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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empowered Relief | Experimental | 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. |
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| Living Better with Chronic Pain | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Pain Interference | 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. | Baseline, then weekly post-treatment (Weeks 1-8) |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Pain Intensity | 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. | Baseline, then weekly post-treatment (Weeks 1-8) |
| PROMIS Abdominal Pain |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Location Assessment | 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. | Baseline, then weekly post-treatment (Weeks 1-8) |
| PROMIS Sleep Disturbance |
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:
Able to understand and complete questionnaires independently in English
Access to an internet-enabled device for online surveys and intervention access.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoe Krut, MSHS | Contact | 310-423-0699 | Zoe.Krut@cshs.org | |
| Samuel Eberlein, MSHS | Contact | 310-423-6721 | Samuel.Eberlein@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher V Almario, MD, MSHPM | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| 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. |
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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. |
| Baseline, then weekly post-treatment (Weeks 1-8) |
| Pain Catastrophizing Scale | 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. | Baseline, then at Weeks 4 and 8 post-treatment |
| Pain Self-Efficacy | 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. | Baseline, then at Weeks 4 and 8 post-treatment |
| Inflammatory Bowel Disease Disability Index | 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. | Baseline, then at Weeks 4 and 8 post-treatment |
| IBD Control Questionnaire | 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. | 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. |
| Baseline, then at Weeks 4 and 8 post-treatment |
| PROMIS Anxiety | 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. | Baseline, then at Weeks 4 and 8 post-treatment |
| PROMIS Depression | 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. | Baseline, then at Weeks 4 and 8 post-treatment |
| Treatment Appraisal and Satisfaction | 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. | Day 1 post-treatment |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |