Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-06 @ 1:34 PM
Study NCT ID:
NCT03322202
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training Therapists in Motivational Interviewing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patient participants will be blinded as will an assessor measuring participation during sessions. Therapist participants will be aware of the arm in which they will be placed.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients in the experimental group will be exposed to a Physical or Occupational Therapist trained in Motivational Interviewing. The control group will receive standard therapy communication.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-09', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increased therapy participation', 'timeFrame': '4 weeks', 'description': 'To measure therapy participation in inpatients with SCI treated by rehabilitation therapists trained in Motivational Interviewing (MI) compared to those treated by therapists not trained to use MI'}], 'secondaryOutcomes': [{'measure': 'Treatment Satisfaction', 'timeFrame': '4 weeks', 'description': 'To measure treatment satisfaction in inpatients with SCI treated by rehabilitation therapists trained in MI compared to those treated by therapists not trained to use MI'}, {'measure': 'Self-care and mobility', 'timeFrame': '4 weeks', 'description': 'To measure Inpatient Rehabilitation Facility (IRF)-Patient Assessment Instrument (PAI) efficiency in the domains of self-care and mobility in inpatients with SCI treated by rehabilitation therapists trained in MI compared to those treated by therapists not trained to use MI'}, {'measure': 'Efficacy of Motivational Interviewing (MI) Training', 'timeFrame': '4 weeks', 'description': 'To measure the efficacy of MI training by measuring adherence to MI counseling skills in rehabilitation therapists trained to use MI compared to those not trained to use MI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal Cord Injury', 'Motivational Interviewing'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '23318034', 'type': 'BACKGROUND', 'citation': 'Teeter L, Gassaway J, Taylor S, LaBarbera J, McDowell S, Backus D, Zanca JM, Natale A, Cabrera J, Smout RJ, Kreider SE, Whiteneck G. Relationship of physical therapy inpatient rehabilitation interventions and patient characteristics to outcomes following spinal cord injury: the SCIRehab project. J Spinal Cord Med. 2012 Nov;35(6):503-26. doi: 10.1179/2045772312Y.0000000058.'}, {'pmid': '15031821', 'type': 'BACKGROUND', 'citation': 'Lenze EJ, Munin MC, Quear T, Dew MA, Rogers JC, Begley AE, Reynolds CF 3rd. The Pittsburgh Rehabilitation Participation Scale: reliability and validity of a clinician-rated measure of participation in acute rehabilitation. Arch Phys Med Rehabil. 2004 Mar;85(3):380-4. doi: 10.1016/j.apmr.2003.06.001.'}, {'pmid': '10641802', 'type': 'BACKGROUND', 'citation': 'Maclean N, Pound P. A critical review of the concept of patient motivation in the literature on physical rehabilitation. Soc Sci Med. 2000 Feb;50(4):495-506. doi: 10.1016/s0277-9536(99)00334-2.'}, {'type': 'BACKGROUND', 'citation': 'Lundahl B, Kunz C, Brownell C, Tollefson D, Burke B. A meta-analysis of motivational interviewing: Twenty-five years of empirical studies. Research on Social Work Practice. 2010;20(2):137-160.'}, {'pmid': '20667432', 'type': 'BACKGROUND', 'citation': 'Soderlund LL, Madson MB, Rubak S, Nilsen P. A systematic review of motivational interviewing training for general health care practitioners. Patient Educ Couns. 2011 Jul;84(1):16-26. doi: 10.1016/j.pec.2010.06.025. Epub 2010 Jul 25.'}, {'pmid': '23379265', 'type': 'BACKGROUND', 'citation': 'Bombardier CH, Ehde DM, Gibbons LE, Wadhwani R, Sullivan MD, Rosenberg DE, Kraft GH. Telephone-based physical activity counseling for major depression in people with multiple sclerosis. J Consult Clin Psychol. 2013 Feb;81(1):89-99. doi: 10.1037/a0031242.'}, {'pmid': '9749693', 'type': 'BACKGROUND', 'citation': 'Bombardier CH, Rimmele CT. Alcohol use and readiness to change after spinal cord injury. Arch Phys Med Rehabil. 1998 Sep;79(9):1110-5. doi: 10.1016/s0003-9993(98)90180-0.'}, {'pmid': '17303766', 'type': 'BACKGROUND', 'citation': 'Watkins CL, Auton MF, Deans CF, Dickinson HA, Jack CI, Lightbody CE, Sutton CJ, van den Broek MD, Leathley MJ. Motivational interviewing early after acute stroke: a randomized, controlled trial. Stroke. 