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

VA Office of Research and Development

Status: Enrolling

Conditions: Musculoskeletal Pain; Aging; Chronic Back Pain; Depression

Treatments: Behavioral: Behavioral Intervention Group (MOTIVATE)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05220202

IRB # 1672072

IIR 20-256

Details and patient eligibility

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.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 60 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 2 patient groups

Waitlist Control Group

No Intervention group

Description:

The waitlist control group will continue with usual care management of musculoskeletal pain and depression. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, midpoint, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the intervention once they have completed the end outcomes assessment.

Behavior Intervention Group (MOTIVATE)

Experimental group

Description:

For participants assigned to the intervention arm, trained health coaches will deliver the 8 session intervention via telephone. MOTIVATE users motivational interviewing techniques, values elicitation and physical activity based goal setting. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, midpoint, final assessments) conducted by a blinded research assistant.

Treatment:

Behavioral: Behavioral Intervention Group (MOTIVATE)