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Chronic Back PainMOTIVATE_IIRNCT05220202

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

A study testing Behavioral Intervention Group (MOTIVATE) in people with Chronic Back Pain and Depression, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 99 years
Conditions the study is for
Chronic Back Pain, Depression, Aging
What is being tested?
Behavioral Intervention Group (MOTIVATE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
2 sitesUnited States
Study dates
20 Sep 2023to 9 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English- speaking
  • Self-reported musculoskeletal (MSK) pain (include Chronic low back pain (cLBP) +/- radiating symptoms, osteoarthritis (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 3-item Pain, Enjoyment of Life, and General Activity scale (PEG-3)
  • Depressive symptoms, 10+ on the Patient Health Questionnaire-9 (PHQ-9)
  • Capable of participating in home-based activity
  • Interested in participating in a non-pharmacologic program

Who cannot join

  • 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
Show all 9Show fewer
  • Self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe osteoarthritis (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 locations and contacts

2 sites in 1 country.

United States2 sites

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216-7167

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030-4211

Other trials in United States

About this study

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.

Read the 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.

Being tested
Behavioral Intervention Group (MOTIVATE)
Keywords
Chronic Back Pain, Depression, Veterans, Aging, Musculoskeletal Pain
Medical subject headings
Depression, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral Intervention Group (MOTIVATE)Behavioural

    Also called 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).

Study groups in NCT05220202
Study groupRoleWhat they receive
Waitlist Control GroupNo interventionThe 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)ExperimentalFor 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.
Receives: Behavioral: Behavioral Intervention Group (MOTIVATE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months post baseline or completion of MOTIVATE

Secondary outcomes (11)

  1. 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

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  2. 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

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  3. 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)

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  4. 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)

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  5. 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)

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  6. 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)

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  7. 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)

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  8. 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)

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  9. FRAIL scale

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

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  10. Anxiety

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

    Measured: Baseline, Mid (~5 weeks), End (~3 months) and 6 months

  11. Therapeutic Alliance

    therapeutic alliance assessed using the Working Alliance Inventory Short-Form

    Measured: Mid (~5 weeks), End (~3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start20 Sep 2023
  3. Primary completion9 Jul 2026
  4. Study completion9 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This Randomized Clinical Trial will randomize to either MOTIVATE or a waitlist control
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220202
Sponsor's protocol ID
IIR 20-256
Other IDs
IRB # 1672072
Acronym
MOTIVATE_IIR
Status last verified
Aug 2026
First submitted
21 Jan 2022
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Intervention Group (MOTIVATE) in people with Chronic Back Pain and Depression, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome: Pain interference (time frame: 3 months post baseline or completion of MOTIVATE). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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