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Completed

NCT Number: NCT04523714

Tailored Non-Pharmacotherapy Services for Chronic Pain

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Georgia, Center for Research and Evaluation, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online CBT-CP based program

Behavioral

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 program

Behavioral

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

Primary outcomes

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

    Time frame: Baseline to 3 months

    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.

Secondary outcomes

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

    Time frame: Baseline to 6 months

    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.

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

    Time frame: Baseline to 12 months

    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.

  3. Pain Severity Score

    Time frame: Baseline to 3, 6 and 12 months

    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

  4. Pain Intensity Score

    Time frame: Baseline to 3, 6, and 12 months

    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

  5. Pain-related Interference Score

    Time frame: Baseline to 3, 6 and 12 months

    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

  6. Social Role Functioning

    Time frame: Baseline to 3, 6 and 12 months

    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.

  7. Physical Functioning

    Time frame: Baseline to 3, 6 and 12 months

    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.

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

    Time frame: Primary: Baseline to 3, 6 and 12 months

    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

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

    Time frame: Baseline to 3, 6 and 12 months

    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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Duke University
  • Essentia Health
  • Georgia State University
  • Northwestern University

Registry information

Official study title

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

Acronym: RESOLVE

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Aug 24, 2020
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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