AzTrials
AzTrials

Chronic PainRESOLVENCT04523714

Tailored Non-Pharmacotherapy Services for Chronic Pain

A study testing Online CBT-CP based program and Virtual health coach-led CBT-CP based program in people with Chronic Pain, run by Kaiser Permanente at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The RESOLVE study is a multicenter comparative effectiveness trial of two cognitive behavioral therapy-based chronic pain (CBT-CP) treatments delivered via telehealth modalities: 1) online program and 2) live, health coach-led, virtual sessions (telephone and/or video conference). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Online CBT-CP based program and Virtual health coach-led CBT-CP based program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,333 participants
Where
4 sitesUnited States
Study dates
14 Jan 2021to 31 Aug 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Electronic Health Record-based inclusion criteria:
  • Active/enrolled in one of the 4 participating integrated health care systems at the time of query and for the prior 360 days
  • Age 18 years or older (based on date of birth documented in EHR)
  • English speaking or do not need interpreter services
  • Have at least one [at Essentia] or at least two which are >60 days apart [at KP sites] outpatient pain-related health care encounter with nonmalignant musculoskeletal pain diagnoses [as determined by ICD10 codes for any of the following: back-neck-, limb/extremity-, joint-pain, arthritic disorders, fibromyalgia, headache, orofacial/temporomandibular pain, or musculoskeletal pain] within the past 360 days
  • Do not have an encounter for surgery related to common musculoskeletal pain conditions (e.g., joint replacement, spinal fusion, carpal tunnel release surgery) [as determined by CPT and/or ICD-10 codes] within the past 60 days
Show all 14Show fewer
  • Do not have two or more separate encounters with a malignant cancer diagnosis other than non-melanoma skin cancer [as determined by ICD-10 codes] within past 60 days
  • Do not have ICD-10 code(s), Current Procedural Terminology (CPT) code(s) or department/provider encounters indicating receipt of hospice or other palliative care within the past 360 days
  • Do not have ICD-10 codes indicating severe cognitive impairment precluding participation in a behavioral/ lifestyle change program
  • Note: At the KPWA site only, one additional EHR-based exclusion criterion will be applied, which is: Do not have ICD-10 codes indicating opioid use disorder (OUD). This criterion is being applied because there is another HEAL study being conducted at KPWA that focuses on treating individuals with pain and OUD specifically.]
  • Patient-reported inclusion criteria:
  • Have high-impact chronic pain (as indicated by self-report of having pain on most or every day in past 3 months and pain limiting life or work activities on most or every day in past 3 months)
  • Have persistent pain (as indicated by self-report Pain, Enjoyment of Life and General Activity (PEG) score of ≥ 12)
  • Be able to participate in either of the active interventions (i.e., have internet and phone access required for accessing treatments)

Who cannot join

  • Have received CBT for pain or pain-related psychoeducation or behavioral skills training within in the past 6 months (in-person, by phone or videoconference, or online)
  • Currently receiving or will be starting CBT for pain or pain-related psychoeducation or behavioral skills training in the next month (in-person, by phone or videoconference, or online)
  • Currently receiving or will be starting inpatient or intensive outpatient services for substance use disorder in the next month
  • Have a planned/scheduled surgery in next 12 months related to pain condition

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Kaiser Permanente Georgia, Center for Research and Evaluation

    Atlanta, Georgia, 30309

  • Essentia Institute of Rural Health

    Duluth, Minnesota, 55805

  • Kaiser Permanente Northwest Center for Health Research

    Portland, Oregon, 97227

  • Kaiser Permanente Washington Health Research Institute

    Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches

The RESOLVE study is a multicenter comparative effectiveness trial of two cognitive behavioral therapy-based chronic pain (CBT-CP) treatments delivered via telehealth modalities: 1) online program and 2) live, health coach-led, virtual sessions (telephone and/or video conference).

Read the detailed description

Specific Aims Aim #1: Determine the effectiveness of an online, CBT-based pain management program and virtual coach-led (telephonic/video) CBT-CP on achieving clinically meaningful improvements in patients' pain severity (pain intensity + pain-related interference) relative to those receiving usual care at 3 months.

1a. Examine the impact of the active interventions on secondary pain outcomes and related quality of life outcomes (social role functioning, physical functioning, and patient global impression of change); as well as exploratory outcomes, which include long-term opioid use; comorbid symptomology (depression, anxiety, and sleep disturbance); and high impact chronic pain and graded chronic pain.

1b. Conduct subgroup analyses to determine the impact of the active interventions on specific populations and explore for potential heterogeneity of treatment effects by sex; rural/medically underserved residency; multiple pain conditions; mental health mood disorders; and negative social determinants of health.

1c. Examine the role of theory-based mediators, pain catastrophizing, pain-related self-efficacy, and perceived support, on pain-severity.

Aim #2: Assess the cost and incremental cost-effectiveness of the online and virtual coach-led CBT-CP interventions compared to each other and usual care.

Aim #3: Conduct a qualitative evaluation to understand: 1) patient experiences of the interventions, including how they relate to treatment response, variability by site, and rural/medically underserved residency status; and 2) health system issues, including adaptations and contextual factors at the site and external levels, barriers and facilitators to intervention success and potential for adoption, sustainability and dissemination.

