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Taking people in United StatesPhase 2

Adding meditation or pain education to sleep therapy for chronic low back pain

Tests added meditation or pain education after insomnia therapy in adults with back pain.

Key facts

Who runs it
University of Virginia
Where
Charlottesville, United StatesSee the site
Trial code
Registry title
Resilience Enhancement Following Sleep Treatment
Status
Recruiting
Phase
Phase 2
People taking part
300 people, planned
Started
16 Dec 2025
Expected to end
30 Apr 2030
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cognitive-behavioral therapy for insomnia (CBTi)
  • CBTi + Savoring Meditation
  • CBTi + Pain Education
Record updated
23 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-term low back pain who also have insomnia (trouble falling or staying asleep). All get a sleep therapy program, and some then get meditation or pain education.

Age
18 years and older
Sex
All sexes
Disease stage
Low back pain for at least 3 months, with pain on at least half of the days in the past 6 months. Back pain must be the main pain problem. Average pain of at least 4 on a 0-10 scale over the past 7 days. Insomnia for at least 6 months, at least 3 nights a week, causing real distress or trouble in daily life.
Earlier treatment
People now getting behavioral (talk-based) treatment for insomnia cannot join. People who meditate regularly, for example weekly, cannot join.

Main reasons for not taking part

  • Changes to sleep, pain or other medicines within the past 3 months
  • Shift work with irregular sleep times, or other untreated sleep disorders such as sleep apnea or restless legs
  • A mental health condition that would interfere with the study or put the person at risk
  • No regular internet access, or cannot read and speak English
  • Currently pregnant, or severe memory and thinking problems

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • (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)

Who cannot take part

  • (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 in United States

  • University of VirginiaCharlottesville, United StatesContact: Patrick Finan, Ph.D.Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

Secondary objectives include evaluating improvements in insomnia severity, positive and negative affect, and overall quality of life.

The 3 groups in the trial

  • Cognitive-Behavioral Therapy for InsomniaOther group

    Open Label CBTi

    Treatment: Cognitive-behavioral therapy for insomnia (CBTi)

  • Cognitive-Behavioral Therapy for Insomnia plus Savoring MeditationTreatment being tested

    Open label CBTi followed by random allocation to Savoring Meditation

    Treatment: CBTi + Savoring Meditation

  • Cognitive-Behavioral Therapy for Insomnia plus Pain EducationExisting treatment, for comparison

    Open label CBTi followed by random allocation to Pain Education

    Treatment: CBTi + Pain Education

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Adaptive Intervention to Improve Pain Outcomes Following Cognitive Behavioral Therapy for Insomnia in Patients With Comorbid Chronic Low Back Pain and Insomnia
Plain-language title
Adding meditation or pain education to sleep therapy for chronic low back painGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
23 December 2025