N/A
Completed N=2,333
Tailored Non-Pharmacotherapy Services for Chronic Pain
Source: ClinicalTrials.gov NCT04523714 ↗Enrolled (actual)
2,333
Serious AEs
7.9%
Results posted
Jan 2026
Primary outcomePrimary: Minimal Clinically Important Difference (MCID) in Pain Severity at 3 Months (Yes / No) — 26.6; 32.0; 20.8 Adjusted percentage of participants — p=<0.001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimal Clinically Important Difference (MCID) in Pain Severity at 3 Months (Yes / No) |
26.6; 32.0; 20.8 | <0.001 sig |
| SECONDARY MCID in Pain Severity at 6 Months (Yes / No) |
32.9; 37.1; 22.9 | <0.001 sig |
| SECONDARY MCID in Pain Severity at 12 Months (Yes / No) |
35.9; 38.3; 27.1 | <0.001 sig |
| SECONDARY Pain Severity Score |
-1.2; -1.2; -0.8; -1.3; -1.4; -0.9 | <0.05 sig |
| SECONDARY Pain Intensity Score |
-0.9; -0.9; -0.6; -1.0; -1.1; -0.7 | <0.05 sig |
| SECONDARY Pain-related Interference Score |
-1.3; -1.4; -0.8; -1.5; -1.6; -1.0 | <0.05 sig |
| SECONDARY Social Role Functioning |
1.5; 2.2; 0.7; 2.2; 2.5; 1.0 | <0.05 sig |
| SECONDARY Physical Functioning |
1.4; 1.7; 1.0; 2.0; 1.8; 1.4 | <0.05 sig |
| SECONDARY Patient Global Impression of Change (PGIC) - Pain |
2.2; 2.0; 2.9; 2.2; 2.1; 2.8 | <0.05 sig |
| SECONDARY Patient Global Impression of Change (PGIC) - General |
2.0; 1.6; 2.7; 2.1; 1.8; 2.5 | <0.05 sig |
Eligibility Criteria
INCLUSION CRITERIA
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
- 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)
EXCLUSION CRITERIA (patient-reported):
- 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
Data sourced from ClinicalTrials.gov (NCT04523714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.