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

Depression Clinical Trial

— MOTIVATE_IIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220202
• Other study ID #: IIR 20-256
• Secondary ID: IRB # 1672072
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: September 2023
• Source: VA Office of Research and Development
• Contact: Florine Pore-Brown, BS
• Phone: (214) 857-3291
• Email: florine.pore-brown[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Back Pain
• Chronic Back Pain
• Depression
• Depressive Disorder
• Musculoskeletal Pain

Intervention

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).

Locations

Country	Name	City	State
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Dallas VA Medical Center, Michael E. DeBakey VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months post baseline or completion of MOTIVATE
Secondary	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	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	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	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	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)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	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"	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	FRAIL scale	FRAIL measures frailty among older adults. scoring consist of 5 questions: 1-2+ pre-frail; 3+ frail	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	Anxiety	PROMIS Anxiety short forms will assess anxiety symptoms. scale range 1-5: 1 (never) to 5 (always)	Baseline, Mid (~5 weeks), End (~3 months) and 6 months
Secondary	Therapeutic Alliance	therapeutic alliance assessed using the Working Alliance Inventory Short-Form	Mid (~5 weeks), End (~3 months)