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Completed

NCT Number: NCT05098158

Community-Engaged Options to Facilitate Opioid Reduction

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Health Association of Spokane, Spokane, Washington, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Non-pharmacological pain treatment

Other

Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.

Primary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating

    Time frame: 6 weeks

    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).

  2. PROMIS Pain Interference Rating

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Depressive Symptoms Using Patient Health Questionnaire (PHQ-8)

    Time frame: 6 weeks

    Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms)

  2. PROMIS Self-efficacy for Managing Symptoms Short Form 4a

    Time frame: 6 weeks

    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).

  3. PROMIS Self-efficacy for Managing Emotions Short Form 4a

    Time frame: 6 weeks

    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).

  4. Anxiety Using Generalized Anxiety Disorder (GAD-7)

    Time frame: 6 weeks

    7-item scale with score range 0-21 (higher score is worsened anxiety)

  5. Interpersonal Needs Questionnaire

    Time frame: 6 weeks

    9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs)

  6. Current Opioid Misuse Measure

    Time frame: 6 weeks

    17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)

  7. Spiritual Well-being Index

    Time frame: 6 weeks

    4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)

Other outcomes

  1. Percentage of Attendance in Scheduled Telehealth Sessions

    Time frame: 6 weeks

    Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled)

  2. IBM Computer Usability and Satisfaction Questionnaires

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • Rayce Rudeen Foundation
  • Spokane Regional Health District
  • University of Washington Institute for Translational Health Science (KL2)

Registry information

Official study title

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

Acronym: COMFORT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2021
Registry last updated
Oct 6, 2025

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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