Online Pain Education for Crohn's Disease and Ulcerative Colitis

Browse trials for

• Crohn Disease 1,880
• Colitis, Ulcerative 1,492
• Inflammatory Bowel Diseases 1,460
• Chronic Pain 2,930

Keywords

• Pain Education
• Remote Monitoring
• Chronic pain

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 60 is close to the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Study arms

• Experimental
  Empowered Relief

  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.

  Behavioral: Empowered Relief

• Placebo comparator
  Living Better with Chronic Pain

  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.

  Behavioral: Living Better with Chronic Pain

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.

Primary outcomes

1. 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.

   Time frame: Baseline, then weekly post-treatment (Weeks 1-8)

Secondary outcomes

1. 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.

   Time frame: Baseline, then weekly post-treatment (Weeks 1-8)

2. PROMIS Abdominal Pain

   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 weekly post-treatment (Weeks 1-8)

3. 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.

   Time frame: Baseline, then at Weeks 4 and 8 post-treatment

4. 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.

   Time frame: Baseline, then at Weeks 4 and 8 post-treatment

5. 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.

   Time frame: Baseline, then at Weeks 4 and 8 post-treatment

6. 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.

   Time frame: Baseline, then at Weeks 4 and 8 post-treatment

Other outcomes

1. 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.

   Time frame: Baseline, then weekly post-treatment (Weeks 1-8)

2. PROMIS Sleep Disturbance

   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

3. PROMIS Anxiety

   Perceived anxiety as measured by the the validated 8-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

4. PROMIS Depression

   Perceived depression as measured by the the validated 8-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: Baseline, then at Weeks 4 and 8 post-treatment

5. 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.

   Time frame: Day 1 post-treatment

Individual participant data

Plan to share: No