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Recruiting NCT05220202

MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression

No phase Interventional Chronic Back Pain Depression Aging Musculoskeletal Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral Intervention Group (MOTIVATE).
Who it may be relevant to
Registry conditions: Chronic Back Pain, Depression, Aging, Musculoskeletal Pain. Basic parameters: 60 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Behavioral Intervention Group (MOTIVATE)
    Behavioral: 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).

Primary outcome measures

  • Primary Outcome: Pain interference [Time frame: 3 months post baseline or completion of MOTIVATE]
Secondary outcome measures (12)
  • Depressive symptoms, PHQ-9 [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Arthritis self-efficacy [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Pain Catastrophizing [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Psychological resilience [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Pain Behavior [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Quality of Life using PROMIS Global Health Scale [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Social Functioning [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Sleep Disturbance [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Insomnia Severity Index [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Patient Global Impression of change scale [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • FRAIL scale [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
  • Anxiety [Time frame: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 2 centers
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas
  • Michael E. DeBakey VA Medical Center, Houston, TX — Houston

Identifiers

NCT: NCT05220202 · IIR 20-256 · IRB # 1672072

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