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Online Pain Education for Crohn's Disease and Ulcerative Colitis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether two online pain education programs are practical to use and may help adults with Crohn’s disease or ulcerative colitis who have long-term pain. Each program takes about 2 hours on a personal device. Online surveys track pain, how pain affects daily life, and quality of life before the program and weekly for 8 weeks afterward.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A doctor has confirmed you have Crohn’s disease or ulcerative colitis.
  • You have had pain related to your bowel disease for at least 3 months.
  • Your T-score is at least 60 on the NIH PROMIS survey, which measures how pain affects daily life.
  • You have not been hospitalized for a sudden bowel disease problem in the past 3 months.
  • You have no bowel disease surgery or major treatment changes planned in the next 2 months. This includes starting, increasing, or switching an advanced treatment, or slowly reducing steroid medicine.
  • You can understand and complete surveys on your own in English.
  • You have a device with internet access to use the program and complete surveys.

Who can't join

  • You have problems with thinking or memory, or another condition, that the study team believes would prevent you from taking part.
  • You currently take opioid pain medicines on a regular schedule.
  • You have had cognitive behavioral therapy (CBT), a type of talk therapy, specifically for long-term pain related to your bowel disease.

Simplified for readability. The official criteria below are what the study team uses.

Official 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: 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 sites (1)

CA