Online Pain Education for Crohn's Disease and Ulcerative Colitis

NCT07671313 | Not Yet Recruiting

• 1 other identifier: STUDY00005007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn's Disease; Ulcerative Colitis (UC); Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)

Keywords

Pain Education; Remote Monitoring; Chronic pain

Outcome Measures

Primary Outcomes (1)

• PROMIS Pain Interference

  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 Outcomes (6)

• PROMIS Pain Intensity

  Baseline, then weekly post-treatment (Weeks 1-8)

• PROMIS Abdominal Pain

  Baseline, then weekly post-treatment (Weeks 1-8)

• Pain Catastrophizing Scale

  Baseline, then at Weeks 4 and 8 post-treatment

• Pain Self-Efficacy

  Baseline, then at Weeks 4 and 8 post-treatment

• Inflammatory Bowel Disease Disability Index

  Baseline, then at Weeks 4 and 8 post-treatment

Other Outcomes (5)

• Pain Location Assessment

  Baseline, then weekly post-treatment (Weeks 1-8)

• PROMIS Sleep Disturbance

  Baseline, then at Weeks 4 and 8 post-treatment

• PROMIS Anxiety

  Baseline, then at Weeks 4 and 8 post-treatment

Study Arms (2)

Empowered Relief

EXPERIMENTAL

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

Living Better with Chronic Pain

PLACEBO COMPARATOR

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

Interventions

Empowered Relief BEHAVIORAL

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.

Empowered Relief

Living Better with Chronic Pain BEHAVIORAL

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.

Living Better with Chronic Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• No acute IBD-related hospitalization within the past 3 months; AND
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases; Chronic Pain

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher V Almario, MD, MSHPM

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Krut, MSHS

CONTACT

310-423-0699; Zoe.Krut@cshs.org

Samuel Eberlein, MSHS

CONTACT

310-423-6721; Samuel.Eberlein@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)