Crohn's Disease
Coping-Skills Therapy With Biologic Treatment for Active Crohn’s Disease
This randomized study is examining emotional well-being, disease activity, and remission after coping-skills therapy or a support program alongside newly started biologic treatment in adults with active Crohn’s disease diagnosed within the past five years.
Registry title: Behavioral Therapy for Crohn's Disease
2 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–65 Years
- Treatment
- Primary Intervention for Combination Therapy - IBD Coping Strategies Program or Time and Attention Control - IBD Support Program
- Design
- Randomized · Double
- Central study contact
- Laurie Keefer, PhD212-824-7770laurie.keefer@mssm.edu
- Sponsor
- Icahn School of Medicine at Mount Sinai
Research question
When adults with active Crohn’s disease begin a new biologic, does adding a structured coping-skills program, compared with a time-and-attention support program, affect emotional well-being, disease activity, or remission over 12 months?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 65 with Crohn’s disease confirmed by endoscopy and tissue examination.
- The study is looking for people whose Crohn’s disease was diagnosed less than five years ago.
- The study is looking for people with active symptoms and objective evidence of active inflammation.
- The study is looking for people starting a listed anti-TNF or anti-IL-23 biologic within the specified eight-week window.
- Participants must live in a state where the investigator is licensed through the Psychology Interjurisdictional Compact (PSYPACT).
Participation overview
What participation may involve
Participants start a specified biologic for active Crohn’s disease and are randomly assigned to one of two seven-session telemedicine behavioral programs. The study measures emotional well-being, symptoms, quality of life, inflammation, and endoscopic disease activity. What participation may involve: - Complete seven 45-minute telemedicine sessions over 12 weeks in either the coping-skills program or the support program. - Begin one of the listed anti-TNF or anti-IL-23 biologic medications shortly before or after entering the study. - Complete questionnaires about global health, psychological well-being, self-efficacy, symptoms, functioning, and quality of life at reported follow-up time points. - Have Crohn’s disease activity assessed using clinical, endoscopic, blood, and stool measures. The behavioral sessions occur over 12 weeks, and the registry describes outcomes being followed over a 12-month period, with some measures reported through week 52.
Study interventions
What participants may receive or do
- Primary Intervention for Combination Therapy - IBD Coping Strategies Program: A seven-session behavioral program delivered by telemedicine over 12 weeks. It focuses on reducing stress, building resilience and self-confidence, accepting the disease, and supporting disease self-management.
- Time and Attention Control - IBD Support Program: A seven-session comparison program delivered by telemedicine over 12 weeks. The therapist provides supportive listening, disease education, and guided self-reflection.
Study design
How the comparison works
This is a parallel-group interventional study with an estimated 170 participants. Each participant is assigned to either the coping-skills program or a time-and-attention support program while starting biologic treatment. Participants are assigned randomly to one of the two behavioral-program groups. The registry describes the study as double-masked: care providers and outcome assessors are masked. It does not state that participants or the behavioral therapists are masked. The comparison group receives seven sessions of supportive listening, disease education, and self-reflection, designed to match the intervention group’s time and attention. The registry summary calls the trial placebo-controlled, while the arm information identifies the comparison as a sham time-and-attention behavioral program rather than an inactive drug placebo.
Reported activities
Procedures and tests
- A 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire is assessed at week 24.
- Questionnaires assess psychological well-being, inflammatory bowel disease self-efficacy, physical and mental health, symptoms, and quality of life at selected weeks through week 52.
- Crohn’s disease symptom severity is measured with the Crohn’s Disease Activity Index at weeks 12, 36, and 52.
- Endoscopic inflammation is measured with the Simple Endoscopic Score for Crohn’s Disease at week 24.
- A blood test measures C-reactive protein, a marker of inflammation, through week 24.
- A stool test measures fecal calprotectin, a marker used to assess intestinal inflammation, through week 24.
