Spinal Cord InjuriesNCT03322202
Training Therapists in Motivational Interviewing
A study testing Motivational Interviewing in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2017to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Therapist Inclusion Criteria:
- 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
Therapist Exclusion Criteria:
- Inpatient therapist specializing in spinal cord injury patients for less than 3 months
- Unwilling or unable to follow the study protocol
Patient Inclusion Criteria:
- Inpatient in the spinal cord injury unit
- Has a physical or occupational therapist who is a participant in the study
Patient Exclusion Criteria:
- Unwilling to allow for therapy sessions to be recorded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training Therapists in Motivational Interviewing to Enhance Rehabilitation Participation for Spinal Cord Injury (SCI)
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Motivational Interviewing
- Keywords
- Spinal Cord Injury, Motivational Interviewing
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Motivational Interviewing is a communication style that is intended to give patients the tools to reach goals through their own desires and actions.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Physical and Occupational Therapists will have 16 hours of training in Motivational Interviewing and use these techniques during sessions with patients. Receives: Behavioral: Motivational Interviewing |
| Control | No intervention | Therapists will not participate in additional training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (3)
Treatment Satisfaction
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
Measured: 4 weeks
Self-care and mobility
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
Measured: 4 weeks
Efficacy of Motivational Interviewing (MI) Training
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start16 Nov 2017
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Linda Ehrlich-Jones, Shirley Ryan AbilityLab
- Investigators
- Linda Ehrlich-Jones, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322202
- Sponsor's protocol ID
- 441247
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23318034Lenze 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.
PubMed 15031821Maclean 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.
PubMed 10641802Lundahl 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.
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.
PubMed 20667432Bombardier 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.
PubMed 23379265Bombardier 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.
PubMed 9749693Watkins 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.
PubMed 17303766Ehrlich-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.
PubMed 20696695O'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.
PubMed 24942478Vong 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.
PubMed 21272712Brodie 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.
PubMed 17258218Tse 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.
PubMed 23279630Cowan 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.
PubMed 22584283Pellatt 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.
PubMed 15389135
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Therapists in Motivational Interviewing to Enhance Rehabilitation Participation for Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT03322202
- Acronym / sponsor ID
- 441247
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingPhysical and Occupational Therapists will have 16 hours of training in Motivational Interviewing and use these techniques during sessions with patients. |
| Control | No intervention | –Therapists will not participate in additional training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivational Interviewing is a communication style that is intended to give patients the tools to reach goals through their own desires and actions. | Behavioural | Motivational Interviewing |
Primary outcome
Increased therapy participation
Time frame: 4 weeks
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
3 secondary outcomes
Treatment Satisfaction
Time frame: 4 weeks
Self-care and mobility
Time frame: 4 weeks
Efficacy of Motivational Interviewing (MI) Training
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 23318034Teeter 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.
- Background: PubMed 15031821Lenze 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.
- Background: PubMed 10641802Maclean 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.
- BackgroundLundahl 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: PubMed 20667432Soderlund 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.
- Background: PubMed 23379265Bombardier 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.
- Background: PubMed 9749693Bombardier 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.
- Background: PubMed 17303766Watkins 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.
- Background: PubMed 20696695Ehrlich-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.
- Background: PubMed 24942478O'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.
- Background: PubMed 21272712Vong 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.
- Background: PubMed 17258218Brodie 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.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Recruiting
A Neuroprosthesis for Seated Posture and Balance
Spinal Cord Injury, Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Ehrlich-Jones, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased therapy participation (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03322202, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.