Resilience Enhancement Following Sleep Treatment

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07298941
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive-behavioral therapy for insomnia (CBTi) — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 16, 2025
Status verified
Dec 2025
Primary completion
Oct 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Patrick Finan, Ph.D.
[email protected]
4349822281
Patrick Finan, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
University of Virginia· Charlottesville, VA

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