Crohn's Disease, Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), Ulcerative Colitis (UC)
Conditions
Keywords
Pain Education, Remote Monitoring, Chronic pain
Brief summary
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
BEHAVIORALEmpowered 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-soothing techniques. Participants receive a 20-minute binaural audio relaxation app that promotes calm through brainwave entrainment.
BEHAVIORALLiving 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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Interference | 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
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Intensity | 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. |
| PROMIS Abdominal Pain | 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. |
| Pain Catastrophizing Scale | 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. |
| Pain Self-Efficacy | 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. |
| Inflammatory Bowel Disease Disability Index | 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. |
| IBD Control Questionnaire | 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. |
Countries
United States
Contacts
CONTACTZoe Krut, MSHS
CONTACTSamuel Eberlein, MSHS
PRINCIPAL_INVESTIGATORChristopher V Almario, MD, MSHPM
Cedars-Sinai Medical Center
Outcome results
None listed