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| ID | Type | Description | Link |
|---|---|---|---|
| 973467 | Other Grant/Funding Number | Craig H. Neilsen Foundation |
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| Name | Class |
|---|---|
| Baylor Research Institute | OTHER |
| University of Washington | OTHER |
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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:
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:
Patient participants will:
We plan to conduct a multi-site randomized controlled trial of motivational interviewing (MI) training for physical therapists (PTs) and occupational therapists (OTs) who treat people with SCI during inpatient rehabilitation. We will test whether patients treated by MI trained PTs and OTs demonstrate greater participation in therapy sessions and better functional, social, and educational/occupational outcomes relative to patients treated by therapists without MI training. This stage of research is appropriate because a Neilsen Foundation funded pilot study that we recently completed had promising results. Study results showed that SCI patients treated by MI trained PTs and OTs participated significantly more actively in therapy sessions compared to controls. However, the study had several limitations that need to be addressed to produce a more definitive and influential trial. First, the study was conducted at a single site and results may not generalize to other sites. Second, we did not examine whether MI training and improved participation resulted in patients having better clinically meaningful outcomes such as higher likelihood of discharge to home or superior functional, social, or educational/occupational outcomes. Third, therapists trained in MI achieved only minimal competency in MI skills. We hypothesize that if therapists received ongoing coaching to improve their MI skills during the trial the positive impact on patient participation and other outcomes might be even more robust.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group: Motivational Interviewing | Experimental | 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. |
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| Control Group: Standard Care | No Intervention | Therapists in this group will not participate in additional training and provide standard care to enrolled patient participants. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral | Motivational Interviewing is an evidence-based counseling style that aims to foster positive health behavior change in patients through their desires and actions. |
| Measure | Description | Time Frame |
|---|---|---|
| Therapy Participation Level | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Motivational Interviewing (MI) Training | 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. |
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Therapist Inclusion Criteria:
Therapist Exclusion Criteria:
Patient Inclusion Criteria:
Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Ehrlich-Jones, PhD, RN | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26874558 | Background | 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. | |
| 11392867 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2024 | Feb 5, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Form for Therapist Participant | Dec 12, 2024 | Jan 8, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Form for Patient Participant | Dec 12, 2024 | Jan 8, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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Patients in the experimental group will receive treatment from a Physical or Occupational Therapist trained in Motivational Interviewing. Those in the control group will receive standard therapy communication.
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Patient participants and the assessor rating participation level during therapy sessions will be blinded. Therapist participants will be aware of the arm in which they will be placed through training on motivational interviewing.
| During 1 year of inpatient rehabilitation |
| Functional Abilities | 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 | 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 |
| Baylor Scott & White Institute for Rehabilitation | Recruiting | Dallas | Texas | 75246 | United States |
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| University of Washington - Harborview Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
|
| 22385839 | Background | 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. |
| Background | Miller WR, Rollnick S. Motivational Interviewing: Helping People Change. Third ed. New York, NY: The Guilford Press; 2013. |
| 22385872 | Background | 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. |
| 30577900 | Background | 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. |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |