- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364773
Enhancing Rehabilitation Participation in Patients With SCI/D Using Motivational Interviewing
Enhancing Rehabilitation Participation in Patients With Spinal Cord Injury or Disorder Using Motivational Interviewing
The purpose of this multi-site clinical trial is to see whether people with spinal cord injury or disorder (SCI/D) demonstrate higher level of participation in rehabilitation sessions and other outcomes when their therapists are trained in a counseling style called motivational interviewing. We want to answer the following questions:
- Do inpatients with SCI/D treated by physical therapists (PTs) and occupational therapists (OTs) who receive MI training and coaching demonstrate greater therapy participation compared to those treated by therapists who do not receive MI training and coaching?
- Do inpatients with SCI/D treated by PTs and OTs who receive MI training and coaching demonstrate greater functional improvement at discharge from inpatient rehabilitation and greater community integration at 6 months after discharge compared to those treated by therapists who do not receive MI training and coaching?
- What are the potential moderators and mediators of the effect of training and coaching on MI skills on therapy participation?
Researchers will compare patient participation level and other outcomes of inpatients with SCI/D treated by PTs and OTs who receive MI training and coaching with those treated by therapists who do not receive MI training and coaching.
Therapist participants will:
- Audio record 2 therapy sessions per week with each enrolled SCI patient participant
- Half of the therapists will attend a 16-hour training on MI skills and 2 practice therapy session
Patient participants will:
- Consent to audio recording of their therapy sessions
- Complete one brief survey near the time of their discharge and another survey 6 months later
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Shirley Ryan AbilityLab
-
Contact:
- My Le
- Phone Number: 3122388253
- Email: mle@sralab.org
-
Contact:
- Jenny Burns
- Email: jburns03@sralab.org
-
Principal Investigator:
- Linda Ehrlich-Jones, PhD, RN
-
-
Texas
-
Dallas, Texas, United States, 75246
- Recruiting
- Baylor Scott & White Institute for Rehabilitation
-
Contact:
- Dannae Arnold
- Phone Number: 214-820-9663
- Email: Dannae.Arnold@BSWHealth.org
-
Principal Investigator:
- Dannae Arnold, PT, DPT, ATP
-
-
Washington
-
Seattle, Washington, United States, 98104
- Recruiting
- University of Washington - Harborview Medical Center
-
Principal Investigator:
- Charles Bombardier, PhD
-
Contact:
- Charles Bombardier, PhD
- Phone Number: 206-744-4607
- Email: chb@uw.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Therapist Inclusion Criteria:
- Inpatient therapist specializing in spinal cord injury patients for at least 3 months;
- Practicing at the designated SCI inpatient units at Shirley Ryan AbilityLab, Baylor Scott & White Institute for Rehabilitation and University of Washington-Harborview Medical Center;
- Willing to audio record conversations during regularly-scheduled rehabilitation therapy sessions with patients;
- Willing and able to participate in 16 hours of MI training; and
- Willing to receive feedback on MI skills.
Therapist Exclusion Criteria:
- Inability to speak and understand English
- Inpatient therapist specializing in spinal cord injury patients for less than 3 months; and
- Unwilling or unable to follow the study protocol
Patient Inclusion Criteria:
- Adults (18+)
- Presence of a traumatic or non-traumatic spinal cord injury
- Inpatient in the spinal cord injury unit of the three study sites
- Has a physical or occupational therapist who is a participant in the study
Patient Exclusion Criteria:
- Inability to speak and understand English
- Cognitive deficits
- Unwilling to allow for therapy sessions to be recorded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group: Motivational Interviewing
Physical and Occupational Therapists in this group will receive 16 hours of training in Motivational Interviewing and use these techniques during sessions with enrolled patient participants.
|
Motivational Interviewing is an evidence-based counseling style that aims to foster positive health behavior change in patients through their desires and actions.
|
|
No Intervention: Control Group: Standard Care
Therapists in this group will not participate in additional training and provide standard care to enrolled patient participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Therapy Participation Level
Time Frame: From enrollment to the end of 4-week treatment
|
A blinded assessor will use the Pittsburgh Rehabilitation Participation Scale (PRPS) to measure therapy participation in inpatients with SCI treated by therapists trained in Motivational Interviewing (MI) compared to those treated by therapists not trained to use MI.
The PRPS rating ranges from 1 (none) to 6 (excellent), with higher scores indicating higher level of participation
|
From enrollment to the end of 4-week treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of Motivational Interviewing (MI) Training
Time Frame: During 1 year of inpatient rehabilitation
|
We will use the Motivational Interviewing Treatment Integrity (MITI) to continually evaluate 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.
The ratings are on a 5-point Likert scale from 1 (low) to 5 (high), with higher scores indicating higher level of efficacy.
|
During 1 year of inpatient rehabilitation
|
|
Functional Abilities
Time Frame: At week 4
|
The Spinal Cord Injury Functional Independence (SCI-FI) will be administered to patient participants within approximately one week of their discharge from inpatient rehabilitation.
The response scale range from 1 (unable to do the activity) to 5 (no difficulty), with higher scores indicating higher functional ability.
|
At week 4
|
|
Participation in the Community
Time Frame: At 6 months post-discharge
|
The Participation Assessment with Recombined Tools-Objective (PART-O) will be administered to patient participants to measure their level of involvement in the community 6 months post discharge.