2007 Mar;38(3):1004-9. doi: 10.1161/01.STR.0000258114.28006.d7. Epub 2007 Feb 15.'}, {'pmid': '20696695', 'type': 'BACKGROUND', 'citation': 'Ehrlich-Jones L, Mallinson T, Fischer H, Bateman J, Semanik PA, Spring B, Ruderman E, Chang RW. Increasing physical activity in patients with arthritis: a tailored health promotion program. Chronic Illn. 2010 Dec;6(4):272-81. doi: 10.1177/1742395309351243. Epub 2010 Aug 9.'}, {'pmid': '24942478', 'type': 'BACKGROUND', 'citation': "O'Halloran PD, Blackstock F, Shields N, Holland A, Iles R, Kingsley M, Bernhardt J, Lannin N, Morris ME, Taylor NF. Motivational interviewing to increase physical activity in people with chronic health conditions: a systematic review and meta-analysis. Clin Rehabil. 2014 Dec;28(12):1159-71. doi: 10.1177/0269215514536210. Epub 2014 Jun 18."}, {'pmid': '21272712', 'type': 'BACKGROUND', 'citation': 'Vong SK, Cheing GL, Chan F, So EM, Chan CC. Motivational enhancement therapy in addition to physical therapy improves motivational factors and treatment outcomes in people with low back pain: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):176-83. doi: 10.1016/j.apmr.2010.10.016.'}, {'pmid': '17258218', 'type': 'BACKGROUND', 'citation': 'Brodie DA, Inoue A, Shaw DG. Motivational interviewing to change quality of life for people with chronic heart failure: a randomised controlled trial. Int J Nurs Stud. 2008 Apr;45(4):489-500. doi: 10.1016/j.ijnurstu.2006.11.009. Epub 2007 Jan 26.'}, {'pmid': '23279630', 'type': 'BACKGROUND', 'citation': 'Tse MM, Vong SK, Tang SK. Motivational interviewing and exercise programme for community-dwelling older persons with chronic pain: a randomised controlled study. J Clin Nurs. 2013 Jul;22(13-14):1843-56. doi: 10.1111/j.1365-2702.2012.04317.x. Epub 2013 Jan 2.'}, {'pmid': '22584283', 'type': 'BACKGROUND', 'citation': 'Cowan RE, Nash MS, Anderson KD. Exercise participation barrier prevalence and association with exercise participation status in individuals with spinal cord injury. Spinal Cord. 2013 Jan;51(1):27-32. doi: 10.1038/sc.2012.53. Epub 2012 May 15.'}, {'pmid': '15389135', 'type': 'BACKGROUND', 'citation': 'Pellatt GC. Patient-professional partnership in spinal cord injury rehabilitation. Br J Nurs. 2004 Sep 9-22;13(16):948-53. doi: 10.12968/bjon.2004.13.16.15966.'}, {'pmid': '25642584', 'type': 'BACKGROUND', 'citation': 'Wiprovnick AE, Kuerbis AN, Morgenstern J. The effects of therapeutic bond within a brief intervention for alcohol moderation for problem drinkers. Psychol Addict Behav. 2015 Mar;29(1):129-35. doi: 10.1037/a0038489. Epub 2015 Feb 2.'}, {'pmid': '22704048', 'type': 'BACKGROUND', 'citation': 'Zuckoff A. "Why won\'t my patients do what\'s good for them?" Motivational interviewing and treatment adherence. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):514-21. doi: 10.1016/j.soard.2012.05.002. Epub 2012 May 4.'}, {'type': 'BACKGROUND', 'citation': "Pegg PO, Auerbach SM, Kiesler DJ, Plybon LE, Seel RT, Buenaver LF. The Impact of Patient-Centered Information on Patients' Treatment Satisfaction and Outcomes in Traumatic Brain Injury Rehabilitation. Rehabilitation Psychology. 2005;50(4):366-374."}, {'pmid': '20013760', 'type': 'BACKGROUND', 'citation': 'Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010 May-Jun;17(3):231-9. doi: 10.1002/cpp.658.'}, {'pmid': '15723728', 'type': 'BACKGROUND', 'citation': 'Moyers TB, Martin T, Manuel JK, Hendrickson SM, Miller WR. Assessing competence in the use of motivational interviewing. J Subst Abuse Treat. 2005 Jan;28(1):19-26. doi: 10.1016/j.jsat.2004.11.001.'}, {'pmid': '22385872', 'type': 'BACKGROUND', 'citation': 'Miller WR, Rollnick S. Meeting in the middle: motivational interviewing and self-determination theory. Int J Behav Nutr Phys Act. 2012 Mar 2;9:25. doi: 10.1186/1479-5868-9-25. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Velasquez M, Maurer G, Crouch C, DiClemente C. Group treatment for substance abuse: A stages of change therapy book. New York: Guilford Press; 2001.'}, {'pmid': '11005395', 'type': 'BACKGROUND', 'citation': 'Mead N, Bower P. Patient-centredness: a conceptual framework and review of the empirical literature. Soc Sci Med. 2000 Oct;51(7):1087-110. doi: 10.1016/s0277-9536(00)00098-8.'