Crohn's DiseaseNCT07671313
Online Pain Education for Crohn's Disease and Ulcerative Colitis
A study testing Empowered Relief and Living Better with Chronic Pain in people with Crohn's Disease and Ulcerative Colitis (UC), run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis (UC), Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
- What is being tested?
- Empowered Relief and Living Better with Chronic Pain
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Taken any oral steroid medications for IBD or any other condition in the past 2 months (including prednisone, prednisolone, and methylprednisolone [Medrol])
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Zoe Krut, MSHS, 310-423-0699, Zoe.Krut@cshs.org
Christopher V Almario, MD, MSHPM
About this study
Official title: Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease
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 up to 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis (UC), Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
- Being tested
- Empowered Relief, Living Better with Chronic Pain
- Keywords
- Pain Education, Chronic pain
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
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 PainBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Empowered Relief |
| Living Better with Chronic Pain | Active comparator | Living Better with Chronic Pain provides education on: (i) chronic pain mechanisms, (ii) nutrition and weight management, (iii) physical activity, (iv) working with healthcare providers, (v) informed treatment decisions, and (vi) medication safety. Participants randomized to the Living Better with Chronic Pain arm will be sent a link to access the ~1-hour online recording. Completion of the entire Living Better with Chronic Pain video will be monitored and confirmed by study staff. Receives: Behavioral: Living Better with Chronic Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, then weekly post-treatment (Weeks 1-8)
Secondary outcomes (6)
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.
Measured: Baseline, then weekly post-treatment (Weeks 1-8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, then at Weeks 4 and 8 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Almario, Cedars-Sinai Medical Center
- Investigators
- Christopher V Almario, MD, MSHPM, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671313
- Sponsor's protocol ID
- STUDY00005007
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07671313
- Acronym / sponsor ID
- STUDY00005007
- Conditions
- Crohn's Disease, Ulcerative Colitis (UC), Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
- Keywords
- Pain Education, Chronic pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 up to 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empowered Relief | Experimental | Behavioral: Empowered ReliefParticipants 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. |
| Living Better with Chronic Pain | Active comparator | Behavioral: Living Better with Chronic PainLiving Better with Chronic Pain provides education on: (i) chronic pain mechanisms, (ii) nutrition and weight management, (iii) physical activity, (iv) working with healthcare providers, (v) informed treatment decisions, and (vi) medication safety. Participants randomized to the Living Better with Chronic Pain arm will be sent a link to access the ~1-hour online recording. Completion of the entire Living Better with Chronic Pain video will be monitored and confirmed by study staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- Taken any oral steroid medications for IBD or any other condition in the past 2 months (including prednisone, prednisolone, and methylprednisolone [Medrol])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered ReliefEmpowered 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. | Behavioural | Empowered Relief |
| Living Better with Chronic PainLiving 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. | Behavioural | Living Better with Chronic Pain |
Primary outcome
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.
6 secondary outcomes
PROMIS Pain Intensity
Time frame: Baseline, then weekly post-treatment (Weeks 1-8)
PROMIS Abdominal Pain
Time frame: Baseline, then weekly post-treatment (Weeks 1-8)
Pain Catastrophizing Scale
Time frame: Baseline, then at Weeks 4 and 8 post-treatment
Pain Self-Efficacy
Time frame: Baseline, then at Weeks 4 and 8 post-treatment
Inflammatory Bowel Disease Disability Index
Time frame: Baseline, then at Weeks 4 and 8 post-treatment
IBD Control Questionnaire
Time frame: Baseline, then at Weeks 4 and 8 post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher V Almario, MD, MSHPM principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief and Living Better with Chronic Pain in people with Crohn's Disease and Ulcerative Colitis (UC), run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Krut, MSHS (310-423-0699, Zoe.Krut@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Pain Interference (time frame: Baseline, then weekly post-treatment (Weeks 1-8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.