NCT03322202

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

November 16, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

3.5 years

First QC Date

October 23, 2017

Last Update Submit

October 9, 2020

Conditions

Keywords

Spinal Cord InjuryMotivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • Increased therapy participation

    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

    4 weeks

Secondary Outcomes (3)

  • Treatment Satisfaction

    4 weeks

  • Self-care and mobility

    4 weeks

  • Efficacy of Motivational Interviewing (MI) Training

    4 weeks

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Physical and Occupational Therapists will have 16 hours of training in Motivational Interviewing and use these techniques during sessions with patients.

Behavioral: Motivational Interviewing

Control

NO INTERVENTION

Therapists will not participate in additional training.

Interventions

Motivational Interviewing is a communication style that is intended to give patients the tools to reach goals through their own desires and actions.

Motivational Interviewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient therapist specializing in spinal cord injury patients for at least 3 months
  • Practicing on one of the two designated inpatient units
  • Willing to collect Patient Rehabilitation Participation Scale (PRPS) daily on their patients
  • Willing to audio record conversations with patients;
  • Willing and able to participate in 16 hours of MI training
  • Willing to receive feedback on MI skills

You may not qualify if:

  • Inpatient therapist specializing in spinal cord injury patients for less than 3 months
  • Unwilling or unable to follow the study protocol
  • Inpatient in the spinal cord injury unit
  • Has a physical or occupational therapist who is a participant in the study
  • Unwilling to allow for therapy sessions to be recorded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan Abilitylab

Chicago, Illinois, 60611, United States

Location

Related Publications (29)

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    PMID: 23318034BACKGROUND
  • 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: 15031821BACKGROUND
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    PMID: 10641802BACKGROUND
  • 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.

    BACKGROUND
  • 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: 20667432BACKGROUND
  • 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: 23379265BACKGROUND
  • 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: 9749693BACKGROUND
  • 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: 17303766BACKGROUND
  • 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: 20696695BACKGROUND
  • 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: 24942478BACKGROUND
  • 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: 21272712BACKGROUND
  • 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: 17258218BACKGROUND
  • 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: 23279630BACKGROUND
  • 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: 22584283BACKGROUND
  • 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: 15389135BACKGROUND
  • 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: 25642584BACKGROUND
  • 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.

    PMID: 22704048BACKGROUND
  • 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.

    BACKGROUND
  • 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: 20013760BACKGROUND
  • 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: 15723728BACKGROUND
  • 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.

    PMID: 22385872BACKGROUND
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    BACKGROUND
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    PMID: 11005395BACKGROUND
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    PMID: 24042990BACKGROUND
  • 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: 15468017BACKGROUND
  • 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: 15612851BACKGROUND
  • 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: 20576715BACKGROUND
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    PMID: 20053272BACKGROUND
  • 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.

    PMID: 19602916BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Linda Ehrlich-Jones, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director of Center for Rehabilitation Outcomes Research

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 26, 2017

Study Start

November 16, 2017

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations