Resilience Enhancement Following Sleep Treatment

NCT07298941 | Recruiting Phase 2 DMC

• 2 other identifiers: SBS-7457R01AT013240
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain Severity

  0-10 pain severity item from the PEG

  Baseline to post-intervention (11 weeks)

Secondary Outcomes (5)

• Pain Severity

  Baseline to 6 months follow-up

• Pain Severity

  Baseline to 12 month follow-up

• Pain Interference

  Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up

• Disability

  Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up

• Insomnia Severity

  Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up

Study Arms (3)

Cognitive-Behavioral Therapy for Insomnia

OTHER

Open Label CBTi

Behavioral: Cognitive-behavioral therapy for insomnia (CBTi)

Cognitive-Behavioral Therapy for Insomnia plus Savoring Meditation

EXPERIMENTAL

Open label CBTi followed by random allocation to Savoring Meditation

Behavioral: CBTi + Savoring Meditation

Cognitive-Behavioral Therapy for Insomnia plus Pain Education

ACTIVE COMPARATOR

Open label CBTi followed by random allocation to Pain Education

Behavioral: CBTi + Pain Education

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.

Cognitive-Behavioral Therapy for Insomnia

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.

Cognitive-Behavioral Therapy for Insomnia plus Savoring Meditation

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.

Cognitive-Behavioral Therapy for Insomnia plus Pain Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Virginia: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Patrick Finan, Ph.D.

  University of Virginia School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zayn Shahzad

CONTACT

434-243-5906; finanlab@uvahealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Adaptive Clinical Trial

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 23, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)