Spinal Cord Injuries (SCI)NCT07364773
Enhancing Rehabilitation Participation in Patients With SCI/D Using Motivational Interviewing
A study testing Motivational Interviewing in people with Spinal Cord Injuries (SCI) and Spinal Cord Disease, run by Shirley Ryan AbilityLab at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI), Spinal Cord Disease
- 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
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2025to 20 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
My Le, 3122388253, mle@sralab.org
Jenny Burns, jburns03@sralab.org
- Recruiting
Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, 75246
Dannae Arnold, 214-820-9663, Dannae.Arnold@BSWHealth.org
Dannae Arnold, PT, DPT, ATP
- Recruiting
University of Washington - Harborview Medical Center
Seattle, Washington, 98104
Charles Bombardier, PhD, 206-744-4607, chb@uw.edu
Charles Bombardier, PhD
About this study
Official title: 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?
Read more
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
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries (SCI), Spinal Cord Disease
- Being tested
- Motivational Interviewing
- Keywords
- Spinal Cord Injury, Spinal Cord Disorder, Motivational Interviewing, Rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Motivational Interviewing is an evidence-based counseling style that aims to foster positive health behavior change in patients through their desires and actions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motivational Interviewing |
| Control Group: Standard Care | No intervention | Therapists in this group will not participate in additional training and provide standard care to enrolled patient participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of 4-week treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Nov 2025
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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 receive treatment from a Physical or Occupational Therapist trained in Motivational Interviewing. Those in the control group will receive standard therapy communication.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor Research Institute, University of Washington
- Responsible party
- Principal investigator, Linda Ehrlich-Jones, PhD, Shirley Ryan AbilityLab
- Investigators
- Linda Ehrlich-Jones, PhD, RN, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364773
- Sponsor's protocol ID
- STU00219326
- Other IDs
- 973467
- Status last verified
- Jan 2026
- First submitted
- 9 Oct 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26874558Ryan 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.
PubMed 11392867Deci 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.
PubMed 22385839Miller WR, Rollnick S. Motivational Interviewing: Helping People Change. Third ed. New York, NY: The Guilford Press; 2013.
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.
PubMed 22385872Kramer 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.
PubMed 30577900Whiteneck 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.
PubMed 31421095Heinemann 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.
PubMed 24602551Miller 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.
PubMed 15612851Bombardier 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.
PubMed 32694748Bombardier 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.
PubMed 19625862O'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 24942478Ehrlich-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 20696695Watkins 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 17303766Bombardier 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 9749693
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Rehabilitation Participation in Patients With Spinal Cord Injury or Disorder Using Motivational Interviewing
- ClinicalTrials.gov ID
- NCT07364773
- Acronym / sponsor ID
- STU00219326
- Conditions
- Spinal Cord Injuries (SCI), Spinal Cord Disease
- Keywords
- Spinal Cord Injury, Spinal Cord Disorder, Motivational Interviewing, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Baylor Research Institute, University of Washington
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 23 Jan 2026 (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 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
Detailed description
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.
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 receive treatment from a Physical or Occupational Therapist trained in Motivational Interviewing. Those in the control group will receive standard therapy communication.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingPhysical 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. |
| Control Group: Standard Care | No intervention | –Therapists in this group will not participate in additional training and provide standard care to enrolled patient participants. |
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 an evidence-based counseling style that aims to foster positive health behavior change in patients through their desires and actions. | Behavioural | Experimental Group: Motivational Interviewing |
Primary outcome
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
3 secondary outcomes
Efficacy of Motivational Interviewing (MI) Training
Time frame: During 1 year of inpatient rehabilitation
Functional Abilities
Time frame: At week 4
Participation in the Community
Time frame: At 6 months post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 26874558Moyers 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.
- Background: PubMed 11392867Ryan 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.
- Background: PubMed 22385839Deci 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.
- BackgroundMiller WR, Rollnick S. Motivational Interviewing: Helping People Change. Third ed. New York, NY: The Guilford Press; 2013.
- Background: PubMed 22385872Miller 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.
- Background: PubMed 30577900Kramer 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.
- Background: PubMed 31421095Whiteneck 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.
- Background: PubMed 24602551Heinemann 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.
- Background: PubMed 15612851Miller 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.
- Background: PubMed 32694748Bombardier 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.
- Background: PubMed 19625862Bombardier 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.
- 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.
- Individual participant dataSharing planned: No
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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.
Baylor Scott & White Institute for Rehabilitation
Dallas, United States
Linda Ehrlich-Jones, PhD, RN principal investigator
Shirley Ryan AbilityLab
3 sites 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 (SCI) and Spinal Cord Disease, run by Shirley Ryan AbilityLab at 3 sites 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapy Participation Level (time frame: From enrollment to the end of 4-week treatment). 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 NCT07364773, which also lists 26 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 23 Jan 2026.