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NCT07298941 · ClinicalTrials.gov registry record · Phase 2
Resilience Enhancement Following Sleep Treatment
A Phase 2 study of Insomnia and Chronic Low Back Pain (CLBP), sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT07298941: Recruiting Phase 2 study of Insomnia and Chronic Low Back Pain (CLBP), sponsored by University of Virginia.
NCT07298941 is a Phase 2 study of Insomnia and Chronic Low Back Pain (CLBP) that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 300 participants, above the 168-participant average among 151 other Insomnia trials with a reported enrollment target (79% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07298941, a Phase 2 study of Insomnia and Chronic Low Back Pain (CLBP), is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
0-10 pain severity item from the PEG
Conditions Studied
Interventions
- BEHAVIORAL Cognitive-behavioral therapy for insomnia (CBTi)
- BEHAVIORAL CBTi + Savoring Meditation
- BEHAVIORAL CBTi + Pain Education
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-12-16 |
| Est. Completion | 2030-04-30 |
| Phase | Phase 2 |
What NCT07298941 shows while recruiting
NCT07298941 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 168-participant average among 151 other Insomnia trials with a reported enrollment target (79% higher).
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 3 interventions - of which Cognitive-behavioral therapy for insomnia (CBTi) is the first listed.
NCT07298941 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT07298941 about?
NCT07298941 is a clinical study titled "Resilience Enhancement Following Sleep Treatment". 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 behavior...
What is the current status of trial NCT07298941?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2025-12-16. Estimated completion is 2030-04-30.
What conditions does trial NCT07298941 study?
This clinical trial studies the following conditions: Insomnia, Chronic Low Back Pain (CLBP).
What interventions are being tested in trial NCT07298941?
The interventions under investigation include: Cognitive-behavioral therapy for insomnia (CBTi) (BEHAVIORAL), CBTi + Savoring Meditation (BEHAVIORAL), CBTi + Pain Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT07298941?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07298941 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07298941's enrollment target sits among peer trials
300 24th of 151 higher than 127 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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