Online Pain Education for Crohn's Disease and Ulcerative Colitis

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07671313
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

PROMIS Pain Interference [ Time Frame: Baseline, then weekly post-treatment (Weeks 1-8) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Zoe Krut, MSHS
[email protected]
310-423-0699
Christopher V Almario, MD, MSHPM (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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