MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
Recruiting · NCT05220202 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
Behavioral Intervention Group (MOTIVATE)
What this trial is about
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.
Who can take part
Age range
60 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed across 1 US state.
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX - Dallas, Texas, United States
- Michael E. DeBakey VA Medical Center, Houston, TX - Houston, Texas, United States