Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-04-11 @ 11:54 PM
Study NCT ID:
NCT06782503
Status:
TERMINATED
Last Update Posted:
2025-12-10
First Post:
2025-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of a Mind-Body Medicine Training Program for Parole Services Division Staff
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Non-controlled repeated measures'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Lack of interest by parole division in continuing training.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Focus Group for Parole Staff Who Are Using Mind-Body Skills with Their Supervised Parolees', 'timeFrame': '3 months after the last consultation group', 'description': '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.'}], 'primaryOutcomes': [{'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', 'timeFrame': 'Baseline, after the 4-day training, and 3 months after the last group consultation session', 'description': '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.\n\nChange = (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)'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'Baseline, after the 4-day training, and 3 months after the last group consultation session', 'description': '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.\n\nChange = (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)'}, {'measure': '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', 'timeFrame': 'Baseline, after the 4-day training, and 3 months after the last group consultation session', 'description': '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.\n\nChange = (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)'}, {'measure': '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', 'timeFrame': 'Baseline, after the 4-day training, and 3 months after the last group consultation session', 'description': '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.\n\nChange = (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)'}, {'measure': 'Change from Baseline Burnout using the Oldenburg Burnout Inventory (OLBI) after the 4-day training and 3 months after the last group consultation session', 'timeFrame': 'Baseline, after the 4-day training, and 3 months after the last group consultation session', 'description': '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.\n\nChange = (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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resilience', 'Empathy', 'Burnout', 'Stress', 'Meditation', 'Mind-body therapies'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '16004657', 'type': 'BACKGROUND', 'citation': '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': '20604629', 'type': 'BACKGROUND', 'citation': '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': '19085285', 'type': 'BACKGROUND', 'citation': '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': '16870053', 'type': 'BACKGROUND', 'citation': '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': '12964174', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://cmbm.org/work-with-us/training/', 'label': 'This page describes The Center for Mind-Body Medicine Training Program'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* 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?\n* What is the personal and professional impact of the training program?\n\nSixty staff members of the Indiana Department of Correction Parole Services Division will do the following:\n\n* 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.\n* 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.\n* Attend 4 biweekly sessions of 2-hour group consultation sessions. The consultations will support the use of the mind-body skills with the parolees.\n\nParticipants will also do the following:\n\n* 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.\n* 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.\n* Participate in an online group interview to determine how trainees are using the skills and how the training has affected them personally and professionally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Mind-Body Medicine Training :\n\n* Being a staff member of the Division of Parole Services\n* English Speaking\n* Being 18 years of age or older\n* Able to fully participate in the training and the small groups included in the training\n\nExclusion Criteria for Mind-Body Medicine Training:\n\n• 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\n\nInclusion Criteria for Focus Group Participation :\n\n* Completion of the Mind-Body Medicine Training\n* Currently supervising parolees\n* Teaching or using mind-body skills with their supervised parolees\n* Being 18 years of age or older\n* English speaking.\n\nExclusion Criteria for Focus Group Participation:\n\n• None, as long as the trained staff meet the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT06782503', 'briefTitle': 'An Evaluation of a Mind-Body Medicine Training Program for Parole Services Division Staff', 'organization': {'class': 'OTHER', 'fullName': 'The Center for Mind-Body Medicine'}, 'officialTitle': 'An Evaluation of a Mind-Body Medicine Training Program for Parole Services Division Staff', 'orgStudyIdInfo': {'id': 'CMBMIndianaPrisons003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mind-Body MedicineTraining/Practicum/Group Consultation Sessions', 'description': '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. .', 'interventionNames': ['Other: Mind-Body Medicine Training Program']}], 'interventions': [{'name': 'Mind-Body Medicine Training Program', 'type': 'OTHER', 'description': '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.\n\nEdit', 'armGroupLabels': ['Mind-Body MedicineTraining/Practicum/Group Consultation Sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46204', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Department of Correction', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Julie K Staples, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Center for Mind-Body Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'January 2028 - no end date', 'ipdSharing': 'YES', 'description': 'Only IPD used in the results in the publication', 'accessCriteria': 'Any researcher may request the de-identified IPD from the corresponding author and it will be provided by email.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Center for Mind-Body Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herbert Simon Family Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director, The Center for Mind-Body Medicine', 'investigatorFullName': 'Julie K. Staples', 'investigatorAffiliation': 'The Center for Mind-Body Medicine'}}}}