Behavioral Therapy for Crohn's Disease

Overseen By Laurie Keefer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: Anti-TNF

Disqualifiers: Inactive Crohn's, Pregnancy, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 52 weeks

170 Participants Needed

What You Need to Know Before You Apply

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{1 2 3 4 6}

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. ^{1 2 3 4 5}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• IBD Coping Strategies Program
• IBD Support Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Primary Intervention for Combination Therapy - IBD Coping Strategies Program Experimental Treatment 1 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 Group 1 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)

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Published Research Related to This Trial

In a randomized controlled trial involving 122 patients with inflammatory bowel diseases, an 8-week Acceptance and Commitment Therapy (ACT) program led to significant reductions in stress symptoms, with a 39% reduction at 8 weeks and 45% at 20 weeks, compared to only 8% and 11% reductions in the control group.

ACT was effective in reducing perceived stress and depression levels, although it did not significantly impact anxiety or disease activity, suggesting that ACT can enhance psychological well-being in patients with IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy Reduces Psychological Stress in Patients With Inflammatory Bowel Diseases. Wynne, B., McHugh, L., Gao, W., et al.[2019]

This study aims to explore the experiences of adolescents and young adults with inflammatory bowel disease (IBD) and depression who participated in a mindfulness-based cognitive therapy (MBCT) program, focusing on the therapeutic alliance and group dynamics, which have not been previously studied in this population.

The research will provide insights into the acceptability and feasibility of MBCT for young people with IBD, potentially informing the design of a larger randomized controlled trial in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Cognitive Therapy Experiences in Youth With Inflammatory Bowel Disease and Depression: Protocol for a Mixed Methods Qualitative Study. Ewais, T., Begun, J., Kenny, M., et al.[2020]

The MindIBD study is a randomized controlled trial involving 136 patients with Inflammatory Bowel Diseases (IBD) to assess the effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in reducing psychological distress, with outcomes measured using the Hospital Anxiety and Depression Scale (HADS).

If successful, MBCT could significantly improve psychological well-being, sleep quality, and overall quality of life for IBD patients, potentially serving as a cost-effective psychosocial treatment option for chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Ter Avest, MM., van Velthoven, ASM., Speckens, AEM., et al.[2023]

Cognitive behavioral therapy (CBT) has been found to improve the quality of life and reduce depression and anxiety in patients with inflammatory bowel disease (IBD) in the short term, based on a systematic review of 11 randomized controlled trials.

However, the benefits of CBT on mental health were not sustained over time, and there is insufficient evidence to suggest that CBT affects disease activity or C-reactive protein levels in IBD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The physiological and psychological effects of cognitive behavior therapy on patients with inflammatory bowel disease before COVID-19: a systematic review. Chen, J., Chen, X., Sun, Y., et al.[2021]

Mindfulness interventions, including practices like yoga, significantly reduce stress and depression in patients with inflammatory bowel disease (IBD), with long-term effects on quality of life as shown in a meta-analysis of eight studies.

While mindfulness techniques improve psychosocial symptoms, they do not lead to significant improvements in the physical symptoms of IBD, indicating a need for more targeted research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of mindfulness based interventions and yoga in inflammatory bowel disease. Ewais, T., Begun, J., Kenny, M., et al.[2020]

A young man with Crohn's disease experienced symptom improvement after participating in a comprehensive mind-body program, suggesting that stress management may positively impact IBD symptoms.

The establishment of a novel IBD treatment center that integrates mind-body approaches and nutrition aims to offer a more holistic and patient-centered care model for individuals with inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Report of Improvement in Crohn's Disease-related Symptoms Following Participation in a Comprehensive Mind-Body Program. Dossett, ML., Korzenik, JR., Baim, M., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy Reduces Psychological Stress in Patients With Inflammatory Bowel Diseases. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Cognitive Therapy Experiences in Youth With Inflammatory Bowel Disease and Depression: Protocol for a Mixed Methods Qualitative Study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

The physiological and psychological effects of cognitive behavior therapy on patients with inflammatory bowel disease before COVID-19: a systematic review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of mindfulness based interventions and yoga in inflammatory bowel disease. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A Case Report of Improvement in Crohn's Disease-related Symptoms Following Participation in a Comprehensive Mind-Body Program. [2020]