Boosting resilience and reducing chronic low back pain by treating sleep and adding meditation or pain education

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 adaptive interventional study delivers cognitive behavioral therapy for insomnia (CBTi) to adults with chronic low back pain and comorbid insomnia and then augments that treatment with either savoring meditation or structured pain education to determine effects on pain intensity. Participants who meet chronic low back pain and insomnia criteria receive the CBTi program and are assigned to one of the augmentation strategies. The primary outcome is change in pain intensity, and secondary outcomes include insomnia severity, positive and negative affect, and overall quality of life. The trial tests whether targeting sleep plus positive affect produces greater pain reduction than sleep treatment alone.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Patrick Finan, Ph.D. — University of Virginia School of Medicine
• Study coordinator: Zayn Shahzad
• Email: finanlab@uvahealth.org
• Phone: 434-243-5906

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.