Conditions
Chronic Pain
Being tested
Online CBT-CP based program, Virtual health coach-led CBT-CP based program
Keywords
nonpharmacologic treatment, cognitive behavioral therapy, telehealth
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online CBT-CP based programBehavioural

    Self-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills

  • Virtual health coach-led CBT-CP based programBehavioural

    Live, health coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills

Study groups in NCT04523714
Study groupRoleWhat they receive
Online CBT-CP based programActive comparatorSelf-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted)
Receives: Behavioral: Online CBT-CP based program
Virtual health coach-led CBT-CP based programActive comparatorLive, health coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted)
Receives: Behavioral: Virtual health coach-led CBT-CP based program
Usual Care plus informationNo interventionReceipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimal Clinically Important Difference (MCID) in Pain Severity at 3 Months (Yes / No)

    Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. [Pain severity score assessed via modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.]

    MCID outcome is binary; reported as the adjusted percentage of participants with MCID (> or =30% improvement) in pain severity.

    Measured: Baseline to 3 months

Secondary outcomes (9)

  1. MCID in Pain Severity at 6 Months (Yes / No)

    Minimal clinically important difference (MCID) in pain severity is defined as a 30% decrease in score on modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines) (binary)

    Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. [Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.]

    MCID outcome is binary; reported as the adjusted percentage of participants with MCID (> or =30% improvement) in pain severity.

    Measured: Baseline to 6 months

  2. MCID in Pain Severity at 12 Months (Yes / No)

    Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. [Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.]

    MCID outcome is binary; reported as the adjusted percentage of participants with MCID (> or =30% improvement) in pain severity.

    Measured: Baseline to 12 months

  3. Pain Severity Score

    Modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 11 items; range 0-10 with a higher score = worse pain severity

    Measured: Baseline to 3, 6 and 12 months

  4. Pain Intensity Score

    4-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 4 items; range 0-10 with a higher score = worse pain intensity

    Measured: Baseline to 3, 6, and 12 months

  5. Pain-related Interference Score

    7-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of 7 items; range 0-10 with a higher score = worse pain-related interference

    Measured: Baseline to 3, 6 and 12 months

  6. Social Role Functioning

    PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a: Score by summing the 4 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better ability to participate in social roles and activities. Score ≤40 indicates moderate (40-30) to severe (< 30) limitations in ability to participate.

    Measured: Baseline to 3, 6 and 12 months

  7. Physical Functioning

    PROMIS Physical Function - Short Form 6b: Score by summing the 6 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better physical functioning. Score ≤40 indicates moderate (40-30) to severe (< 30) limitations in physical functioning.

    Measured: Baseline to 3, 6 and 12 months

  8. Patient Global Impression of Change (PGIC) - Pain

    One item assessing participant's perception of change in pain since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of pain

    Measured: Primary: Baseline to 3, 6 and 12 months

  9. Patient Global Impression of Change (PGIC) - General

    One item assessing participant's perception of change in overall status since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of overall status

    Measured: Baseline to 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2020
  2. Study start14 Jan 2021
  3. Primary completion30 Apr 2024
  4. Study completion31 Aug 2025

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study uses a 3-arm, parallel intervention design; both intervention arms will be compared to usual care services.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523714
Sponsor's protocol ID
192317
Acronym
RESOLVE
Status last verified
Jan 2026
First submitted
19 Aug 2020
Last updated
22 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A releasable database containing underlying Individual Participant Data (IPD) from the primary outcomes manuscript and all National Institutes of Health (NIH) HEAL (Helping to End Addiction Long-term) Initiative common data elements will be produced and made broadly available through the NIH HEAL Initiative-designated central data repository. The database will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA) and in accordance to the standards set forth in the Department of Health and Human Services Regulations for the Protection of Human Subjects. Namely, all identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any patient. The database will not contain any institutional or healthcare system identifiers.

Publications

  • DeBar LL, Mayhew M, Wellman RD, Balderson BH, Dickerson JF, Elder CR, Justice M, Keefe FJ, McMullen CK, Owen-Smith AA, Rini C, Von Korff M, Waring S, Yarava A, Shen Z, Thompson RE, Clark AE, Casper TC, Cook AJ. Telehealth and Online Cognitive Behavioral Therapy-Based Treatments for High-Impact Chronic Pain: A Randomized Clinical Trial. JAMA. 2025 Jul 23;334(7):592-605. doi: 10.1001/jama.2025.11178. Online ahead of print.

    PubMed 40699570

  • Mayhew M, Balderson BH, Cook AJ, Dickerson JF, Elder CR, Firemark AJ, Haller IV, Justice M, Keefe FJ, McMullen CK, O'Keeffe-Rosetti MC, Owen-Smith AA, Rini C, Schneider JL, Von Korff M, Wandner LD, DeBar LL. Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Trials. 2023 Mar 16;24(1):196. doi: 10.1186/s13063-023-07165-8.

    PubMed 36927459

  • Cook AJ, Wellman RD, Mayhew M, Balderson BH, Justice M, Owen-Smith AA, Keefe FJ, Rini C, Von Korff M, DeBar LL. Predictors of patient treatment adherence and moderators of response for a randomized clinical trial comparing remote cognitive behavioral therapy approaches for high-impact chronic musculoskeletal pain. Pain. 2026 Jul 1;167(7):1657-1668. doi: 10.1097/j.pain.0000000000003971. Epub 2026 Apr 15.

    PubMed 42013134

Questions about this trial

What is this clinical trial studying?

A study testing Online CBT-CP based program and Virtual health coach-led CBT-CP based program in people with Chronic Pain, run by Kaiser Permanente at 4 sites 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 14 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal Clinically Important Difference (MCID) in Pain Severity at 3 Months (Yes / No) (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523714, which also lists 3 linked publications.

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 22 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in