NCT06782503

Brief Summary

The goal of this study is to evaluate the effectiveness of a mind-body medicine training program on parole services staff. The main questions it aims to answer are:

  • Will participation in the training increase resilience; empathy; the belief that one can cope with difficult situations; and decrease symptoms of depression, stress, anxiety, and burnout?
  • What is the personal and professional impact of the training program? Sixty staff members of the Indiana Department of Correction Parole Services Division will do the following:
  • Attend an initial 4-day mind-body medicine training. Mind-body techniques taught in the training include: meditation; a breathing exercise; biofeedback; guided imagery; expressing oneself through drawings and writing; movement to reduce stress; and family trees to explore family dynamics.
  • Attend a 2-day practicum. The 2-day practicum will teach staff the ways in which they can share the skills they have learned one-on-one with parolees and families of parolees.
  • Attend 4 biweekly sessions of 2-hour group consultation sessions. The consultations will support the use of the mind-body skills with the parolees. Participants will also do the following:
  • Fill out standardized questionnaires online before and after the training program in order to measure changes in resilience; empathy; the belief that one can cope with difficult situations; and symptoms of depression, stress, anxiety, and burnout.
  • Fill out an additional online questionnaire three months after the consultation sessions to determine how trainees are using the mind-body skills in their work.
  • Participate in an online group interview to determine how trainees are using the skills and how the training has affected them personally and professionally.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

January 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 21, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

January 15, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

ResilienceEmpathyBurnoutStressMeditationMind-body therapies

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline on Resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC) after the 4-day training and 3 months after the last group consultation session

    Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC). The CD-RISC consists of 25 questions that are rated on a 5-point scale, with higher scores representing greater resilience. Change = (Score after the 4-day training) minus (Baseline score); (Score 3 months after the last group consultation session) minus (Score after the 4-day training); and (Score 3 months after the last group consultation session) minus (Baseline score)

    Baseline, after the 4-day training, and 3 months after the last group consultation session

Secondary Outcomes (4)

  • Change from Baseline on Coping Self-efficacy assessed using the Coping Self-Efficacy Scale (CSE scale) after the 4-day training and 3 months after the last group consultation session

    Baseline, after the 4-day training, and 3 months after the last group consultation session

  • Change from Baseline on Empathy will be assessed using the Toronto Empathy Questionnaire (TEQ) after the 4-day training and 3 months after the last group consultation

    Baseline, after the 4-day training, and 3 months after the last group consultation session

  • Change from Baseline on Depression, Anxiety, and Stress using the Depression Anxiety and Stress Scale -21 (DASS-21) after the 4-day training and 3 months after the last group consultation session

    Baseline, after the 4-day training, and 3 months after the last group consultation session

  • Change from Baseline Burnout using the Oldenburg Burnout Inventory (OLBI) after the 4-day training and 3 months after the last group consultation session

    Baseline, after the 4-day training, and 3 months after the last group consultation session

Other Outcomes (1)

  • Focus Group for Parole Staff Who Are Using Mind-Body Skills with Their Supervised Parolees

    3 months after the last consultation group

Study Arms (1)

Mind-Body MedicineTraining/Practicum/Group Consultation Sessions

OTHER

The only arm is a mind-body medicine training program for parole staff. The training program consists of 3 parts: 1. An initial 4-day training; 2. A 2-day practicum; and 3. Four group consultation sessions. .

Other: Mind-Body Medicine Training Program

Interventions

The 4-day training includes lectures and small group participation. Lecture topics cover information on a variety of mind--body techniques and the small groups allow participants to practice the techniques. The 2-day practicum will teach staff the ways in which they can share the skills they have learned one-on-one with parolees and families of parolees. The practicum lectures will provide a review of the mind-body skills and examples of practical applications. The practicum will also include breakout sessions to allow participants to practice their skills. The four 2-hour group consultation sessions will allow time for the trained staff to share their experiences as they teach these skills to others and ask any questions that may arise. These consultations will support the ongoing sharing of mind-body medicine skills with the parolees and the families of parolees. Edit

Mind-Body MedicineTraining/Practicum/Group Consultation Sessions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a staff member of the Division of Parole Services
  • English Speaking
  • Being 18 years of age or older
  • Able to fully participate in the training and the small groups included in the training

You may not qualify if:

  • None: It is expected that all parole staff will be able to fully participate in the training and the small groups included in the training
  • Completion of the Mind-Body Medicine Training
  • Currently supervising parolees
  • Teaching or using mind-body skills with their supervised parolees
  • Being 18 years of age or older
  • English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana Department of Correction

Indianapolis, Indiana, 46204, United States

Location

Related Publications (5)

  • Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

    PMID: 16004657BACKGROUND
  • Demerouti E, Mostert K, Bakker AB. Burnout and work engagement: a thorough investigation of the independency of both constructs. J Occup Health Psychol. 2010 Jul;15(3):209-222. doi: 10.1037/a0019408.

    PMID: 20604629BACKGROUND
  • Spreng RN, McKinnon MC, Mar RA, Levine B. The Toronto Empathy Questionnaire: scale development and initial validation of a factor-analytic solution to multiple empathy measures. J Pers Assess. 2009 Jan;91(1):62-71. doi: 10.1080/00223890802484381.

    PMID: 19085285BACKGROUND
  • Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S. A validity and reliability study of the coping self-efficacy scale. Br J Health Psychol. 2006 Sep;11(Pt 3):421-37. doi: 10.1348/135910705X53155.

    PMID: 16870053BACKGROUND
  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

    PMID: 12964174BACKGROUND

Related Links

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

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, The Center for Mind-Body Medicine

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 20, 2025

Study Start

January 21, 2025

Primary Completion

February 24, 2025

Study Completion

February 24, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Only IPD used in the results in the publication

Shared Documents
STUDY PROTOCOL
Time Frame
January 2028 - no end date
Access Criteria
Any researcher may request the de-identified IPD from the corresponding author and it will be provided by email.

Locations