Resilience Enhancement Following Sleep Treatment

Phase 2RecruitingNCT07298941

University of Virginia300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Chronic Low Back Pain (CLBP)Insomnia

Interventions

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 MeditationBEHAVIORAL

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 EducationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain Severity

0-10 pain severity item from the PEG

Time frame: Baseline to post-intervention (11 weeks)

Secondary Outcomes

Pain Severity

0-10 pain severity item from the PEG

Time frame: Baseline to 6 months follow-up

Pain Severity

0-10 pain severity item from the PEG

Time frame: Baseline to 12 month follow-up

Pain Interference

Pain interference items from the PEG

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

Disability

Oswestry Disability Index

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

Insomnia Severity

Insomnia Severity Index

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

Resilience Enhancement Following Sleep Treatment

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts