Online Pain Education for Crohn's Disease and Ulcerative Colitis

June 22, 2026 updated by: Christopher Almario, Cedars-Sinai Medical Center

Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease

Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online pain educations programs among adult patients with inflammatory bowel disease (IBD) who experience chronic pain. Each online program can be accessed on the patient's personal device, and will take about 2 hours to complete. Clinical outcomes (pain intensity, pain interference, quality of life) will be assessed via online surveys at baseline and then weekly for 8-weeks post-treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Christopher V Almario, MD, MSHPM
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Physician-confirmed diagnosis of Crohn's disease or ulcerative colitis
  • Chronic pain (visceral and/or somatic) related to IBD for at least 3 months
  • NIH PROMIS Pain Interference scale T-score ≥60

  • Medically stable, defined as:

    1. No acute IBD-related hospitalization within the past 3 months; AND
    2. No planned IBD surgery or planned therapeutic escalation within the next 2 months, including initiation of a new advanced therapy, dose escalation or switch of advanced therapy, or corticosteroid taper
  • Able to understand and complete questionnaires independently in English
  • Access to an internet-enabled device for online surveys and intervention access.

Exclusion Criteria:

  • Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation
  • Current use of standing opioid medications, given the often severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia
  • Prior participation in cognitive behavioral therapy (CBT) specifically targeting chronic IBD-related pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empowered Relief
Participants randomized to the Empowered Relief arm will be scheduled to attend a 2-hour, live-online group Empowered Relief session. Empowered Relief sessions will be conducted via Zoom. Attendance of the Empowered Relief session will be monitored by study staff throughout the 2-hour session. Following the Empowered Relief session, participants in this arm will be provided with access to the 20-minute binaural audio relaxation app the that accompanies the Empowered Relief program and promotes calm through brainwave entrainment. Participants will be instructed to utilize the binaural audio app daily for the 8-weeks following the completion of the Empowered Relief session.
Behavioral: Empowered Relief
Empowered Relief is an online pain education program. Empowered Relief 'compresses' key cognitive behavioral therapy skills, mindfulness principles, and pain neuroscience education into a highly pragmatic, scalable, single 2-hour session. Taught via Zoom by certified instructors to large groups of patients, it teaches participants to identify unhelpful pain-related thoughts, manage physiological hyperarousal, and build coping skills through cognitive reframing, guided relaxation, and self-soothing techniques. Participants receive a 20-minute binaural audio relaxation app that promotes calm through brainwave entrainment.
Placebo Comparator: Living Better with Chronic Pain
Participants randomized to the Living Better with Chronic Pain arm will be sent a link to access the 2-hour, online recording. Completion of the entire Living Better with Chronic Pain video will be monitored and confirmed by study staff.
Behavioral: Living Better with Chronic Pain
Living Better with Chronic Pain is a 2-hour online health program that provides education regarding chronic pain mechanisms, nutrition and weight management, physical activity, working with healthcare providers, informed treatment decisions, and medication safety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Pain Interference
Time Frame: Baseline, then weekly post-treatment (Weeks 1-8)
Pain interference as measured by the validated 8-item PROMIS Pain Interference (PROMIS-PI) scale. It assesses self-reported consequences of pain on relevant aspects of one's life, including the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life. This instrument is universal, rather than disease-specific. The recall period for this scale is 7 days.
Baseline, then weekly post-treatment (Weeks 1-8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Pain Intensity
Time Frame: Baseline, then weekly post-treatment (Weeks 1-8)
Pain intensity as measured by the validated 1-item PROMIS Pain Intensity Numeric Rating Scale (NRS). It asks how one would rate their pain on average over the last 7 days, on a scale of 0 to 10.
Baseline, then weekly post-treatment (Weeks 1-8)
PROMIS Abdominal Pain
Time Frame: Baseline, then weekly post-treatment (Weeks 1-8)
Abdominal pain as measured by the validated 5-item PROMIS Abdominal Pain scale. PROMIS Abdominal Pain assesses the severity of belly pain over the past 7 days. This instrument is universal, rather than disease-specific.
Baseline, then weekly post-treatment (Weeks 1-8)
Pain Catastrophizing Scale
Time Frame: Baseline, then at Weeks 4 and 8 post-treatment
Pain catastrophizing as measured by the validated 13-item Pain Catastrophizing Scale (PCS). It assesses the types of thoughts and feeling that one has when in pain. This scale does not have a specified recall period, but asks for one to review various statements describing different thoughts and feelings that may be associated with pain, and respond based on when experiencing pain previously.
Baseline, then at Weeks 4 and 8 post-treatment
Pain Self-Efficacy
Time Frame: Baseline, then at Weeks 4 and 8 post-treatment
Pain self-efficacy as measured by the validated 10-item Pain Self-Efficacy Questionnaire (PSEQ). This scale does not have a specified recall period, but asks for one to rate on a scale of 0 to 6 how confident they are that they can do various things at present, despite the pain.
Baseline, then at Weeks 4 and 8 post-treatment
Inflammatory Bowel Disease Disability Index
Time Frame: Baseline, then at Weeks 4 and 8 post-treatment
The Inflammatory Bowel Disease Disability Index is a validated, disease-specific measure that assesses the impact of Crohn's disease and ulcerative colitis on daily functioning, including physical health, body functions, activities, participation, and overall disability.
Baseline, then at Weeks 4 and 8 post-treatment
IBD Control Questionnaire
Time Frame: Baseline, then at Weeks 4 and 8 post-treatment
IBD symptoms as measured by the validated 8-item and 1-question visual analog scale (VAS) IBD Control questionnaire. It assesses perceived control over symptoms, usefulness of current treatment, and impact of IBD on various domains over the past 2 weeks.
Baseline, then at Weeks 4 and 8 post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Location Assessment
Time Frame: Baseline, then weekly post-treatment (Weeks 1-8)
Pain location as measured by a 1-item Pain Location Assessment questionnaire which asks one to select from a list all of the locations on the body where they have experienced pain in the last 7 days.
Baseline, then weekly post-treatment (Weeks 1-8)
PROMIS Sleep Disturbance
Time Frame: Baseline, then at Weeks 4 and 8 post-treatment
Sleep disturbance as measured by the validated 4-item PROMIS Sleep Disturbance questionnaire. It assesses self-reported perceptions of sleep quality, sleep process, and restoration associated with sleep. The recall period for this scale is 7 days.
Baseline, then at Weeks 4 and 8 post-treatment
PROMIS Anxiety
Time Frame: Baseline, then at Weeks 4 and 8 post-treatment
Perceived anxiety as measured by the the validated 6-item PROMIS Emotional Distress - Anxiety scale. It assesses self-reported fear, anxious misery, and hyperarousal. The recall period for this scale is 7 days.
Baseline, then at Weeks 4 and 8 post-treatment
PROMIS Depression
Time Frame: Baseline, then at Weeks 4 and 8 post-treatment
Perceived depression as measured by the the validated 6-item PROMIS Emotional Distress - Depression scale. It assesses self-reported negative mood, views of self, and social cognition. The recall period for this scale is 7 days.
Baseline, then at Weeks 4 and 8 post-treatment
Treatment Appraisal and Satisfaction
Time Frame: Day 1 post-treatment
Treatment appraisal and satisfaction as measured by a 20-item Treatment Appraisal and Satisfaction Survey. It assess usability, relevance, usefulness, and how likely one is to recommend the program to others.
Day 1 post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Christopher V Almario, MD, MSHPM, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005007

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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