MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression - Clinical Trial for Chronic Back Pain | NCT05220202

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral Intervention Group (MOTIVATE)

About this trial

This is an interventional health services research trial for Chronic Back Pain focused on measuring Chronic Back Pain, Depression, Veterans, Aging, Musculoskeletal Pain

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXRecruiting
Michael E. DeBakey VA Medical Center, Houston, TXRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waitlist Control Group

Behavior Intervention Group (MOTIVATE)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Primary Outcome: Pain interference

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

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

Arthritis self-efficacy

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

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

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

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

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

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

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

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)

Patient Global Impression of change scale

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

FRAIL measures frailty among older adults. scoring consist of 5 questions: 1-2+ pre-frail; 3+ frail

Anxiety

PROMIS Anxiety short forms will assess anxiety symptoms. scale range 1-5: 1 (never) to 5 (always)

Therapeutic Alliance

therapeutic alliance assessed using the Working Alliance Inventory Short-Form

Full Information

NCT ID

NCT05220202

First Posted

January 21, 2022

Last Updated

September 21, 2023

Sponsor

VA Office of Research and Development

Collaborators

Dallas VA Medical Center, Michael E. DeBakey VA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05220202

Brief Title

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

Acronym

MOTIVATE_IIR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 20, 2023 (Actual)

Primary Completion Date

October 1, 2026 (Anticipated)

Study Completion Date

December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

Collaborators

Dallas VA Medical Center, Michael E. DeBakey VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Back Pain, Depression, Aging, Musculoskeletal Pain

Keywords

Chronic Back Pain, Depression, Veterans, Aging, Musculoskeletal Pain

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Waitlist Control Group

Arm Type

No Intervention

Arm 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.

Arm Title

Behavior Intervention Group (MOTIVATE)

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Intervention Group (MOTIVATE)

Other Intervention Name(s)

MOTIVATE

Intervention Description

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 Measure Information:

Title

Primary Outcome: Pain interference

Description

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.

Time Frame

3 months post baseline or completion of MOTIVATE

Secondary Outcome Measure Information:

Title

Depressive symptoms, PHQ-9

Description

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

Time Frame