Actively Recruiting
Resilience Enhancement Following Sleep Treatment
Led by University of Virginia · Updated on 2025-12-23
300
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Resilience Enhancement Following Sleep Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ongoing low back pain for at least 3 months with pain on at least half the days in the past 6 months
- Average pain intensity of 4 or higher over the past 7 days on a 0-10 scale
- Sleep-onset, maintenance, or late insomnia symptoms lasting 6 months or more causing significant distress or impairment
You will not qualify if you...
- Currently receiving behavioral treatment for insomnia
- Currently practicing meditation regularly
- Unstable medication use for sleep, pain, or other conditions within past 3 months
- Irregular sleep schedules due to shift work (bedtimes outside 8:00 p.m. to 2:00 a.m. or wake times outside 4:00 a.m. to 10:00 a.m.)
- Mental health conditions interfering with the study or untreated sleep disorders
- No regular internet access
- Cannot read or speak English
- Severe cognitive impairment
- Currently pregnant
- Unable or unwilling to follow study protocols or deemed unsafe by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
Z
Zayn Shahzad
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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