Behavioral Therapy for Crohn's Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must be taking: Anti-TNF
Disqualifiers: Inactive Crohn's, Pregnancy, Severe psychiatric, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it requires participants to start a new biologic medication for Crohn's disease. It's best to discuss with the trial team or your doctor about your current medications.
What data supports the effectiveness of the treatment for Crohn's Disease?
Mindfulness-Based Cognitive Therapy (MBCT) has shown promise in improving psychological distress and quality of life in other populations, and Acceptance and Commitment Therapy (ACT) has been found to reduce stress in patients with inflammatory bowel diseases, which includes Crohn's Disease.
12345Is behavioral therapy safe for people with Crohn's Disease?
Behavioral therapies like mindfulness and acceptance and commitment therapy (ACT) have been used safely in people with inflammatory bowel diseases (IBD), including Crohn's Disease, to help reduce stress and improve mental well-being.
12345How is the IBD Coping Strategies Program treatment different from other treatments for Crohn's Disease?
The IBD Coping Strategies Program is unique because it focuses on psychological therapies like mindfulness and cognitive behavioral therapy (CBT) to help manage stress and improve quality of life, rather than relying solely on medication. This approach addresses the mental and emotional aspects of living with Crohn's Disease, which can be significant for many patients.
12346Eligibility Criteria
This trial is for people who have been living with Crohn's disease for less than 5 years and are about to begin a new biologic medication due to active disease. It aims to help them cope better emotionally and physically.Inclusion Criteria
My Crohn's disease is currently active.
Participants will need to live in one of Dr Keefer's 30+ PSYPACT licensed states
My recent colonoscopy shows significant inflammation in my intestines.
+2 more
Exclusion Criteria
Pregnant or planning to become pregnant in next 12 months
Severe psychiatric symptoms
My Crohn's disease is not active according to my last endoscopy.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a combination of biologic medication and coping strategies program over a 12-month period
52 weeks
7 sessions for coping strategies
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Long-term
Participant Groups
The study tests if combining coping strategies from the IBD Coping Strategies Program with biologic medications can improve emotional well-being and lead to clinical remission in Crohn's patients, compared to just offering support through the IBD Support Program.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Primary Intervention for Combination Therapy - IBD Coping Strategies ProgramExperimental Treatment1 Intervention
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.
Group II: Time and Attention Control Group - IBD Support Program (Standard Therapy)Placebo Group1 Intervention
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.
IBD Coping Strategies Program is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as IBD Coping Strategies Program for:
- Crohn's disease
- Ulcerative colitis
- Inflammatory bowel disease (IBD)
🇪🇺 Approved in European Union as Cognitive Behavioral Therapy (CBT) for IBD for:
- Crohn's disease
- Ulcerative colitis
- Inflammatory bowel disease (IBD)
🇨🇦 Approved in Canada as Mindfulness-Based Interventions for IBD for:
- Crohn's disease
- Ulcerative colitis
- Inflammatory bowel disease (IBD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
The Leona M. and Harry B. Helmsley Charitable TrustCollaborator
References
Acceptance and Commitment Therapy Reduces Psychological Stress in Patients With Inflammatory Bowel Diseases. [2019]Patients with Crohn's disease or ulcerative colitis have relatively high levels of stress and psychological dysfunction. Acceptance and commitment therapy (ACT) is a psychological intervention that comprises acceptance and mindfulness procedures, along with commitment and behavior change strategies, to increase psychological flexibility and reduce stress. We performed a randomized controlled trial to investigate the effect of ACT on stress in patients with inflammatory bowel diseases (IBD).
Mindfulness-Based Cognitive Therapy Experiences in Youth With Inflammatory Bowel Disease and Depression: Protocol for a Mixed Methods Qualitative Study. [2020]Mindfulness-based programs are increasingly used as a part of integrated treatment for inflammatory bowel disease (IBD). However, the majority of research has been quantitative with limited qualitative exploration of patients' experiences of mindfulness programs and no studies among adolescents and young adults with IBD. Furthermore, there has been a paucity of research exploring the role of common psychotherapy and group factors within mindfulness programs.
Effectiveness of Mindfulness-Based Cognitive Therapy in reducing psychological distress and improving sleep in patients with Inflammatory Bowel Disease: study protocol for a multicentre randomised controlled trial (MindIBD). [2023]Many patients with Inflammatory Bowel Diseases (IBD) suffer from psychological distress, fatigue and sleep disturbances, which are associated with reduced quality of life (QoL) and increased societal costs. Only limited psychosocial treatment options are available. As Mindfulness-Based Cognitive Therapy (MBCT) has demonstrated to improve psychological distress, QoL and sleep in other populations, MBCT might also be effective in patients with IBD.
The physiological and psychological effects of cognitive behavior therapy on patients with inflammatory bowel disease before COVID-19: a systematic review. [2021]Cognitive behavioral therapy (CBT) is now included in the treatment of patients with inflammatory bowel disease (IBD) in many settings. However, different clinical trials report different outcomes without consensus. This study aims to evaluate the impact of CBT on the mental state, quality of life and disease activity of patients with IBD.
A systematic review and meta-analysis of mindfulness based interventions and yoga in inflammatory bowel disease. [2020]Mindfulness interventions are increasingly used as a part of integrated treatment in inflammatory bowel disease (IBD) but there are limited data and a lack of consensus regarding effectiveness.
A Case Report of Improvement in Crohn's Disease-related Symptoms Following Participation in a Comprehensive Mind-Body Program. [2020]Stress is widely believed to play a role in the development and pathogenesis of inflammatory bowel disease (IBD), and several studies of mind-body programs have suggested benefits in this patient population. Here we describe a case report of a young man with a flare in Crohn's disease-related symptoms that improved in response to a comprehensive, multi-modal, mind-body program and the development of a novel IBD treatment center that incorporates mind-body approaches, nutrition, and other modalities to provide more holistic and patient-centered care for individuals with IBD.