Mindfulness vs Cognitive Behavioral Therapy for Chronic Pain

(B-MORE v B-CBT Trial)

Overseen By Adam Hanley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Cancer, Unstable illness, Recent surgery, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two approaches to help adults manage chronic pain: Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) and Brief Cognitive-Behavioral Therapy (B-CBT). Both treatments are short and straightforward, focusing on improving pain management through mindfulness techniques or cognitive strategies. The trial is suitable for individuals dealing with chronic pain who can speak English or Spanish fluently. Participants should not have prior formal training in these therapies and should not have had recent surgery or pain-relief injections. The study aims to find effective ways to reduce pain and improve the quality of life for those with ongoing pain issues. As an unphased trial, it offers an opportunity to explore innovative pain management techniques that could enhance quality of life.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

What prior data suggests that these behavioral interventions are safe for chronic pain?

Research has shown that both Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) and Brief Cognitive-Behavioral Therapy (B-CBT) are safe for individuals with chronic pain. Studies on B-MORE have found it effective and manageable, particularly for veterans with chronic pain, with no serious side effects reported.

Similarly, researchers have tested B-CBT in veterans with chronic pain, finding it safe and manageable, even for those at risk of suicide. These studies noted no harmful effects, and participants generally responded well to the therapy. Both treatments aim to help individuals manage pain without medication, offering low-risk options for those seeking alternative pain relief methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new approaches to managing chronic pain without relying solely on medication. Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) integrates mindfulness practices to help patients focus on the present moment and reframe their pain experience, potentially reducing reliance on painkillers. Meanwhile, Brief Cognitive-Behavioral Therapy (B-CBT) employs cognitive strategies to alter pain perception and improve coping mechanisms. Unlike traditional pain management options like opioids or long-term psychological therapy, these brief interventions are designed to be more accessible and may offer quicker relief with fewer side effects.

What evidence suggests that this trial's treatments could be effective for chronic pain?

This trial will compare two treatments for chronic pain: Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) and Brief Cognitive-Behavioral Therapy (B-CBT). Studies have shown that Mindfulness-Oriented Recovery Enhancement (MORE) can improve pain management and quality of life for people with chronic pain through mindfulness techniques. One study found that MORE was especially helpful for individuals with chronic pain who also faced opioid misuse issues. Similarly, Brief Cognitive-Behavioral Therapy (B-CBT) has shown promise in managing chronic pain by helping individuals change their thoughts about pain, reducing discomfort. A review of studies found that B-CBT improved the ability to handle pain, making daily activities easier. Both treatments have shown positive results, offering hope for those dealing with chronic pain. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with chronic pain who are comfortable with English or Spanish. It's not clear what specific conditions exclude someone from participating, as the exclusion criteria were not provided.

Inclusion Criteria

Understanding English or Spanish instructions fluently

I have a long-term pain condition.

My average pain level was over 3 last week.

Exclusion Criteria

Unstable illness that may interfere with treatment

I am unable to give consent due to physical or mental reasons.

I have completed training in mindfulness or CBT.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) or Brief Cognitive-Behavioral Therapy (B-CBT) for chronic pain

12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at 2, 6, and 12 weeks post-treatment

Optional Neuroimaging Session

Spanish-speaking participants may participate in optional EEG and fNIRS neuroimaging sessions

After study completion

What Are the Treatments Tested in This Trial?

Interventions

• Brief Cognitive-Behavioral Therapy
• Brief Mindfulness-Oriented Recovery Enhancement

Trial Overview The study is testing two short-term treatments for chronic pain: Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) and Brief Cognitive-Behavioral Therapy (B-CBT). Participants will be randomly assigned to one of these approaches.

How Is the Trial Designed?

Group I: Brief Behavioral Intervention #2 Experimental Treatment 1 Intervention

Brief Cognitive-Behavioral Therapy (B-CBT)

Group II: Brief Behavioral Intervention #1 Experimental Treatment 1 Intervention

Brief Mindfulness Oriented Recovery Enhancement (B-MORE)

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31318726/

Brief Cognitive Behavioral Therapy For Chronic Pain The aim of this project was to collect preliminary effectiveness data for Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04724694

Brief Cognitive Behavioral Therapy for Chronic Pain to ... Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas ...

3. scholars.uthscsa.edu scholars.uthscsa.edu/en/publications/brief-cognitive-behavioral-therapy-for-chronic-pain-results-from-

Brief cognitive behavioral therapy for chronic pain The aim of this project was to collect preliminary effectiveness data for Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) ...

4. va.gov va.gov/PAINMANAGEMENT/CBT_CP/docs/Brief_CBT-CP-Manual-V2_5-6-2021.pdf

Brief Cognitive Behavioral Therapy for Chronic Pain Our hope is that by offering Brief CBT-CP, the overarching goal of improving. Veteran outcomes through chronic pain self-management will be met ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1200685/full

A systematic review of cognitive behavioral therapy-based ... One out of one study (100%) identified significant differences in improved pain-related disability at post-treatment with a small effect size (d ...

6. va.gov va.gov/painmanagement/docs/cbt-cp_therapist_manual.pdf

Cognitive Behavioral Therapy for Chronic Pain Short- and long-term efficacy of brief cognitive-behavioral therapy for patients with chronic temporomandibular disorder pain: A randomized, controlled trial.

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

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... MBT and CBT were associated with safe improvements in pain and functional outcomes among adults affected with refractory, complex, opioid- ...

8. cfha.net cfha.net/wp-content/uploads/2024/06/9a.-BCBT-CP-DoD-Manual_20240520.pdf

Brief Cognitive Behavioral Therapy for Chronic Pain Use of brief validated measures to capture patient-reported outcomes (e.g., routine assessment of pain intensity, distress, functional interference, and others) ...

9. academic.oup.com academic.oup.com/milmed/article/190/7-8/1629/7923186

Safety and Tolerability of a Brief Cognitive-Behavioral Therapy ... Brief CBT-CP appears to be a safe and well-tolerated treatment for Veterans with chronic noncancer pain who are also at risk for suicide.