HealthyNCT06782503
An Evaluation of a Mind-Body Medicine Training Program for Parole Services Division Staff
A study testing Mind-Body Medicine Training Program in people with Healthy, run by The Center for Mind-Body Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mind-Body Medicine Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 24 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Completion of the Mind-Body Medicine Training
- Currently supervising parolees
Show all 9Show fewer
- Teaching or using mind-body skills with their supervised parolees
- Being 18 years of age or older
- English speaking.
Who cannot join
- 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
- None, as long as the trained staff meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Department of Correction
Indianapolis, Indiana, 46204
About this study
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?
Read more
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.
- Conditions
- Healthy
- Being tested
- Mind-Body Medicine Training Program
- Keywords
- Resilience, Empathy, Burnout, Stress, Meditation, Mind-body therapies
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Medicine Training ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: Other: Mind-Body Medicine Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: Baseline, after the 4-day training, and 3 months after the last group consultation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start21 Jan 2025
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Why it stopped: Lack of interest by parole division in continuing training.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-controlled repeated measures
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Mind-Body Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Herbert Simon Family Foundation
- Responsible party
- Principal investigator, Julie K. Staples, The Center for Mind-Body Medicine
- Investigators
- Julie K Staples, PhD, Principal investigator, The Center for Mind-Body Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782503
- Sponsor's protocol ID
- CMBMIndianaPrisons003
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results in the publication
Publications
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.
PubMed 16004657Demerouti 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.
PubMed 20604629Spreng 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.
PubMed 19085285Chesney 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.
PubMed 16870053Connor 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.
PubMed 12964174
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Mind-Body Medicine Training Program for Parole Services Division Staff
- ClinicalTrials.gov ID
- NCT06782503
- Acronym / sponsor ID
- CMBMIndianaPrisons003
- Conditions
- Healthy
- Keywords
- Resilience, Empathy, Burnout, Stress, Meditation, Mind-body therapies
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of interest by parole division in continuing training.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The Center for Mind-Body MedicineUniversity, hospital or other
- Collaborators
- Herbert Simon Family Foundation
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-controlled repeated measures
| Arm | Type | Receives |
|---|---|---|
| Mind-Body MedicineTraining/Practicum/Group Consultation Sessions | Other | Other: Mind-Body Medicine Training ProgramThe 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. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Completion of the Mind-Body Medicine Training
Key exclusion criteria (2 listed)
- 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
- None, as long as the trained staff meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-Body Medicine Training ProgramThe 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 | Other | Mind-Body MedicineTraining/Practicum/Group Consultation Sessions |
Primary outcome
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)
4 secondary outcomes
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
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
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
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
Results and safety
The study was stopped early (reason given: Lack of interest by parole division in continuing training.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Background: PubMed 16004657Henry 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.
- Background: PubMed 20604629Demerouti 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.
- Background: PubMed 19085285Spreng 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.
- Background: PubMed 16870053Chesney 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.
- Background: PubMed 12964174Connor 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.
- This page describes The Center for Mind-Body Medicine Training ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only IPD used in the results in the publication
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie K Staples, PhD principal investigator
The Center for Mind-Body Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Medicine Training Program in people with Healthy, run by The Center for Mind-Body Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of interest by parole division in continuing training.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06782503, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.