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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05220202

Collaborator

Dallas VA Medical Center (U.S. Fed), Michael E. DeBakey VA Medical Center (U.S. Fed)

264

Enrollment

Location

Arms

46.9

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Back Pain Depression Aging Musculoskeletal Pain	Behavioral: Behavioral Intervention Group (MOTIVATE)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

264 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jan 2, 2023

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	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). Other Names: MOTIVATE

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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.

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).

Other Names:

MOTIVATE

Outcome Measures

Primary Outcome Measures

Primary Outcome: Pain interference [3 months post baseline or completion of MOTIVATE]
Pain interference will be assessed using the interference subscale of the Brief Pain Inventory (BPI) score at 3 months post-baseline or completion of MOTIVATE. Patient-reported pain-related interference (0-10 scale, with higher values indicating more pain) has been shown to be sensitive to change and to have good reliability. A mean between-group difference of 1-point in the primary outcome (change of BPI interference score from baseline to 3 months) is considered a clinically meaningful difference.

Secondary Outcome Measures

Depressive symptoms, PHQ-9 [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
Depressive symptom severity will be assessed using the PHQ-9, a validated 9 question instrument used for monitoring and measuring the severity of depression symptoms. A cutoff score of >10 signifies clinically meaningful symptom burden
Physical Activity [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
Physical activity in both arms will be assessed using the Physical Activity Scale for Elderly (PASE), a self-report 12-item scale that includes measures of household and leisure activities.
Arthritis self-efficacy [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
Arthritis self-efficacy scale is a 10 point Likert scale that measures the belief or confidence the subject has to perform 8 specific activities or tasks, based on arthritis Scale range 1-10: 1) very uncertain to 10) very certain
Pain Catastrophizing [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
Pain catastrophizing, a prominent pain behavior construct, can influence response to treatment for chronic musculoskeletal pain. Scale range 0-4: 0 (not at all) to 4 (all the time)
Psychological resilience [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
Psychological resilience will be measured by Connor-Davidson Resilience Scale (CD-RISC). scale range 0-4: 0 (not at all) to 4 (all the time)
Pain Behavior [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
NIH PROMIS short forms, for pain behavior have shown to have excellent psychometric properties in chronic pain. Scale range 1-6: 1 (No pain) to 6 (Always)
Quality of Life using PROMIS Global Health Scale [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
NIH PROMIS short forms, for quality of life (PROMIS Global Health scale (physical and mental health) have shown to have excellent psychometric properties in chronic pain. Scale range 5-1: 5 (Excellent) to 1 (Poor)
Social Functioning [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
NIH PROMIS short forms, for social functioning have shown to have excellent psychometric properties in chronic pain. Scale range 1-5: 1 (Never) to 5 (Always)
Sleep Disturbance [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
8-item PROMIS Sleep disturbance short form is well validated using objective sleep assessment tools (e.g., actigraphy) and used routinely in chronic pain patients and older adults. Scale range 5-1: 5 (very poor) to 1 (very good)
Insomnia Severity Index [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
The 7-item Insomnia severity index (ISI) will assess severity of both nighttime and daytime components of insomnia scale ranges: 0 - 7 No clinically significant insomnia; 8 - 14 Subthreshold insomnia; 15 - 21 Clinical insomnia (moderate severity); 22 - 28 Clinical insomnia (severe)
Pain Intensity [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
Pain intensity numerical rating scale (NRS) 0-10
PEG-3 Pain interference [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
PEG-3, and number/location of pain sites are captured with the BPI
Widespread Pain Inventory [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
Widespread Pain Inventory will assess fibromyalgia. Scoring based on 1-4 scale with total: 0-7 No clinical Insomnia; 8-14 subthreshold insomnia; 15-21 clinical insomnia (moderate severity); 22-28 clinical insomnia (severe)
Patient Global Impression of change scale [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
Patient Global Impression of Change Scale, recommended as a core outcome measure in pain trials, will be assessed. scoring range is 1-7: 1) "no change" to 7) "a great deal better"
FRAIL scale [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
FRAIL measures frailty among older adults. scoring consist of 5 questions: 1-2+ pre-frail; 3+ frail
Anxiety [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
PROMIS Anxiety short forms will assess anxiety symptoms. scale range 1-5: 1 (never) to 5 (always)
Future Time Perspective Scale [Baseline]
Time horizons shape motivational priorities and will be measured using the Future Time Perspective scale
Short Michigan Alcoholism Screening Test [Baseline]
Short Michigan Alcoholism Screening Test will measure substance use
Drug use questionnaire (DAST-10) [Baseline]
Illicit substance use Drug Use Questionnaire (DAST-10)
Cognitive impairment [Baseline]
mild cognitive impairment (MCI) using the telephone Memory Impairment Screen (a brief 4-minute measure, found to have 93% specificity as compared to the Telephone Instrument for Cognitive Status for dementia). Consist of 6 questions: what is the year, month, day; apple, table, penny. The participant is asked to recall and repeat these items a few minutes later.
Healthcare utilization and cost [Baseline, Mid (~5 weeks), End (~3 months) and 6 months]
All VA healthcare utilization including visits (emergency department, hospitalizations, mental health and pain related appointments identified by diagnostic codes and confirmed by chart review) and medication will be abstracted for up to 6 months after randomization.
Therapeutic Alliance [Mid (~5 weeks), End (~3 months)]
therapeutic alliance assessed using the Working Alliance Inventory Short-Form
Physical activity: step counts measured using Omron pedometer. [Through 8 intervention sessions, up to 25 weeks]
Participants will wear the pedometer clipped to their right lateral waistband for 24 hours per day for 7 consecutive days (except during shower or water activities) to obtain 5 complete days of physical activity data

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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)