Improving outcomes for older veterans with musculoskeletal pain and depression
MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
This study tests a new program to see if it can help older veterans with chronic pain and depression feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 60 Years to 99 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT05220202 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and implementation of MOTIVATE, a behavioral intervention designed for older Veterans suffering from chronic musculoskeletal pain and depressive symptoms. Conducted as a randomized controlled trial at two major VA facilities, the research aims to determine how well this remotely delivered program can improve patient-centered outcomes. The study focuses on older Veterans aged 60 and above who experience significant pain and depression, assessing both the intervention's impact and its scalability for broader use.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans aged 60 and older who experience chronic musculoskeletal pain and have comorbid depressive symptoms.
Not a fit: Patients who are younger than 60, do not speak English, or have severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for older Veterans by alleviating pain and depressive symptoms.
How similar studies have performed: Other studies have shown promise with behavioral interventions for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Dallas, Texas and 1 other locations
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (Recruiting)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Una E. Makris, MD MSc — VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
- Study coordinator: Florine Pore-Brown, BS
- Email: florine.pore-brown@va.gov
- Phone: (214) 857-3291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.