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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2026-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Back Pain Depression Aging Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This Randomized Clinical Trial will randomize to either MOTIVATE or a waitlist control

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

The research staff conducting outcome assessments will be blinded to whether the subject is in active or waitlist group.

Study Groups

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Waitlist Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Behavior Intervention Group (MOTIVATE)

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.

Group Type EXPERIMENTAL

Behavioral Intervention Group (MOTIVATE)

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Other Intervention Names

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MOTIVATE

Eligibility Criteria

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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)

Minimum Eligible Age

60 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No