Behavioral Intervention for Chronic Lower Back Pain

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if telephone-based coaching (a behavioral intervention) can help older adults with chronic lower back pain and depression improve their daily lives. Participants will either receive the coaching immediately or continue with their usual care and receive the coaching later. The trial focuses on how this approach might reduce pain-related disabilities and depressive symptoms. It is suitable for those aged 50 and older who experience frequent disruptions in daily activities due to back pain and also suffer from depression. As an unphased trial, this study offers participants a unique opportunity to explore innovative ways to manage their symptoms and enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this behavioral intervention is safe for older adults with chronic low back pain and depression?

Research has shown that treatments focusing on behavior are generally safe for people with chronic low back pain. Studies have found that therapies like cognitive behavioral therapy (CBT) can safely reduce pain and improve daily activities. Specifically, CBT has lowered pain levels and enhanced movement in those with chronic low back pain.

Combining psychological treatments with other therapies, such as physical therapy, has also proven effective without causing harm. Mindfulness-based therapy is another approach linked to better pain management and improved function, and it is considered safe.

Overall, these behavioral treatments for chronic low back pain are well-tolerated. Past patients have experienced positive results without major side effects, making them a safe choice for managing pain in older adults with chronic low back pain and depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this behavioral intervention for chronic lower back pain because it offers a unique approach compared to traditional treatments like medication, physical therapy, or surgery. Unlike these standard options, this intervention uses trained health coaches to deliver therapy via telephone, making it accessible and convenient for participants. The focus is on modifying behaviors and coping strategies, which can empower patients to manage their pain more effectively and potentially lead to longer-lasting results without the side effects associated with medication.

What evidence suggests that this behavioral intervention is effective for chronic low back pain and depression?

Research has shown that certain behavioral treatments can help manage chronic low back pain (CLBP). This trial will compare a Behavioral Intervention Group with a Waitlist Control Group. Studies have found that methods like cognitive behavioral therapy (CBT) and mindfulness, which are part of the behavioral interventions being tested, reduce pain and improve daily functioning. Specifically, mindfulness and CBT have shown promise in treating ongoing CLBP, aiding in pain relief and enhancing quality of life. Evidence suggests these approaches can be more effective than simply waiting for the pain to improve on its own. Overall, these treatments aim to help individuals manage pain better and lead more active lives. ^{1 2 6 7 8}

Who Is on the Research Team?

Una Makris, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7065591/

Behavioural treatment for chronic low‐back pain - PMC For patients with CLBP, there is moderate quality evidence that in the short‐term, operant therapy is more effective than waiting list and behavioural therapy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9529058/

Evidence-based interventions to treat chronic low back pain Effective behavioral treatments include cognitive behavioral therapy, mindfulness-based treatments, and acceptance and commitment therapy.

3. pcori.org pcori.org/research-results/2016/comparing-two-therapy-programs-help-patients-manage-chronic-low-back-pain-stamp-study

Comparing Two Therapy Programs to Help Patients ... The research team wanted to learn if MBT worked better than CBT to help adults reduce chronic low back pain and improve their ability to do daily activities.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2665991325000645

Long-term effectiveness of non-surgical interventions for ... An inception cohort study of 406 people with chronic low back pain found that nearly two-thirds still had pain and disability at 1 year after onset.8 Many ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... Results of the study suggest that both treatments have potential utility in treating adults with refractory CLBP and improving pain, function, and quality-of- ...

6. bmj.com bmj.com/content/376/bmj-2021-067718

Psychological interventions for chronic, non-specific low ... For people with chronic, non-specific low back pain, psychological interventions are most effective when delivered in conjunction with physiotherapy care.

7. hdsr.mitpress.mit.edu hdsr.mitpress.mit.edu/pub/9c034nf7

A Series of Virtual Interventions for Chronic Lower Back Pain The current study evaluated the feasibility and acceptability of a series of personalized (N-of-1) interventions for virtual delivery of massage and yoga or ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000123

Strategies for combining interventional and behavioral ... A recent review examining the effectiveness of cognitive behavioral therapy (CBT) in patients with CLBP showed improvements in pain intensity and disability as ...