Crohn's DiseaseNCT06512597
Behavioral Therapy for Crohn's Disease
A study testing Primary Intervention for Combination Therapy - IBD Coping Strategies Program in people with Crohn's Disease, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Primary Intervention for Combination Therapy - IBD Coping Strategies Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2024to 30 Jul 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18-65 years old) of any sex, gender, and racial/ethnic background with an endoscopically and histologically confirmed CD diagnosis will be eligible.
- Participants must have active CD symptoms as defined by a Crohn's Disease Activity Index (CDAI) of at least 220 and
- 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 levels
- 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.
- Participants will need to live in one of Dr Keefer's 30+ PSYPACT licensed states.
Who cannot join
- Endoscopically inactive Crohn's disease at baseline.
- Unable to consent to participation.
- Pregnant or planning to become pregnant in next 12 months.
- Severe psychiatric symptoms.
- Surgical history for CD.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Laurie Keefer, PhD
- Recruiting
New York Gastroenterology Associates
New York, New York, 10128
About this study
Official title: Combination Therapy of Resilience Intervention With Biologics in Crohn's Disease (CATHARSIS Trial)
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.
- Conditions
- Crohn's Disease
- Being tested
- Primary Intervention for Combination Therapy - IBD Coping Strategies Program, Time and Attention Control - IBD Support Program
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Intervention for Combination Therapy - IBD Coping Strategies ProgramBehavioural
psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine.
Time and Attention Control - IBD Support ProgramBehavioural
psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine.
| Study group | Role | What they receive |
|---|---|---|
| Primary Intervention for Combination Therapy - IBD Coping Strategies Program | Experimental | 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. Receives: Behavioral: Primary Intervention for Combination Therapy - IBD Coping Strategies Program |
| Time and Attention Control Group - IBD Support Program (Standard Therapy) | Sham comparator | 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. Receives: Behavioral: Time and Attention Control - IBD Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The PROMIS Global Health Scale
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.
Measured: at week 24
Secondary outcomes (10)
Psychological Well-Being Scale
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.
Measured: at weeks 12, 24, 36 and 52
Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)
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.
Measured: at weeks 12, 24, 36 and 52
NIH PROMIS-29
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.
Measured: at weeks 12, 24, 36 and 52
Crohn's Disease Activity Index (CDAI)
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.
Measured: at weeks 12, 36, and 52
Patient-Reported Outcomes (PRO2)
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.
Measured: at weeks 12, 24, 36, and 52
Inflammatory Bowel Disease Questionnaire (IBDQ)
Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32 item questionnaire. Full scale from 32-224, with higher score indicating better quality of life.
Measured: at weeks 12, 24, 36, and 52
UCLA GI Symptom Severity Score
UCLA GI Symptom Severity Score rates overall severity of GI symptoms. Full scale from 0-20, with higher score indicating more intense symptoms.
Measured: at weeks 12, 24, 36, and 52
Simple Endoscopic Score for Crohn's Disease (SES-CD)
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.
Measured: at 24 weeks
C-reactive protein level
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.
Measured: up to 24 weeks
fecal calprotectin level
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.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Nov 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2028 (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 Icahn School of Medicine at Mount SinaiThe 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Laurie Keefer, Icahn School of Medicine at Mount Sinai
- Investigators
- Laurie Keefer, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiRyan Ungaro, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512597
- Sponsor's protocol ID
- STUDY-24-00338
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Resilience Intervention With Biologics in Crohn's Disease (CATHARSIS Trial)
- ClinicalTrials.gov ID
- NCT06512597
- Acronym / sponsor ID
- STUDY-24-00338
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 22 Jul 2024 (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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Intervention for Combination Therapy - IBD Coping Strategies Program | Experimental | Behavioral: Primary Intervention for Combination Therapy - IBD Coping Strategies ProgramThis 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. |
| Time and Attention Control Group - IBD Support Program (Standard Therapy) | Sham comparator | Behavioral: Time and Attention Control - IBD Support ProgramThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (18-65 years old) of any sex, gender, and racial/ethnic background with an endoscopically and histologically confirmed CD diagnosis will be eligible.
- Participants must have active CD symptoms as defined by a Crohn's Disease Activity Index (CDAI) of at least 220 and
- 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 levels
- 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.
- Participants will need to live in one of Dr Keefer's 30+ PSYPACT licensed states.
Key exclusion criteria (5 listed)
- Endoscopically inactive Crohn's disease at baseline.
- Unable to consent to participation.
- Pregnant or planning to become pregnant in next 12 months.
- Severe psychiatric symptoms.
- Surgical history for CD.
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 |
|---|---|---|
| Primary Intervention for Combination Therapy - IBD Coping Strategies Programpsychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine. | Behavioural | Primary Intervention for Combination Therapy - IBD Coping Strategies Program |
| Time and Attention Control - IBD Support Programpsychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine. | Behavioural | Time and Attention Control Group - IBD Support Program (Standard Therapy) |
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.
10 secondary outcomes
Psychological Well-Being Scale
Time frame: at weeks 12, 24, 36 and 52
Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)
Time frame: at weeks 12, 24, 36 and 52
NIH PROMIS-29
Time frame: at weeks 12, 24, 36 and 52
Crohn's Disease Activity Index (CDAI)
Time frame: at weeks 12, 36, and 52
Patient-Reported Outcomes (PRO2)
Time frame: at weeks 12, 24, 36, and 52
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: at weeks 12, 24, 36, and 52
UCLA GI Symptom Severity Score
Time frame: at weeks 12, 24, 36, and 52
Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: at 24 weeks
C-reactive protein level
Time frame: up to 24 weeks
fecal calprotectin level
Time frame: up to 24 weeks
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 12 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Crohn's Disease
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Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
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Active, not recruitingPhase 4
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
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NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
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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.
Laurie Keefer, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Ryan Ungaro, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Intervention for Combination Therapy - IBD Coping Strategies Program in people with Crohn's Disease, run by Icahn School of Medicine at Mount Sinai at 2 sites 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Laurie Keefer, PhD (212-824-7770, laurie.keefer@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The PROMIS Global Health Scale (time frame: at week 24). 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 12 Aug 2026.