Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Location contact
Christopher V Almario, MD, MSHPM
PRINCIPAL_INVESTIGATOR
Zoe Krut, MSHS
CONTACT
NCT Number: NCT07671313
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90048, United States
Christopher V Almario, MD, MSHPM
PRINCIPAL_INVESTIGATOR
Zoe Krut, MSHS
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Samuel Eberlein, MSHS
CONTACT
Zoe Krut, MSHS
CONTACT
Cedars-Sinai Medical Center
Other
Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease
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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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