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Resilience Enhancement Following Sleep Treatment

NCT ID: NCT07298941

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2030-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain (CLBP) Insomnia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Adaptive Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive-Behavioral Therapy for Insomnia

Open Label CBTi

Group Type OTHER

Cognitive-behavioral therapy for insomnia (CBTi)

Intervention Type 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 plus Savoring Meditation

Open label CBTi followed by random allocation to Savoring Meditation

Group Type EXPERIMENTAL

CBTi + Savoring Meditation

Intervention Type 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 Pain Education

Open label CBTi followed by random allocation to Pain Education

Group Type ACTIVE_COMPARATOR

CBTi + Pain Education

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Patrick Finan, PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Finan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia School of Medicine

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Zayn Shahzad

Role: CONTACT

Phone: 434-243-5906

Email: [email protected]

Facility Contacts

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Patrick Finan, Ph.D.

Role: primary

Other Identifiers

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R01AT013240

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SBS-7457

Identifier Type: -

Identifier Source: org_study_id