Resilience Enhancement Following Sleep Treatment (REST)

University of Virginia

Status and phase: Enrolling; Phase 2

Conditions: Chronic Low Back Pain (CLBP); Insomnia

Treatments: Behavioral: CBTi + Pain Education; Behavioral: Cognitive-behavioral therapy for insomnia (CBTi); Behavioral: CBTi + Savoring Meditation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07298941

SBS-7457

R01AT013240 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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300 participants in 3 patient groups

Cognitive-Behavioral Therapy for Insomnia

Other group

Description:

Open Label CBTi

Treatment:

Behavioral: Cognitive-behavioral therapy for insomnia (CBTi)

Cognitive-Behavioral Therapy for Insomnia plus Savoring Meditation

Experimental group

Description:

Open label CBTi followed by random allocation to Savoring Meditation

Treatment:

Behavioral: CBTi + Savoring Meditation

Cognitive-Behavioral Therapy for Insomnia plus Pain Education

Active Comparator group

Description:

Open label CBTi followed by random allocation to Pain Education

Treatment:

Behavioral: CBTi + Pain Education