Health TrialsbyHealthPanel

Resilience Enhancement Following Sleep Treatment

ConditionsChronic Low Back Pain (CLBP)Insomnia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Cognitive-Behavioral Therapy for InsomniaOther 1 intervention
Group B: Cognitive-Behavioral Therapy for Insomnia plus Savoring MeditationExperimental treatment 1 intervention
Group C: Cognitive-Behavioral Therapy for Insomnia plus Pain EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Severity

0-10 pain severity item from the PEG

Time frame
Baseline to post-intervention (11 weeks)

Secondary outcomes

1

Pain Severity

0-10 pain severity item from the PEG

Time frame
Baseline to 6 months follow-up
2

Pain Severity

0-10 pain severity item from the PEG

Time frame
Baseline to 12 month follow-up
3

Pain Interference

Pain interference items from the PEG

Time frame
Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up
4

Disability

Oswestry Disability Index

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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