- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06782503
An Evaluation of a Mind-Body Medicine Training Program for Parole Services Division Staff
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46204
- Indiana Department of Correction
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for Mind-Body Medicine Training :
- 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
Exclusion Criteria for Mind-Body Medicine Training:
• 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
Inclusion Criteria for Focus Group Participation :
- 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.
Exclusion Criteria for Focus Group Participation:
• None, as long as the trained staff meet the inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Mind-Body MedicineTraining/Practicum/Group Consultation Sessions
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. .
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: Baseline, 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: Baseline, after the 4-day training, and 3 months after the last group consultation session
|
Improvements in self-efficacy will be measured using the Coping Self-Efficacy Scale (CSE scale). The CSE scale consists of 26 items that are rated using an 11-point scale that ranges from "0 = Cannot do at all" to "10 = Certain can do". Higher scores indicate greater levels of coping self-efficacy. 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
|
|
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
Time Frame: Baseline, after the 4-day training, and 3 months after the last group consultation session
|
Improvements in empathy will be measured using the Toronto Empathy Questionnaire (TEQ). The TEQ scale consists of 16 items that are rated using a 5-point scale that ranges from "0 = never" to "4 = always. Higher scores indicate higher levels of empathy. 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
|
|
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
Time Frame: Baseline, after the 4-day training, and 3 months after the last group consultation session
|
The DASS - 21 consists of 7 questions each to measure the emotional states of depression, anxiety, and stress. Higher scores indicated higher levels of depression, anxiety and stress. 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
|
|
Change from Baseline Burnout using the Oldenburg Burnout Inventory (OLBI) after the 4-day training and 3 months after the last group consultation session
Time Frame: Baseline, after the 4-day training, and 3 months after the last group consultation session
|
Decreases in burnout will be measured with Oldenburg Burnout Inventory (OLBI). The OLBI consists of 16-items that are rated using a 4-point scale that ranges from "1= strongly agree" to "4 = strongly disagree". There are two subscales: Exhaustion and Disengagement. Higher scores indicated greater levels of burnout. 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Focus Group for Parole Staff Who Are Using Mind-Body Skills with Their Supervised Parolees
Time Frame: 3 months after the last consultation group
|
Focus group interviews determine will how parole staff have been using what was taught in the mind-body medicine training and how the training has affected them, their work, and their supervision of parolees.
|
3 months after the last consultation group
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Julie K Staples, PhD, The Center for Mind-Body Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMBMIndianaPrisons003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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