NCT05622799

Brief 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. 1.Does the training program increase resilience?
  2. 2.Does the training program reduce depression, anxiety, and/or stress?
  3. 3.Does the training program increase optimism?
  4. 4.Does the training program increase prisoners' belief that they can have better coping skills?
  5. 5.Does the training program increase a sense of meaning in life?
  6. 6.Does the training program increase a sense of life purpose?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

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

November 7, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2024

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

November 7, 2022

Last Update Submit

January 21, 2025

Conditions

Resilience

Keywords

Mind-body therapiesResiliencePrisonersMeditation

Outcome Measures

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

    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

    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

    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

    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

    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.

    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

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

Study Arms (1)

Mind-Body MedicineTraining

EXPERIMENTAL

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

Behavioral: Mind-Body Medicine Training Program

Interventions

Mind-Body Medicine Training ProgramBEHAVIORAL

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.

Mind-Body MedicineTraining

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 (1)

Indiana Department of Correction

Indianapolis, Indiana, 46204, 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
OTHER
Intervention Model
SINGLE GROUP
Model Details: Non-controlled repeated measures
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 21, 2022

Study Start

November 21, 2022

Primary Completion

February 19, 2024

Study Completion

February 19, 2024

Last Updated

January 23, 2025

Record last verified: 2025-01

Locations

US(1)