Chronic Low Back Pain (CLBP)Phase 2RESTNCT07298941
Resilience Enhancement Following Sleep Treatment
A Phase 2 study testing Cognitive-behavioral therapy for insomnia (CBTi), CBTi + Savoring Meditation and CBTi + Pain Education in people with Chronic Low Back Pain (CLBP) and Insomnia, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP), Insomnia
- What is being tested?
- Cognitive-behavioral therapy for insomnia (CBTi), CBTi + Savoring Meditation and CBTi + Pain Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2025to 30 Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Patrick Finan, Ph.D., 4349822281, finanlab@uvahealth.org
Patrick Finan, Ph.D.
About this study
Official title: 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.
- Conditions
- Chronic Low Back Pain (CLBP), Insomnia
- Being tested
- Cognitive-behavioral therapy for insomnia (CBTi), CBTi + Savoring Meditation, CBTi + Pain Education
- Keywords
- chronic low back pain, insomnia, cognitive-behavioral therapy for insomnia, meditation, savoring, pain, internet intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy for insomnia (CBTi)Behavioural
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 MeditationBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia | Other | Open Label CBTi Receives: Behavioral: Cognitive-behavioral therapy for insomnia (CBTi) |
| Cognitive-Behavioral Therapy for Insomnia plus Savoring Meditation | Experimental | Open label CBTi followed by random allocation to Savoring Meditation Receives: Behavioral: CBTi + Savoring Meditation |
| Cognitive-Behavioral Therapy for Insomnia plus Pain Education | Active comparator | Open label CBTi followed by random allocation to Pain Education Receives: Behavioral: CBTi + Pain Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
0-10 pain severity item from the PEG
Measured: Baseline to post-intervention (11 weeks)
Secondary outcomes (5)
Pain Severity
0-10 pain severity item from the PEG
Measured: Baseline to 6 months follow-up
Pain Severity
0-10 pain severity item from the PEG
Measured: Baseline to 12 month follow-up
Pain Interference
Pain interference items from the PEG
Measured: Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up
Disability
Oswestry Disability Index
Measured: Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up
Insomnia Severity
Insomnia Severity Index
Measured: Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start16 Dec 2025
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Adaptive Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Patrick Finan, PhD, University of Virginia
- Investigators
- Patrick Finan, Ph.D., Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298941
- Sponsor's protocol ID
- SBS-7457
- Other IDs
- R01AT013240
- Acronym
- REST
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will consider data sharing requests on a case by case basis, as dictated by institutional data sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Intervention to Improve Pain Outcomes Following Cognitive Behavioral Therapy for Insomnia in Patients With Comorbid Chronic Low Back Pain and Insomnia
- ClinicalTrials.gov ID
- NCT07298941
- Acronym / sponsor ID
- REST / SBS-7457
- Conditions
- Chronic Low Back Pain (CLBP), Insomnia
- Keywords
- chronic low back pain, insomnia, cognitive-behavioral therapy for insomnia, meditation, savoring, pain, internet intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Adaptive Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia | Other | Behavioral: Cognitive-behavioral therapy for insomnia (CBTi)Open Label CBTi |
| Cognitive-Behavioral Therapy for Insomnia plus Savoring Meditation | Experimental | Behavioral: CBTi + Savoring MeditationOpen label CBTi followed by random allocation to Savoring Meditation |
| Cognitive-Behavioral Therapy for Insomnia plus Pain Education | Active comparator | Behavioral: CBTi + Pain EducationOpen label CBTi followed by random allocation to Pain Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive-Behavioral Therapy for Insomnia |
| CBTi + Savoring MeditationAfter 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. | Behavioural | Cognitive-Behavioral Therapy for Insomnia plus Savoring Meditation |
| CBTi + Pain EducationAfter 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. | Behavioural | Cognitive-Behavioral Therapy for Insomnia plus Pain Education |
Primary outcome
Pain Severity
Time frame: Baseline to post-intervention (11 weeks)
0-10 pain severity item from the PEG
5 secondary outcomes
Pain Severity
Time frame: Baseline to 6 months follow-up
Pain Severity
Time frame: Baseline to 12 month follow-up
Pain Interference
Time frame: Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up
Disability
Time frame: Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up
Insomnia Severity
Time frame: Baseline to Post-Intervention (11 weeks), 6 month follow-up, 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided. We will consider data sharing requests on a case by case basis, as dictated by institutional data sharing agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Finan, Ph.D. principal investigator
University of Virginia School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive-behavioral therapy for insomnia (CBTi), CBTi + Savoring Meditation and CBTi + Pain Education in people with Chronic Low Back Pain (CLBP) and Insomnia, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zayn Shahzad (434-243-5906, finanlab@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: Baseline to post-intervention (11 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.