Behavioral Intervention for Chronic Lower Back Pain

Recruiting at 1 trial location

Overseen By Monica Marroquin, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Cognitive impairment, Recent lumbar surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 10-20 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The overarching goal of this study is to evaluate a tele-based behavioral change intervention for older adults (aged 50 years and older) with chronic low back pain (cLBP) and comorbid depression, and to ultimately assess its effect on cLBP-related disability and depressive symptoms. Investigators will conduct a pilot randomized control trial to assess feasibility for older adults with chronic low back pain and depression to receive a behavioral change tele-based intervention delivered by a health coach trained in motivational interviewing. All participants, regardless of intervention arm assigned, will undergo outcomes assessments (baseline, mid-point, final assessments) conducted by a blinded research assistant.

Research Team

Una Makris, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

The MOTIVATE trial is for English-speaking adults aged 50 or older who have chronic lower back pain with an intensity of at least 4 out of 10, experience daily activity interference due to back pain, and also suffer from depression. Participants must be able to engage in home-based activities and have a working telephone.

Inclusion Criteria

I have had lower back pain that affects my daily activities for the past 3 months.

My depression is stable, with a PHQ-9 score over 10, and I don't have thoughts of harming myself or others.

I am 50 years old or older.

Exclusion Criteria

You have thought about hurting yourself or have been in the hospital for serious mental health problems in the past year.

I rely on a wheelchair, am bed-bound, or have severe balance issues.

No telephone

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive a tele-based behavioral change intervention delivered by a health coach over 10-20 weeks

10-20 weeks

8 sessions (tele-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including semi-structured interviews and outcome assessments

6 months

3 outcome assessments (tele-based), 1 interview (tele-based)

Treatment Details

Interventions

• Behavioral Intervention Group

Trial Overview This study tests a tele-based behavioral change intervention for reducing disability and depressive symptoms related to chronic low back pain in older adults. A health coach will deliver the program using motivational interviewing techniques over the phone.

Participant Groups

Group I: Behavioral Intervention Group Experimental Treatment 1 Intervention

For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant.

Group II: Waitlist Control Group Active Control 1 Intervention

The waitlist control group will continue with management of chronic back pain and depression per usual care. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+