Higher scores indicate higher level of participation.
|
At 6 months post-discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linda Ehrlich-Jones, PhD, RN, Shirley Ryan AbilityLab
Publications and helpful links
General Publications
- Bombardier CH, Bell KR, Temkin NR, Fann JR, Hoffman J, Dikmen S. The efficacy of a scheduled telephone intervention for ameliorating depressive symptoms during the first year after traumatic brain injury. J Head Trauma Rehabil. 2009 Jul-Aug;24(4):230-8. doi: 10.1097/HTR.0b013e3181ad65f0.
- 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.
- Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.
- 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.
- 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.
- Moyers TB, Rowell LN, Manuel JK, Ernst D, Houck JM. The Motivational Interviewing Treatment Integrity Code (MITI 4): Rationale, Preliminary Reliability and Validity. J Subst Abuse Treat. 2016 Jun;65:36-42. doi: 10.1016/j.jsat.2016.01.001. Epub 2016 Jan 13.
- Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
- Bombardier CH, Dyer JR, Burns P, Crane DA, Takahashi MM, Barber J, Nash MS. A tele-health intervention to increase physical fitness in people with spinal cord injury and cardiometabolic disease or risk factors: a pilot randomized controlled trial. Spinal Cord. 2021 Jan;59(1):63-73. doi: 10.1038/s41393-020-0523-6. Epub 2020 Jul 21.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lequerica AH, Kortte K. Therapeutic engagement: a proposed model of engagement in medical rehabilitation. Am J Phys Med Rehabil. 2010 May;89(5):415-22. doi: 10.1097/PHM.0b013e3181d8ceb2.
- Deci EL, Ryan RM. Self-determination theory in health care and its relations to motivational interviewing: a few comments. Int J Behav Nutr Phys Act. 2012 Mar 2;9:24. doi: 10.1186/1479-5868-9-24.
- Miller WR, Rollnick S. Motivational Interviewing: Helping People Change. Third ed. New York, NY: The Guilford Press; 2013.
- Kramer Schmidt L, Andersen K, Nielsen AS, Moyers TB. Lessons learned from measuring fidelity with the Motivational Interviewing Treatment Integrity code (MITI 4). J Subst Abuse Treat. 2019 Feb;97:59-67. doi: 10.1016/j.jsat.2018.11.004. Epub 2018 Nov 20.
- Whiteneck GG, Gassaway J, Ketchum JM. Transforming a Traumatic Brain Injury Measure of Participation Into a Psychometrically Sound Spinal Cord Injury Participation Measure. Arch Phys Med Rehabil. 2019 Dec;100(12):2293-2300. doi: 10.1016/j.apmr.2019.06.020. Epub 2019 Aug 14.
- Heinemann AW, Dijkers MP, Ni P, Tulsky DS, Jette A. Measurement properties of the Spinal Cord Injury-Functional Index (SCI-FI) short forms. Arch Phys Med Rehabil. 2014 Jul;95(7):1289-1297.e5. doi: 10.1016/j.apmr.2014.01.031. Epub 2014 Mar 3.
- Ozelie R, Gassaway J, Buchman E, Thimmaiah D, Heisler L, Cantoni K, Foy T, Hsieh CH, Smout RJ, Kreider SE, Whiteneck G. Relationship of occupational therapy inpatient rehabilitation interventions and patient characteristics to outcomes following spinal cord injury: the SCIRehab project. J Spinal Cord Med. 2012 Nov;35(6):527-46. doi: 10.1179/2045772312Y.0000000062.
- Granger CV, Karmarkar AM, Graham JE, Deutsch A, Niewczyk P, Divita MA, Ottenbacher KJ. The uniform data system for medical rehabilitation: report of patients with traumatic spinal cord injury discharged from rehabilitation programs in 2002-2010. Am J Phys Med Rehabil. 2012 Apr;91(4):289-99. doi: 10.1097/PHM.0b013e31824ad2fd.
- Seel RT, Corrigan JD, Dijkers MP, Barrett RS, Bogner J, Smout RJ, Garmoe W, Horn SD. Patient Effort in Traumatic Brain Injury Inpatient Rehabilitation: Course and Associations With Age, Brain Injury Severity, and Time Postinjury. Arch Phys Med Rehabil. 2015 Aug;96(8 Suppl):S235-44. doi: 10.1016/j.apmr.2014.10.027.
- Lequerica AH, Rappor LJ, Whitman R. Psychometric properties of the Rehabilitation Therapy Engagement Scale among patients with acquired brain injury. Rehabil Psychol. 2007;51:331-337.
- Kortte KB, Falk LD, Castillo RC, Johnson-Greene D, Wegener ST. The Hopkins Rehabilitation Engagement Rating Scale: development and psychometric properties. Arch Phys Med Rehabil. 2007 Jul;88(7):877-84. doi: 10.1016/j.apmr.2007.03.030.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Injuries
- Spinal Cord Diseases
- Health Services
- Health Care Facilities Workforce and Services
- Behavioral Disciplines and Activities
- Directive Counseling
- Counseling
- Mental Health Services
- Motivational Interviewing
Other Study ID Numbers
- STU00219326
- 973467 (Other Grant/Funding Number: Craig H. Neilsen Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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