NCT07298941 Resilience Enhancement Following Sleep Treatment
| NCT ID | NCT07298941 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Virginia |
| Condition | Chronic Low Back Pain (CLBP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2029-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2025-12-16 with a primary completion date of 2029-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: (1) age \>=18 years; (2) report low back pain as ongoing problem \>= 3 months and any pain on at least half of the days over the past 6 months (consistent with NIH Consensus Recommendations, other chronic pain problems can be present, but cLBP must be reported as primary); (3) average pain intensity \>= 4 over past 7 days on a 0-10 numerical rating scale; (4) sleep-onset insomnia and/or sleep maintenance insomnia and/or late insomnia (\>30 minutes of WASO or SOL or waking \>30 minutes before desired time for at least 3 nights/week) with presence of insomnia symptoms for \>= 6 months, and the sleep disturbance (or associated daytime fatigue) must cause significant distress or impairment in social, occupational, or other areas of functioning to be consistent with DSM 5 criteria (evaluated by phone interview). Exclusion Criteria: (1) currently receiving behavioral treatment for insomnia; (2) currently engaging in formal or informal meditation practice on a regular (e.g., weekly) basis; (3) unstable medication use for sleep, pain, or other indication (e.g., changed within the past 3 months); (4) irregular sleep schedules dictated by shift work (i.e., usual bedtimes outside 8:00 p.m.-2:00 a.m. or arising time outside 4:00 a.m.-10:00 a.m.); (4) mental health condition deemed to interfere with study procedures or put the participant at undue risk via semi-structured interview (e.g., screen positive for psychotic disorder) or other untreated sleep disorders (e.g., obstructive sleep apnea, restless legs syndrome) as evaluated by our semi-structured interview based on the Diagnostic Interview for Insomnia (DII); (5) do not have regular internet access; (6) cannot read and speak English (interventions only available in English); and (7) severe cognitive impairment (i.e., score =9 on the Telephone-Assessed Mental State); (8) currently pregnant; 9) unable or unwilling to comply with study protocols, or otherwise determined by the PI to be able to safely participate in the study.
Contact & Investigator
Patrick Finan, Ph.D.
PRINCIPAL INVESTIGATOR
University of Virginia School of Medicine
Frequently Asked Questions
Who can join the NCT07298941 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Low Back Pain (CLBP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07298941 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07298941 currently recruiting?
Yes, NCT07298941 is actively recruiting participants. Contact the research team at finanlab@uvahealth.org for enrollment information.
Where is the NCT07298941 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT07298941 clinical trial?
NCT07298941 is sponsored by University of Virginia. The principal investigator is Patrick Finan, Ph.D. at University of Virginia School of Medicine. The trial plans to enroll 300 participants.