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NCT Number: NCT07671313

Online Pain Education for Crohn's Disease and Ulcerative Colitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location contact

Christopher V Almario, MD, MSHPM

PRINCIPAL_INVESTIGATOR

Zoe Krut, MSHS

CONTACT

[email protected]

310-423-0699

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel Eberlein, MSHS

CONTACT

[email protected]

310-423-6721

Zoe Krut, MSHS

CONTACT

[email protected]

310-423-0699

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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