What side effects are associated with this type of intervention?

Mindfulness-based interventions for chronic pain, such as mindfulness meditation and mindfulness-based stress reduction, are generally safe with minimal side effects, though some individuals may experience increased anxiety or emotional discomfort initially. Other non-pharmacologic treatments like progressive muscle relaxation and guided imagery are also low-risk but can occasionally cause temporary discomfort. In contrast, pharmacologic treatments like opioids carry significant risks, including addiction, tolerance, constipation, and potential overdose, while antidepressants may cause nausea, dizziness, dry mouth, and weight gain.

What prior FDA approvals exist?

FDA-approved treatments for chronic pain include various pharmacologic agents such as antidepressants (e.g., duloxetine, venlafaxine), antiepileptics (e.g., gabapentin, pregabalin), and opioids (e.g., tramadol). These medications target different mechanisms of pain relief, including neuropathic pain and fibromyalgia. While mindfulness-based interventions like MBSR (Mindfulness-Based Stress Reduction) are not pharmacologic, they complement these treatments by enhancing emotional regulation and awareness, potentially reducing the need for higher doses of medications and improving overall pain management.

What other types of research exist?

Promising alternatives to Mindfulness-Based Interventions for chronic pain management include: 1) Guided Imagery and Progressive Muscle Relaxation, which have shown effectiveness in reducing pain and improving psychological well-being; 2) Cognitive Behavioral Therapy (CBT), which has demonstrated efficacy in managing chronic pain and associated psychological distress; 3) Acupuncture and Acupressure, which may provide pain relief and improve overall function; 4) Biofeedback, which can help patients gain control over physiological functions to reduce pain; and 5) Music Therapy, which has been beneficial in reducing pain and improving mood in chronic pain patients.

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Behavioral Intervention

Mindfulness Therapy for Chronic Pain

N/A

Waitlist Available

Research Sponsored by Canandaigua VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 years and older

English-speaking veterans

Must not have

Uncontrolled medical conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months post-treatment follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy combining mindfulness and cognitive techniques to help veterans with chronic pain and suicidal thoughts. The therapy aims to reduce pain and improve mood by focusing on the present moment and changing negative thoughts.

Who is the study for?

This trial is for English-speaking veterans, aged 18 or older, who understand the study and have chronic pain affecting their daily life. They must also be at risk of suicide, either having suicidal thoughts recently, a history of such ideation in the past few months, or an attempt within the last six months.

What is being tested?

The study is testing Mindfulness-Based Cognitive Therapy (MBCT) to see if it helps reduce problems caused by chronic pain and lowers suicide risk compared to standard Health Education.

What are the potential side effects?

Mindfulness interventions are generally considered safe but may sometimes lead to discomfort when confronting difficult emotions or memories. Health education has no known side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a veteran and I speak English.

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I have experienced pain on most days for the last six months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled medical conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months post-treatment follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months post-treatment follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months post-treatment follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Depression

Interpersonal Needs

Pain Interference and intensity

+2 more

Secondary study objectives

Fear of pain

Health-related Quality of Life

Mindfulness

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-Based Cognitive Therapy (MBCT)Experimental Treatment1 Intervention

MBCT delivered over the course of 10, \~60 minute sessions

Group II: Health EducationActive Control1 Intervention

Health education sessions delivered over the course of 10, \~60 minute sessions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness-Based Cognitive Therapy (MBCT)

2014

N/A

~180

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic pain, such as acceptance and commitment therapy (ACT), cognitive behavioral therapy (CBT), and mindfulness-based stress reduction (MBSR), primarily work by enhancing emotional regulation, increasing awareness, and promoting adaptive coping strategies. ACT helps patients accept pain and commit to living a meaningful life despite it, while CBT focuses on changing negative thought patterns that exacerbate pain. MBSR uses mindfulness meditation to increase awareness and reduce stress. These mechanisms are crucial for chronic pain patients as they address the psychological and emotional aspects of pain, which can significantly improve quality of life and reduce the risk of associated issues like anxiety, depression, and even suicide.

Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.Acceptance and commitment therapy for chronic pain: evidence of mediation and clinically significant change following an abbreviated interdisciplinary program of rehabilitation.