Recruiting
Phase 2

CBTi, Savoring Meditation, Pain Education

Sponsor:

University of Virginia

Code:

NCT07298941

Conditions

Chronic Low Back Pain (CLBP)

Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive-behavioral therapy for insomnia (CBTi)

CBTi + Savoring Meditation

CBTi + Pain Education

Study Details

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.

Conditions

Chronic Low Back Pain (CLBP)

Insomnia

Study ID

NCT07298941

Start date

Dec 16, 2025

Status verified date

Dec, 2025

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Oct 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Cognitive-Behavioral Therapy for Insomnia

Open Label CBTi

experimental: Cognitive-Behavioral Therapy for Insomnia plus Savoring Meditation

Open label CBTi followed by random allocation to Savoring Meditation

active comparator: Cognitive-Behavioral Therapy for Insomnia plus Pain Education

Open label CBTi followed by random allocation to Pain Education

Interventions

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.

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.

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.

Primary outcome measure

  • Pain Severity [ Time Frame: Baseline to post-intervention (11 weeks) ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Principal Investigator:

Patrick Finan, Ph.D.

More Information

Sponsor

University of Virginia

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

  • chronic low back pain
  • insomnia
  • cognitive-behavioral therapy for insomnia
  • meditation
  • savoring
  • pain
  • internet intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-12-23.