}, {'pmid': '24042990', 'type': 'BACKGROUND', 'citation': 'Lindberg J, Kreuter M, Person LO, Taft C. Patient Participation in Rehabilitation Questionnaire (PPRQ)-development and psychometric evaluation. Spinal Cord. 2013 Nov;51(11):838-42. doi: 10.1038/sc.2013.98. Epub 2013 Sep 17.'}, {'pmid': '15468017', 'type': 'BACKGROUND', 'citation': 'Lenze EJ, Munin MC, Quear T, Dew MA, Rogers JC, Begley AE, Reynolds CF. Significance of poor patient participation in physical and occupational therapy for functional outcome and length of stay. Arch Phys Med Rehabil. 2004 Oct;85(10):1599-601. doi: 10.1016/j.apmr.2004.03.027.'}, {'pmid': '15612851', 'type': 'BACKGROUND', 'citation': 'Miller WR, Yahne CE, Moyers TB, Martinez J, Pirritano M. A randomized trial of methods to help clinicians learn motivational interviewing. J Consult Clin Psychol. 2004 Dec;72(6):1050-62. doi: 10.1037/0022-006X.72.6.1050.'}, {'pmid': '20576715', 'type': 'BACKGROUND', 'citation': 'Hall AM, Ferreira PH, Maher CG, Latimer J, Ferreira ML. The influence of the therapist-patient relationship on treatment outcome in physical rehabilitation: a systematic review. Phys Ther. 2010 Aug;90(8):1099-110. doi: 10.2522/ptj.20090245. Epub 2010 Jun 24.'}, {'pmid': '20053272', 'type': 'BACKGROUND', 'citation': 'Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.'}, {'pmid': '19602916', 'type': 'BACKGROUND', 'citation': 'Mohr DC, Spring B, Freedland KE, Beckner V, Arean P, Hollon SD, Ockene J, Kaplan R. The selection and design of control conditions for randomized controlled trials of psychological interventions. Psychother Psychosom. 2009;78(5):275-84. doi: 10.1159/000228248. Epub 2009 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the efficacy of a Motivational Interviewing intervention on therapy participation as performed by physical and occupational therapists in an inpatient setting with patients with spinal cord injuries.', 'detailedDescription': 'Physical and Occupational Therapists that work in the inpatient spinal cord injury unit will be trained in Motivational Interviewing and will use the communication style to determine whether it is an effective tool to increase participation in therapy as opposed to patients who will have Physical and Occupational Therapists that are not trained in Motivational Interviewing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Therapist Inclusion Criteria:\n\n* Inpatient therapist specializing in spinal cord injury patients for at least 3 months\n* Practicing on one of the two designated inpatient units\n* Willing to collect Patient Rehabilitation Participation Scale (PRPS) daily on their patients\n* Willing to audio record conversations with patients;\n* Willing and able to participate in 16 hours of MI training\n* Willing to receive feedback on MI skills\n\nTherapist Exclusion Criteria:\n\n* Inpatient therapist specializing in spinal cord injury patients for less than 3 months\n* Unwilling or unable to follow the study protocol\n\nPatient Inclusion Criteria:\n\n* Inpatient in the spinal cord injury unit\n* Has a physical or occupational therapist who is a participant in the study\n\nPatient Exclusion Criteria:\n\n* Unwilling to allow for therapy sessions to be recorded'}, 'identificationModule': {'nctId': 'NCT03322202', 'briefTitle': 'Training Therapists in Motivational Interviewing', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Training Therapists in Motivational Interviewing to Enhance Rehabilitation Participation for Spinal Cord Injury (SCI)', 'orgStudyIdInfo': {'id': '441247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing', 'description': 'Physical and Occupational Therapists will have 16 hours of training in Motivational Interviewing and use these techniques during sessions with patients.', 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Therapists will not participate in additional training.'}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'Motivational Interviewing is a communication style that is intended to give patients the tools to reach goals through their own desires and actions.', 'armGroupLabels': ['Motivational Interviewing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Shirley Ryan Abilitylab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Linda Ehrlich-Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Craig H. Neilsen Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Director of Center for Rehabilitation Outcomes Research', 'investigatorFullName': 'Linda Ehrlich-Jones', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}