- Screening must confirm Crohn’s disease by endoscopy and tissue examination and confirm the required level of active symptoms and inflammation.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be ages 18 through 65 and have Crohn’s disease confirmed by endoscopy and tissue examination.
- Active Crohn’s symptoms are required, defined by a Crohn’s Disease Activity Index score of at least 220.
- Participants must also have active inflammation shown by the specified endoscopy score, imaging, or elevated fecal calprotectin or C-reactive protein.
- Participants must plan to start one of the listed anti-TNF or anti-IL-23 biologics, either within the previous two weeks or the next six weeks.
- Participants must live in one of the investigator’s states licensed through the Psychology Interjurisdictional Compact (PSYPACT).
Possible reasons someone may not be able to join
- People whose Crohn’s disease is endoscopically inactive at baseline are excluded.
- People who cannot provide consent are excluded.
- People who are pregnant or plan to become pregnant during the next 12 months are excluded.
- People with severe psychiatric symptoms are excluded, although the registry does not define the symptoms or severity threshold.
- The registry excludes people with a surgical history for Crohn’s disease but does not specify which operations are covered.
Important unknowns
What the record does not make clear
- The registry gives assessment time points but does not provide a complete schedule of study visits or distinguish remote from in-person assessments.
- The study is randomized between two groups, but the registry does not report the assignment ratio or each participant’s probability of receiving the coping-skills program.
- Starting a listed biologic is required, but the registry does not describe biologic dosing, who chooses it, or which other Crohn’s treatments may continue.
- The registry does not state whether any current medications must be stopped or changed before enrollment.
- The registry does not explain how worsening Crohn’s disease would be treated during the study.
- An endoscopic score is an outcome at week 24, but the registry does not describe the procedure schedule, preparation, sedation, or whether an existing examination can be used.
- The registry does not state which treatment, tests, procedures, or clinical-care costs are paid by the study or billed to insurance.
- The registry does not state whether participants are compensated.
- The registry does not describe reimbursement or support for travel to any required in-person appointments.
- The behavioral sessions are delivered by telemedicine, but the registry does not say whether screening, laboratory tests, stool collection, endoscopy, and other assessments can be completed locally or remotely.
- The registry does not state whether participants can access the coping-skills program after their assigned participation ends.
Before contacting the site
Questions for the study team
- What is the complete schedule of remote and in-person sessions, tests, and assessments through week 52?
- What is the chance of assignment to each behavioral program, and what are participants told about their assignment?
- Does the week-24 endoscopic assessment require a new colonoscopy, and can it be performed by my usual gastroenterologist?
- Who selects and pays for the biologic, and which other Crohn’s medications can continue?
- What happens if Crohn’s symptoms or inflammation worsen during the study?
- How does the team define “severe psychiatric symptoms” for the exclusion criterion?
- Which prior Crohn’s operations count under the exclusion for a surgical history?
- Which costs are covered, is compensation available, and is there support for any required travel?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and how do my recent symptoms, endoscopy, imaging, and inflammation markers compare with the study’s activity requirements?
- Is one of the listed anti-TNF or anti-IL-23 biologics an appropriate treatment option for my current disease, independent of this study?
- What approved treatment alternatives should I understand before considering a study connected to starting a new biologic?
- Would any current treatment need to change, and how could medication changes or delays affect my disease control?
