NCT07298941

Resilience Enhancement Following Sleep Treatment

An Adaptive Intervention to Improve Pain Outcomes Following Cognitive Behavioral Therapy for Insomnia in Patients With Comorbid Chronic Low Back Pain and Insomnia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of an adaptive intervention targeting both insomnia and positive affect in improving pain outcomes for adults with chronic low back pain (cLBP) and comorbid insomnia. Specifically, the study tests whether augmenting a cognitive behavioral therapy for insomnia (CBTi) program with a meditation intervention (Savoring Meditation) or a Pain Education intervention will result in greater reductions in pain intensity. Secondary objectives include evaluating improvements in insomnia severity, positive and negative affect, and overall quality of life.

Conditions

• Chronic Low Back Pain (CLBP)
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-behavioral therapy for insomnia (CBTi)	Sleep Healthy Using the Internet (SHUTi) is a 9-week self-guided, automated, internet-based program that is tailored to the individual and designed to recapitulate the core features of face-to-face CBTi (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention). It is fully accessible as a web-based application via computers, tablets, and smartphones.
BEHAVIORAL	CBTi + Savoring Meditation	After first completing CBTi, participants will then complete a course of Savoring Meditation, a meditation training program focused on generating and maintaining positive emotions. Savoring Meditation training comprises four 30-minute training sessions (20-minute meditation training and 10 minutes for Q\&A and session debrief), and will be delivered 1-on-1 by a trained interventionist over remote video-conference.
BEHAVIORAL	CBTi + Pain Education	After first completing the full course of CBTi, participants will then complete a Pain Education intervention. Delivered 1-on-1 via telehealth, patients will be introduced to the biopsychosocial model of pain, through which they will learn about 1) biological bases for low back pain and chronic pain in general, 2) psychological and 3) social processes that influence pain perception, and 4) pain self-management strategies that are supported by scientific evidence. Pain Education training comprises four 30-minute training sessions.

Timeline

• Start date: 2025-12-16
• Primary completion: 2029-10-30
• Completion: 2030-04-30
• First posted: 2025-12-23
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States