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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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).

Первичные конечные точки

• Primary Outcome: Pain interference [Срок оценки: 3 months post baseline or completion of MOTIVATE]

Вторичные конечные точки (12)

• Depressive symptoms, PHQ-9 [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Arthritis self-efficacy [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Pain Catastrophizing [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Psychological resilience [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Pain Behavior [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Quality of Life using PROMIS Global Health Scale [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Social Functioning [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Sleep Disturbance [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Insomnia Severity Index [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Patient Global Impression of change scale [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• FRAIL scale [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
• Anxiety [Срок оценки: Baseline, Mid (~5 weeks), End (~3 months) and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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