- How should your office and the research team coordinate biologic monitoring, laboratory tests, stool tests, endoscopy, and care for a flare?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
People living with Crohn's disease (CD) experience psychological and emotional symptoms, in addition to known chronic and disabling physical symptoms, which prevent them from living their life to the fullest (flourishing). Depression and anxiety are experienced by 30% of people living with CD and 60% of inflammatory bowel disease (IBD) patients continue to report chronic pain, stress, sleeplessness, and fatigue, even when they are "objectively" in remission. Psychological stress has been endorsed by 70% of patients with IBD as a key trigger for disease activity which is not surprising given the significance of the gut-brain-microbiome axis, the close communication between the enteric and autonomic nervous systems, and the role of the hypothalamic-pituitary axis and its neuroendocrine and immune functions in the expression of GI symptoms. Interestingly, up to 85% of patients with CD also endorse the positive impact of effective coping skills on disease course. The PI's prior work has suggested that early provision of effective coping strategies, offered at the time of diagnosis or more precisely, immediately prior to biologic medication initiation, could potentially result in faster healing and improved well-being, likely through the combination of 1) physiological mitigation of the stress response and optimization of the gut-brain-microbiome axis; and 2) promotion of effective coping and disease self-management behaviors that promote psychological flourishing despite disease. Unfortunately, to date, early effective psychosocial care has been limited by concerns over reimbursement for psychological services, access to qualified IBD mental health professionals, and the lack of a standardized methodology focused on the brain-gut stress response and how to assess, monitor, communicate and maintain tight control over both physical and emotional well-being. CATHARSIS is a rigorous, placebo-controlled, randomized controlled trial of coping strategies plus medication for 170 people living with Crohn's for less than 5 years who are about to start a new biologic medication due to active disease. Outcomes include improvements in emotional well-being as well as clinical and endoscopic remission over a 12-month period. The overall goal of the study is to demonstrate that it is essential to combine biologic therapy and psychosocial care to ensure optimal and long-term positive outcomes in CD.
Study design and administration
- Organization
- Icahn School of Medicine at Mount Sinai
- Organization class
- Other
- Organization study ID
- STUDY-24-00338
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Care Provider, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Primary Intervention for Combination Therapy - IBD Coping Strategies Program
This 7-session protocol is based on Dr. Keefer's validated Project Management for Crohn's disease treatment manual. The program specifically focuses on reducing stress, building resilience, fostering self-confidence and disease acceptance, all of which have been associated with improved adjustment to disease and better self-management outcomes in CD.
Interventions: Behavioral: Primary Intervention for Combination Therapy - IBD Coping Strategies Program
Sham Comparator
Time and Attention Control Group - IBD Support Program (Standard Therapy)
This 7-session condition will serve as a Time and Attention Control to the Coping Strategies Program. The therapist will follow Dr. Keefer's previously validated control condition manual focused on supportive listening, disease education and self-reflection.
Interventions: Behavioral: Time and Attention Control - IBD Support Program
Interventions
Behavioral
Primary Intervention for Combination Therapy - IBD Coping Strategies Program
psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine.
Behavioral
Time and Attention Control - IBD Support Program
psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine.
Eligibility
18 Years–65 Years
All
Not accepted
Inclusion criteria (5)
- Adults (18-65 years old) of any sex, gender, and racial/ethnic background with an endoscopically and histologically confirmed CD diagnosis will be eligible.Registry-derived · unreviewed
- Participants must have active CD symptoms as defined by a Crohn's Disease Activity Index (CDAI) of at least 220 andRegistry-derived · unreviewed
- Active endoscopic inflammation defined as a Simple Endoscopic Score for CD (SES-CD) \> 6 (or ≥4 for isolated ileal disease) on most recent colonoscopy OR active disease on imaging study OR elevated calprotectin/CRP levelsRegistry-derived · unreviewed
- Must be planning to start an anti-TNF (adalimumab, certolizumab, or infliximab) or anti-IL-23 (risankizumab, guselkumab, mirikizumab) within the prior 2 weeks or in the next 6 weeks.Registry-derived · unreviewed
- Participants will need to live in one of Dr Keefer's 30+ PSYPACT licensed states.Registry-derived · unreviewed
Exclusion criteria (5)
- Endoscopically inactive Crohn's disease at baseline.Registry-derived · unreviewed
- Unable to consent to participation.Registry-derived · unreviewed
- Pregnant or planning to become pregnant in next 12 months.Registry-derived · unreviewed
- Severe psychiatric symptoms.Registry-derived · unreviewed
- Surgical history for CD.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
The PROMIS Global Health Scale
Time frame: at week 24
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Secondary outcome
Psychological Well-Being Scale
Time frame: at weeks 12, 24, 36 and 52
Each item uses a 7-point scale (1=strongly agree; 7=strongly disagree) There are 6 subscales: The Autonomy subscale, The Environmental Mastery subscale, The Personal Growth subscale, The Positive Relations with Others subscale, The Purpose in Life subscale, and The Self-Acceptance subscale. Subscales scored from 3 to 21, with higher score indicating higher levels of psychological well-being. Full scale from 18 to 126, with higher score indicating higher levels of psychological well-being.
Secondary outcome
Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)
Time frame: at weeks 12, 24, 36 and 52
The IBD-SES is a 13-item questionnaire. Each item scored 1 (completely disagree) to 5 (completely agree). The IBD-SES assesses how patients manage things related to their IBD and other things in their everyday life. For each statement, they must select the number that best fits the answer for the past two weeks. Full scale from 13-65 with higher score indicating better health outcomes.
Secondary outcome
NIH PROMIS-29
Time frame: at weeks 12, 24, 36 and 52
Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) measures seven domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and the ability to participate in social roles and activities. Each domain has 4 questions ranked on a 5-point scale, and refer to the 7 previous days except physical function which has not time frame. Scoring is standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate poorer health outcomes for anxiety, depression, fatigue, ability to participate in social roles and activities, and pain interference domains. Lower scores reflect worse outcomes for physical function and sleep disturbances domains.
Secondary outcome
Crohn's Disease Activity Index (CDAI)
Time frame: at weeks 12, 36, and 52
Crohn's Disease Activity Index (CDAI) score is a measurement of the severity of the Crohn's disease symptoms. Full scale ranges from 0-600, with higher score indicating more severe disease.
Secondary outcome
Patient-Reported Outcomes (PRO2)
Time frame: at weeks 12, 24, 36, and 52
The PRO2 questionnaire assesses stool frequency and rectal bleeding, each question scored from 0-3. Full scale from 0-6, with higher score indicating poorer health outcomes.
Secondary outcome
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: at weeks 12, 24, 36, and 52
Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32 item questionnaire. Full scale from 32-224, with higher score indicating better quality of life.
Secondary outcome
UCLA GI Symptom Severity Score
Time frame: at weeks 12, 24, 36, and 52
UCLA GI Symptom Severity Score rates overall severity of GI symptoms. Full scale from 0-20, with higher score indicating more intense symptoms.
Secondary outcome
Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: at 24 weeks
Simple Endoscopic Score for Crohn's Disease (SES-CD) is used to quantify and compare inflammatory load. The Simple Endoscopic Score for Crohn Disease (SES-CD) assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates poorer health.
Secondary outcome
C-reactive protein level
Time frame: up to 24 weeks
C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation in the body. It is one of a group of proteins, called acute phase reactants that go up in response to inflammation. The levels of acute phase reactants increase in response to certain inflammatory proteins called cytokines. These proteins are produced by white blood cells during inflammation. The CRP test is a general test to check for inflammation in the body. It is not a specific test. This means it can reveal inflammation somewhere in the body, but it cannot pinpoint the exact location or reason.
Secondary outcome
fecal calprotectin level
Time frame: up to 24 weeks
Inflammatory markers measured in stool samples can be used for assessing the disease in patients who have undergone surgery. A stool test called fecal calprotectin can be of help in determining if symptoms are indicative of a flare-up of disease.
Recruiting locations in the United States
Icahn School of Medicine at Mount Sinai
RecruitingNew York, New York, 10029, United States
Laurie Keefer, PhD
New York Gastroenterology Associates
RecruitingNew York, New York, 10128, United States
Central study contacts
Registry dates
- First posted
- Jul 22, 2024
- Primary completion
- Jul 30, 2027
- Overall completion
- Jul 30, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.