NCT05220202 · VA Office of Research and Development
MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
(MOTIVATE_IIR)
What this study 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Dallas, Texas
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2025 · Source of record for eligibility and locations