NCT04523714

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,333

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

August 19, 2020

Results QC Date

May 1, 2025

Last Update Submit

January 5, 2026

Conditions

Chronic Pain

Keywords

nonpharmacologic treatmentcognitive behavioral therapytelehealth

Outcome Measures

Primary Outcomes (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.

    Baseline to 3 months

Secondary Outcomes (9)

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

    Baseline to 6 months

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

    Baseline to 12 months

  • Pain Severity Score

    Baseline to 3, 6 and 12 months

  • Pain Intensity Score

    Baseline to 3, 6, and 12 months

  • Pain-related Interference Score

    Baseline to 3, 6 and 12 months

  • +4 more secondary outcomes

Study Arms (3)

Online CBT-CP based program

ACTIVE COMPARATOR

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 (no usual care services restricted)

Behavioral: Online CBT-CP based program

Virtual health coach-led CBT-CP based program

ACTIVE COMPARATOR

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 (no usual care services restricted)

Behavioral: Virtual health coach-led CBT-CP based program

Usual Care plus information

NO INTERVENTION

Receipt 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

Interventions

Virtual health coach-led CBT-CP based programBEHAVIORAL

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

Virtual health coach-led CBT-CP based program
Online CBT-CP based programBEHAVIORAL

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

Online CBT-CP based program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kaiser Permanente Georgia, Center for Research and Evaluation

Atlanta, Georgia, 30309, United States

Location

Essentia Institute of Rural Health

Duluth, Minnesota, 55805, United States

Location

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, 97227, United States

Location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • 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.

    PMID: 40699570BACKGROUND

  • 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.

    PMID: 36927459BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Meghan Mayhew
Organization
Kaiser Permanente
meghan.h.mayhew@kpchr.org
(564) 248-6303

Study Officials

  • Lynn L DeBar, PhD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Primary and secondary outcome assessors will be masked to treatment assignment. It is not feasible for participants to be masked to treatment arm assignment due to the type of intervention. The PI and select Co-Investigators and study staff who are involved in the oversight and delivery of the interventions will also be aware of treatment assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study uses a 3-arm, parallel intervention design; both intervention arms will be compared to usual care services.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 24, 2020

Study Start

January 14, 2021

Primary Completion

April 30, 2024

Study Completion

August 31, 2025

Last Updated

January 22, 2026

Results First Posted

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
The database will be released at the time of publication of the primary manuscript, or within 12 months of last patient procedure, whichever comes first. The duration of availability will be in accordance with procedures and regulations of the NIH HEAL Initiative and the project funder (NIA).
Access Criteria
Access to the releasable database housed in the NIH-assigned repository will be in accordance with procedures and regulations of the NIH HEAL Initiative and the project funder (NIA).

Locations

US(4)