

In context

Lead sponsor

The Center for Mind-Body Medicine is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  1. Having any of the following before the study is completed:
  1. a sentence that will end,
  2. a scheduled change in security level to a minimum-security prison or,
  3. 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

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Mind-Body MedicineTraining

    A two part (4 days for each part) mind-body medicine training program

    Behavioral: Mind-Body Medicine Training Program

Interventions

  • BehavioralMind-Body Medicine Training Program

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, after the 8 day training, and at 6 month follow-up

Secondary outcomes

  1. 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

    Time frame: Baseline, after the 8 day training, and at 6 month follow-up

  2. 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.

    Time frame: Baseline, after the 8 day training, and 6 month follow-up

  3. 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.

    Time frame: Baseline, after the 8 day training, at 6 month follow-up

  4. 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.

    Time frame: Baseline, after the 8 day training, and at 6 month follow-up

  5. 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.

    Time frame: Baseline, after the 8 day training, and at 6 month follow-up

Other outcomes

  1. How the Mind-Body Medicine Training has Affected the Participants by using Focus Group Interviews

    Two focus group interviews will be conducted with approximately 10 participants each. Focus group questions will cover topics such as practice of the mind-body techniques, how the training has affected the participant in terms of relationships, how they view their future, and how they are going to used what they have learned.

    Time frame: After the 8 day training and at 6-month follow-up

07

Study locations

1 site
  • Indiana Department of Correction
    Indianapolis, Indiana 46204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05622799
Lead sponsor
The Center for Mind-Body Medicine
Collaborators
Simon Family Foundation
Responsible party
Julie K. Staples (Research Director, The Center for Mind-Body Medicine) — Principal investigator
First posted
Nov 21, 2022
Start date
Nov 21, 2022
Primary completion
Feb 19, 2024
Completion
Feb 19, 2024
Last update
Jan 23, 2025

Study contacts

Julie K Staples, PhD
principal investigator · The Center for Mind-Body Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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