NCT05220202 MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
| NCT ID | NCT05220202 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Chronic Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2023-09-20 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 264 participants in total. It began in 2023-09-20 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.
Eligibility Criteria
Inclusion Criteria: * Aged 60 and older * English- speaking * Self-reported MSK pain (include cLBP +/- radiating symptoms, OA, fibromyalgia) on most days for the past 3 months that interferes with daily activities * Pain intensity that is 4+/10 on the numerical pain rating scale * Pain interference threshold 5+ on PEG-3 * Depressive symptoms, 10+ on PHQ-9 * Capable of participating in home-based activity * Interested in participating in a non-pharmacologic program Exclusion Criteria: * Aged 59 or less * No telephone * Not English speaking * Unwilling to be randomized to either study arm * Not interested in participating in a non-pharmacologic program * Self-reported uncorrected hearing and visual impairments precluding ability to participate in telephone sessions or read pedometer screen * Significant (moderate or severe) cognitive impairment (3+ errors) on six-item screening exam * Self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe OA\* (resulting in inability to participate in physical activity intervention) * Illness requiring hospitalization within the last 3 months that interferes with a home-based physical activity intervention (e.g., fall, gout attack, stroke, heart attack, heart failure, surgery for blocked arteries) * Suicidal intent (see suicide screening protocol), uncontrolled psychotic disorder or psychiatric hospitalization within 1 year, or enrolled in active substance use program (confirmed with scripted protocol over telephone)
Contact & Investigator
Una E. Makris, MD MSc
PRINCIPAL INVESTIGATOR
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Frequently Asked Questions
Who can join the NCT05220202 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 99 Years, studying Chronic Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05220202 currently recruiting?
Yes, NCT05220202 is actively recruiting participants. Contact the research team at florine.pore-brown@va.gov for enrollment information.
Where is the NCT05220202 trial being conducted?
This trial is being conducted at Dallas, United States, Houston, United States.
Who is sponsoring the NCT05220202 clinical trial?
NCT05220202 is sponsored by VA Office of Research and Development. The principal investigator is Una E. Makris, MD MSc at VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX. The trial plans to enroll 264 participants.