MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-99
SponsorVA Office of Research and Development
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Aged 59 or less
No telephone
Not English speaking
Unwilling to be randomized to either study arm
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral Intervention Group (MOTIVATE)
BehavioralBehavioral: Behavioral Intervention Group (MOTIVATE) The behavioral intervention is designed for older Veterans with musculoskeletal pain and depression and will include 8 individual telephone sessions delivered by health coaches (for up to 5 months total), accounting for additional time between sessions (if needed).
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: Waitlist Control GroupNo intervention 0 interventions
Group B: Behavior Intervention Group (MOTIVATE)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome: Pain interference
Pain interference will be assessed using the interference subscale of the Brief Pain Inventory (BPI) score at 3 months post-baseline or completion of MOTIVATE. Patient-reported pain-related interference (0-10 scale, with higher values indicating more pain) has been shown to be sensitive to change and to have good reliability. A mean between-group difference of 1-point in the primary outcome (change of BPI interference score from baseline to 3 months) is considered a clinically meaningful difference.
Time frame
3 months post baseline or completion of MOTIVATESecondary outcomes
1
Depressive symptoms, PHQ-9
Depressive symptom severity will be assessed using the PHQ-9, a validated 9 question instrument used for monitoring and measuring the severity of depression symptoms. A cutoff score of \>10 signifies clinically meaningful symptom burden
Time frame
Baseline, Mid (~5 weeks), End (~3 months) and 6 months2
Arthritis self-efficacy
Arthritis self-efficacy scale is a 10 point Likert scale that measures the belief or confidence the subject has to perform 8 specific activities or tasks, based on arthritis Scale range 1-10: 1) very uncertain to 10) very certain
Time frame
Baseline, Mid (~5 weeks), End (~3 months) and 6 months3
Pain Catastrophizing
Pain catastrophizing, a prominent pain behavior construct, can influence response to treatment for chronic musculoskeletal pain. Scale range 0-4: 0 (not at all) to 4 (all the time)
Time frame
Baseline, Mid (~5 weeks), End (~3 months) and 6 months4
Psychological resilience
Psychological resilience will be measured by Connor-Davidson Resilience Scale (CD-RISC). scale range 0-4: 0 (not at all) to 4 (all the time)
Time frame
Baseline, Mid (~5 weeks), End (~3 months) and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
Dallas VA Medical Center
Collaborator
Michael E. DeBakey VA Medical Center
Collaborator
Source ClinicalTrials.gov