Online Pain Education for Crohn's Disease and Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empowered Relief, Living Better with Chronic Pain.
- Who it may be relevant to
- Registry conditions: Crohn's Disease, Ulcerative Colitis (UC), Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease
Overview
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.
Interventions
- 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-soothi - 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.
Primary outcome measures
- PROMIS Pain Interference [Time frame: Baseline, then weekly post-treatment (Weeks 1-8)]
Secondary outcome measures (6)
- PROMIS Pain Intensity [Time frame: Baseline, then weekly post-treatment (Weeks 1-8)]
- PROMIS Abdominal Pain [Time frame: Baseline, then weekly post-treatment (Weeks 1-8)]
- Pain Catastrophizing Scale [Time frame: Baseline, then at Weeks 4 and 8 post-treatment]
- Pain Self-Efficacy [Time frame: 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]
- IBD Control Questionnaire [Time frame: Baseline, then at Weeks 4 and 8 post-treatment]
Eligibility criteria
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:
- 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.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cedars-Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT07671313 · STUDY00005007