Cognitive Behavioral Therapy for Chronic Lower Back Pain
(REST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment approach for adults with chronic lower back pain lasting at least three months, who also struggle with insomnia. It aims to determine if adding meditation or pain education to cognitive behavioral therapy for insomnia (CBTi) can more effectively reduce pain intensity. Participants will first undergo CBTi and then be randomly assigned to either a meditation or pain education program. Ideal participants experience significant distress from both chronic back pain and insomnia, affecting daily life. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially effective solutions.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if your medication use for sleep, pain, or other reasons has changed in the past 3 months, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cognitive-behavioral therapy for insomnia (CBTi) is generally safe and manageable. Studies have found that CBTi can improve sleep quality and efficiency without major side effects. People with chronic pain, such as chronic lower back pain, have experienced better sleep results with CBTi.
For those considering combining CBTi with savoring meditation, studies indicate that both mindfulness practices and CBT can safely enhance pain and function in adults with chronic pain. Many participants report significant improvements without serious side effects.
The combination of CBTi with pain education is also under study. Research suggests that learning about pain can enhance the benefits of CBTi, leading to better pain management while remaining safe for participants.
Overall, these treatments focus on changing behaviors and providing education, which typically carry fewer risks compared to medical treatments. Participants generally tolerate them well, and serious side effects are rare.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Cognitive Behavioral Therapy for Insomnia (CBTi) for managing chronic lower back pain because it addresses sleep issues that often exacerbate pain. Unlike typical pain management options, such as medications and physical therapy, CBTi focuses on improving sleep patterns, which can lead to better pain management outcomes. Moreover, the addition of Savoring Meditation or Pain Education to CBTi offers unique approaches to further enhance relaxation and pain coping strategies, potentially providing a more holistic and sustainable management plan for chronic pain sufferers.
What evidence suggests that this trial's treatments could be effective for chronic lower back pain?
Research has shown that Cognitive Behavioral Therapy for Insomnia (CBTi), which participants in this trial may receive, can significantly reduce pain for individuals with chronic pain. Studies have found that it enhances sleep quality and alleviates insomnia, both crucial for managing chronic pain. In this trial, some participants will receive CBTi combined with Savoring Meditation, which may further aid pain management by increasing mindfulness. Others will receive CBTi paired with Pain Education, helping individuals understand and manage their pain more effectively, leading to reduced pain. Together, these methods offer promising approaches to addressing chronic low back pain and improving overall quality of life.23678
Who Is on the Research Team?
Patrick Finan, Ph.D.
Principal Investigator
University of Virginia School of Medicine
Are You a Good Fit for This Trial?
Adults over 18 with chronic lower back pain for at least 3 months and insomnia symptoms for over 6 months can join this trial. They must have significant pain (4/10 or more) and sleep issues that affect daily life. People with other primary chronic pains or conditions affecting participation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Cognitive Behavioral Therapy for Insomnia (CBTi) with possible augmentation by Savoring Meditation or Pain Education
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CBTi + Pain Education
- CBTi + Savoring Meditation
- Cognitive-behavioral therapy for insomnia (CBTi)
Trial Overview
The study is testing if adding Savoring Meditation or Pain Education to cognitive-behavioral therapy for insomnia (CBTi) helps reduce pain intensity in adults with both chronic low back pain and insomnia, compared to CBTi alone.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Open label CBTi followed by random allocation to Savoring Meditation
Open Label CBTi
Open label CBTi followed by random allocation to Pain Education
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Citations
The effectiveness of pain neuroscience education in ...
Conclusions: PNE decreases pain intensity in CNLBP, with improved outcomes when combined with physiotherapy, exercise, or additional educational ...
Pain Management Skills vs. CBT for Chronic Low Back Pain
Meaning For patients with chronic low back pain, a single-session pain relief skills class showed comparable efficacy to CBT in pain ...
Effect of Cognitive Behavioral Therapy on Chronic Low ...
The main objectives of the study are: To find the efficacy of using cognitive behavioural therapy on chronic low back pain with central ...
CBT + Physical Therapy for Chronic Low Back Pain Outcomes
CBT combined with physical therapy resulted in greater enhancements in pain relief, psychological status, kinesiophobia, and daily functioning in patients with ...
Effectiveness of communicative and educative strategies in ...
Pain science education, graded exposure and multimodal interventions are the most effective for behavior modification and compliance with exercise.
Mindfulness vs Cognitive Behavioral Therapy for Chronic ...
In this large trial, CLBP-related symptoms improved, while opioid dosage decreased in both MBT and CBT groups at 6 and 12 months.
Long-term results of an intensive cognitive behavioral pain ...
Conclusion. Selected and motivated patients with longstanding CLBP improve fast after an intensive combined physical and psychological program ...
Effectiveness of a pain neuroscience education programme ...
Our study aims to assess the effectiveness of a pain neuroscience education programme compared with traditional back school on physical activity.
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