Clinical trial NCT05220202: MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
Official title: MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Back Pain
Depression
Aging
Musculoskeletal Pain
Keywords: Chronic Back Pain
Depression
Veterans
Aging
Musculoskeletal Pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Dallas VA Medical Center
name: Michael E. DeBakey VA Medical Center
First posted: 2022-02-02
Enrollment: 264
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This Randomized Clinical Trial will randomize to either MOTIVATE or a waitlist control
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Investigators will conduct a randomized controlled trial (RCT) at two large VA facilities, to establish the effectiveness and scalability of MOTIVATE, a remotely delivered behavioral intervention for older Veterans with comorbid musculoskeletal (MSK) pain and depressive symptoms. The central hypothesis is that MOTIVATE will improve important patient-centered outcomes among older Veterans with co-occurring MSK pain and 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)

Primary outcomes:
measure: Primary Outcome: Pain interference
timeFrame: 3 months post baseline or completion of MOTIVATE
Secondary outcomes:
measure: Depressive symptoms, PHQ-9
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Arthritis self-efficacy
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Pain Catastrophizing
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Psychological resilience
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Pain Behavior
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Quality of Life using PROMIS Global Health Scale
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Social Functioning
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Sleep Disturbance
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Insomnia Severity Index
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Patient Global Impression of change scale
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: FRAIL scale
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Anxiety
timeFrame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months
measure: Therapeutic Alliance
timeFrame: Mid (~5 weeks), End (~3 months)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
name: Una E. Makris, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: