Behavioral Therapy for Crohn's Disease

Recruiting at 1 trial location

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?

This trial explores how combining coping strategies with medication can improve the lives of people with Crohn's disease (CD). It tests whether adding a program focused on stress reduction and self-management to the usual biologic medication reduces stress, builds resilience, and enhances well-being. Participants will receive either the IBD Coping Strategies Program (a behavioral therapy) or a standard therapy focused on support and education. This trial may suit someone diagnosed with CD in the last five years, experiencing active symptoms, and planning to start a new biologic medication. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment strategies for Crohn's disease.

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 prior data suggests that this behavioral therapy is safe for people with Crohn's disease?

Studies have shown that behavioral therapies like mindfulness and acceptance and commitment therapy (ACT) are safe for people with inflammatory bowel diseases (IBD). These therapies help reduce stress and improve emotional well-being. Research indicates that psychological treatments for IBD, including Crohn’s disease, are generally well-tolerated and typically don't cause side effects, as they don't involve surgery or drugs. While treatments can affect people differently, these therapies aim to build resilience and self-confidence, which has been linked to better disease management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Crohn's disease, which typically focus on medication to manage inflammation and symptoms, the IBD Coping Strategies Program takes a behavioral approach. This unique program aims to equip patients with stress reduction techniques, resilience-building exercises, and strategies for fostering self-confidence and disease acceptance. Researchers are excited about this program because these psychological and behavioral interventions can significantly improve how patients adjust to their condition and manage it day-to-day, potentially leading to better overall outcomes without relying solely on medication.

What evidence suggests that the IBD Coping Strategies Program could be effective for Crohn's disease?

Research has shown that psychological treatments can benefit people with Crohn's disease. Studies have found that techniques like cognitive behavioral therapy (CBT) and mindfulness can reduce stress and enhance quality of life. In this trial, participants may receive the IBD Coping Strategies Program, designed to lower stress and boost self-confidence, both associated with better health outcomes. Another group will participate in the IBD Support Program, which serves as a Time and Attention Control. Overall, combining psychological care with medical treatment can improve emotional well-being and help manage Crohn's disease more effectively. ^{1 2 3 6 7}

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

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]

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]

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]

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]

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]

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

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NCT06512597 | Behavioral Therapy for Crohn's Disease

The program specifically focuses on reducing stress, building resilience, fostering self-confidence and disease acceptance, all of which have been associated ...

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A variety of psychological interventions have been studied in IBD, including cognitive behavioral therapy (CBT) and gut-directed hypnotherapy, ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0022399923000892

The effectiveness of mindfulness-based interventions in ...

MBI's are effective in reducing stress and CRP and improving mindfulness and HRQoL. MBI's may therefore be a useful adjuvant therapy in wholistic IBD care.

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Behavioral Therapy 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 ...

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The IBD-CBT manual outlines 8 weeks of flexible, modular cognitive behavioral techniques, including relaxation training, deep diaphragmatic ...

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sciencedirect.com/science/article/abs/pii/S0166432823003716

Effects of cognitive behavioral therapy on mental health ...

Their results showed that psychological therapy is not effective at improving QoL in adult patients with IBD. In contrast, another study showed ...

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Effectiveness of Mindfulness-Based Cognitive Therapy in ...

This study will provide valuable insight into the clinical effect of MBCT on psychological distress, sleep quality, fatigue and QoL in IBD ...