Resilience Enhancement Following Sleep Treatment (REST)

An Adaptive Intervention to Improve Pain Outcomes Following Cognitive Behavioral Therapy for Insomnia in Patients With Comorbid Chronic Low Back Pain and Insomnia

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Behavioral: Cognitive-behavioral therapy for insomnia (CBTi); Behavioral: CBTi + Savoring Meditation; Behavioral: CBTi + Pain Education

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zayn Shahzad; Phone Number: 434-243-5906; Email: finanlab@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Principal Investigator: Patrick Finan, Ph.D.
      • Contact: Patrick Finan, Ph.D.; Phone Number: 4349822281; Email: finanlab@uvahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cognitive-Behavioral Therapy for Insomnia; Open Label CBTi	Behavioral: 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.
Experimental: Cognitive-Behavioral Therapy for Insomnia plus Savoring Meditation; Open label CBTi followed by random allocation to Savoring Meditation	Behavioral: 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.
Active Comparator: Cognitive-Behavioral Therapy for Insomnia plus Pain Education; Open label CBTi followed by random allocation to Pain Education	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity	0-10 pain severity item from the PEG	Baseline to post-intervention (11 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity	0-10 pain severity item from the PEG	Baseline to 6 months follow-up
Pain Severity	0-10 pain severity item from the PEG	Baseline to 12 month follow-up
Pain Interference	Pain interference items from the PEG	Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up
Disability	Oswestry Disability Index	Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up
Insomnia Severity	Insomnia Severity Index	Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Patrick Finan, Ph.D., University of Virginia School Of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pain; chronic low back pain; insomnia; meditation; internet intervention; cognitive-behavioral therapy for insomnia; savoring
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Sleep Initiation and Maintenance Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: SBS-7457; R01AT013240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will consider data sharing requests on a case by case basis, as dictated by institutional data sharing agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No