Community-Engaged Options to Facilitate Opioid Reduction (COMFORT)

Community-Engaged Options to Maximize and Facilitate Opioid Reduction Through Treatment

This study investigates how adults prescribed opioids for chronic noncancer pain respond to invitations to try non-opioid options of massage therapy, yoga therapy, chiropractic and physical therapies. Options will be available via telehealth consultation visits using a computer or smartphone with internet connection. The investigators will measure effects on pain, pain-related symptoms, and opioid use over time using a single-group design.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Non-pharmacological pain treatment

Detailed Description

Participants will be recruited from local primary care practices and asked to complete a baseline survey. They will then meet with a registered nurse via teleconference for a complete pain assessment. At the end of the session, participants will be asked to choose two of four available modalities for telehealth consultation. Participants will be scheduled for six telehealth sessions, once per week x six weeks with three consultations per each chosen therapy. Measurements of pain, mood, sleep, medicine use will be captured at baseline, three weeks and six weeks and examined for changes over time.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99201
      • Community Health Association of Spokane
    • Spokane, Washington, United States, 99201
      • Washington State University College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• enrollment in treatment at the CHAS Perry St or partnering clinic;
• age greater than 18 years;
• ability to read, speak, and write English;
• diagnosed with a chronic, non-cancer-based painful medical condition;
• ability to provide informed consent.

Exclusion Criteria:

• pregnancy;
• diagnosis of a cancer-based painful medical condition;
• any other medical or psychiatric condition that the PI or Co-PI physician of record determine might compromise safe study participation (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm pain treatment; Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks	Other: Non-pharmacological pain treatment; Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating	Full scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Intensity Scale version 3a that measures the construct pain intensity or severity in three items for how much it hurts on average, at its worst and at its least in the past 7 days. Scale ranges from minimum "no pain" =1 to maximum "very severe" =5 pain with a possible sum of 3-15. A total sum of the 3 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome (range 40-70 after T-score conversion).	6 weeks
PROMIS Pain Interference Rating	Scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference Scale that measures the construct pain interference in 8 items for how much pain interferes with a variety of activities in the past 7 days. Scale ranges from minimum "not at all" =1 to maximum "very much" =5 pain with a possible sum of 8-40. A total sum of the 8 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current Opioid Misuse Measure	17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)	6 weeks
Spiritual Well-being Index	4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)	6 weeks
Depressive Symptoms Using Patient Health Questionnaire (PHQ-8)	Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms)	6 weeks
PROMIS Self-efficacy for Managing Symptoms Short Form 4a	Self-efficacy self-report (range 4-20 with higher score better symptom management self-efficacy). Scores converted into T scores with 50 as the average for US adults and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome (range 40-70 after T-score conversion).	6 weeks
PROMIS Self-efficacy for Managing Emotions Short Form 4a	Self-efficacy self-report (range 4-20 ). Converted to T score where 50 equals the US adults average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome for self-efficacy for managing emotions (range 40-70 after T-score conversion).	6 weeks
Anxiety Using Generalized Anxiety Disorder (GAD-7)	7-item scale with score range 0-21 (higher score is worsened anxiety)	6 weeks
Interpersonal Needs Questionnaire	9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs)	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Attendance in Scheduled Telehealth Sessions	Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled)	6 weeks
IBM Computer Usability and Satisfaction Questionnaires	The IBM Computer Usability and Satisfaction Questionnaires was adapted to measure tele-visit program usability and satisfaction with a 4-item survey to gauge participant satisfaction with the intervention using 1-7 Likert scale. A total mean satisfaction rating was generated from the combined mean 4 satisfaction items (possible mean range 1-7 where higher score means higher satisfaction) on a Likert-style scale: The Likert-style scale for each item was: 1: Strongly disagree- 7: Strongly agree where higher numbers indicate greater satisfaction.	6 weeks

Collaborators and Investigators

• Sponsor: Washington State University
• Collaborators: University of Washington Institute for Translational Health Science (KL2); Spokane Regional Health District; Rayce Rudeen Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): January 3, 2022
• Study Completion (Actual): January 3, 2022

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: chronic pain; opioid; complementary
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: 18111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No