NCT05948917

Brief 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. 1.Do the mind-body skills groups increase resilience?
  2. 2.Do the mind-body skills groups decrease depression, anxiety and/or stress?
  3. 3.Do the mind-body skills groups increase participants' belief that they have improved coping skills?
  4. 4.Do the mind-body skills groups increase a sense of meaning in life?
  5. 5.Do the mind-body skills groups increase a sense of life purpose?
  6. 6.Do the mind-body skills groups increase self-esteem in women?
  7. 7.Do the mind-body skills groups decrease aggressive responses in men?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

June 30, 2023

Last Update Submit

December 3, 2025

Conditions

Keywords

mind-body medicineresilienceincarceratedmeditationprisoners

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    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

    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

    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

    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

    Baseline, 11 weeks, and at 3 month follow-up

  • +1 more secondary outcomes

Other Outcomes (1)

  • How the Mind-Body Medicine Skills Groups have Affected the Participants by using Focus Group Interviews

    11 weeks

Study Arms (1)

Behavioral: Mind-body Skills Groups

EXPERIMENTAL

10 mind-body skills groups held once a week.

Behavioral: Mind-Body Skills Groups

Interventions

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.

Behavioral: Mind-body Skills Groups

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Plainfield Correctional Facility

Indianapolis, Indiana, 46168, United States

Location

Indiana Women's Prison

Indianapolis, Indiana, 46214, United States

Location

Study Officials

  • Julie K Staples, PhD

    The Center for Mind-Body Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 17, 2023

Study Start

September 5, 2023

Primary Completion

June 19, 2025

Study Completion

June 19, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations