Social Learning and Cognitive Behavioral Therapy for Irritable Bowel Syndrome

(REACH Trial)

Overseen By Rona L Levy, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Non-English speakers, Child chronic pain, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

460 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how parents with irritable bowel syndrome (IBS) can help their young children develop healthy habits. Parents will use either a website focused on child health and safety or one that promotes child wellness behaviors through Social Learning and Cognitive Behavioral Therapy (SLCBT). The goal is to identify which approach is more effective. This trial suits parents in the U.S. who have experienced IBS or frequent abdominal pain in the past five years and care for a child aged 4 to 7. As an unphased study, it offers a unique opportunity for parents to contribute to research that could enhance child wellness strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on online surveys and website use, so it's unlikely that medication changes are required.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cognitive-behavioral therapy (CBT), a key component of Social Learning and Cognitive Behavioral Therapy (SLCBT), is a proven and safe treatment for irritable bowel syndrome (IBS). Studies have found that CBT reduces both gastrointestinal and mental health symptoms in IBS patients by teaching stress management techniques.

Various clinical trials have thoroughly tested CBT, confirming its effectiveness without causing serious side effects. This includes online and home-based versions, which have improved IBS symptoms and enhanced patients' quality of life. The treatment is generally well-tolerated, with most individuals experiencing no major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Social Learning and Cognitive Behavioral Therapy (SLCBT) for irritable bowel syndrome (IBS) because it takes a fresh approach by integrating psychological techniques to manage symptoms. Unlike standard treatments, which often focus on dietary changes and medications to alleviate physical symptoms, SLCBT targets the brain-gut interaction, aiming to reduce stress and anxiety that can exacerbate IBS. This therapy empowers patients with coping strategies and social learning tools, potentially leading to long-lasting improvements in their quality of life. By addressing the psychological aspects of IBS, SLCBT offers a holistic way to manage this complex condition.

What evidence suggests that Social Learning and Cognitive Behavioral Therapy might be an effective treatment for IBS?

Research has shown that cognitive-behavioral therapy (CBT) is an effective method for treating irritable bowel syndrome (IBS). Studies have found that psychological treatments like CBT can effectively lessen IBS symptoms. CBT has been thoroughly tested and helps manage this condition. In this trial, participants will receive either Social Learning and Cognitive Behavioral Therapy (SLCBT) or an Attention Education Control. Researchers have studied strategies involving social learning for their role in understanding and managing IBS-related behaviors. These findings suggest that combining Social Learning and Cognitive Behavioral Therapy (SLCBT) may help parents with IBS develop healthier habits for their children. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for parents over 18 with IBS who are the main caregivers of a child aged 4-6. The parent must meet ROME criteria for IBS, have been diagnosed within the last five years, and their child should live with them at least half the time. It's not for those who can't understand English, whose children have certain gastrointestinal disorders or severe chronic diseases, or lack regular internet access.

Inclusion Criteria

Parent is primarily responsible for caring for the child on a day-to-day basis

Child must currently live at least half of the time with the parent involved in intervention

Parent and child must reside in the U.S.

Exclusion Criteria

My child needs full-time special education due to a developmental disability.

My child has a severe chronic condition like juvenile arthritis or cancer.

My child has been diagnosed with a painful stomach condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the REACH program through online surveys and website use, focusing on child health and wellness behaviors.

6 weeks

Online engagement

Follow-up

Participants are monitored for changes in somatic symptoms, parenting stress, and other outcomes post-intervention.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention Education Control
• Social Learning and Cognitive Behavioral Therapy (SLCBT)

Trial Overview

The REACH program's effectiveness is being tested to see if it helps parents with IBS teach their kids healthy habits. Participants will use one of two websites: one on child health/safety and another on promoting wellness behaviors. They're randomly assigned to either site and asked to complete online surveys.

How Is the Trial Designed?

Group I: Social Learning and Cognitive Behavioral Therapy (SLCBT) Experimental Treatment 1 Intervention

Group II: Attention Education Control Placebo Group 1 Intervention

Social Learning and Cognitive Behavioral Therapy (SLCBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy (CBT) for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Irritable Bowel Syndrome (IBS)

Approved in European Union as Cognitive Behavioural Therapy (CBT) for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Irritable Bowel Syndrome (IBS)

Approved in Canada as Cognitive Behavioral Therapy (CBT) for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Irritable Bowel Syndrome (IBS)

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

Cognitive-behavioral therapy (CBT) shows some promise in improving symptoms of irritable bowel syndrome (IBS) and reducing psychosocial distress, although the evidence is limited due to methodological issues in the studies reviewed.

Future research should focus on developing more relevant CBT protocols that incorporate patient perspectives and address social stigmas associated with IBS to enhance the effectiveness of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment of irritable bowel syndrome. Toner, BB.[2019]

Cognitive Behavioral Therapy (CBT) has been shown to be an effective treatment for patients with refractory Irritable Bowel Syndrome (IBS), supported by multiple site trials in the UK and USA.

Despite its efficacy, CBT is often only available in specialized care settings, highlighting the need for improved access and delivery methods, such as digital therapeutics, to maximize its benefits for IBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills over pills? A clinical gastroenterologist's primer in cognitive behavioral therapy for irritable bowel syndrome. Lackner, JM.[2022]

Cognitive Behavioral Therapy (CBT), both home-based (MC-CBT) and clinic-based (S-CBT), provided significant and lasting relief for IBS symptoms in a study of 436 patients, with 39% and 33% of participants maintaining treatment response at 12 months, respectively.

In contrast, IBS education alone resulted in a significantly lower maintenance of treatment response at 19%, highlighting the superior efficacy of CBT approaches for long-term symptom management in IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability and Decay of Treatment Benefit of Cognitive Behavioral Therapy for Irritable Bowel Syndrome: 12-Month Follow-Up. Lackner, JM., Jaccard, J., Radziwon, CD., et al.[2020]

Cognitive Behavioral Therapy (CBT) is suggested as a treatment option for Irritable Bowel Syndrome (IBS) by the UK Department of Health, although evidence for its efficacy is not yet conclusive.

The paper outlines the principles of CBT and how they can be specifically applied to IBS, providing guidelines for gastroenterologists to enhance their practice based on existing outcome data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy for irritable bowel syndrome. Hutton, J.[2019]

Cognitive behaviour therapy (CBT) showed positive effects in treating two patients with atopic dermatitis, leading to reductions in anxiety, depression, and feelings of stigmatization, as well as improvements in quality of life.

While self-rated severity of atopic dermatitis remained stable, CBT effectively reduced avoidance behaviors, suggesting it can be a valuable adjunct treatment to improve psychological well-being in patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How beneficial is cognitive behaviour therapy in the treatment of atopic dermatitis? A single-case study. Wittkowski, A., Richards, HL.[2018]

A study involving 175 young people aged 7-18 with anxiety disorders showed that Internet-delivered cognitive behavior therapy (iCBT) effectively reduced anxiety symptoms, bringing most children to within the normal range after treatment.

Factors such as poor couple relationship quality and older maternal age were associated with less improvement in anxiety symptoms, indicating that while iCBT is generally effective, certain family dynamics may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behavior therapy with minimal therapist support for anxious children and adolescents: predictors of response. Spence, SH., Prosser, SJ., March, S., et al.[2021]

Irritable bowel syndrome (IBS) is linked to a dysregulation of the brain-gut axis, with specific brain areas involved in processing gut signals, indicating a complex interaction between physical and psychological factors.

Persistent somatization and other psychological variables, such as health-care seeking behavior and emotional processing difficulties, significantly contribute to the persistence of IBS symptoms and can hinder effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological abnormalities in patients with irritable bowel syndrome. Porcelli, P.[2022]

A new framework for adapting social learning and cognitive-behavioral approaches to prevent depression was developed and tested.

In a survey study involving a 2-week television miniseries based on these approaches, mood levels significantly improved in a symptomatic group that watched the segments compared to a similar group that did not, indicating the potential effectiveness of media-based interventions in depression prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The San Francisco Mood Survey Project; preliminary work toward the prevention of depression. Muñoz, RF., Glish, M., Soo-Hoo, T., et al.[2022]

This study evaluates a 12-week cognitive behavior therapy (CBT) intervention for anger management specifically designed for individuals with learning disabilities, delivered by trained staff in day services, marking a significant step in adapting CBT for this population.

The trial aims to demonstrate that lay therapists can effectively implement a manualized CBT approach, potentially improving access to psychological therapies for people with learning disabilities and addressing their often unmet needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anger management for people with mild to moderate learning disabilities: study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff. Willner, P., Jahoda, A., Rose, J., et al.[2022]

A trial involving 112 participants with irritable bowel syndrome (IBS) is set to evaluate the effectiveness of group cognitive-behavioral therapy (GCBT) in reducing IBS severity and improving quality of life, compared to a waiting list control group.

If successful, GCBT could provide a more accessible and cost-effective treatment option for IBS patients, addressing the current limitations of individual cognitive-behavioral therapy due to therapist shortages and high costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy (GCBT) versus treatment as usual (TAU) in the treatment of irritable bowel syndrome (IBS): a study protocol for a randomized controlled trial. Kikuchi, S., Oe, Y., Sasaki, Y., et al.[2023]

A randomized controlled trial involving 436 IBS patients showed that a primarily home-based cognitive behavior therapy (MC-CBT) led to significant improvements in gastrointestinal symptoms compared to patient education, with 61% of MC-CBT patients reporting substantial improvement just 2 weeks after treatment.

MC-CBT was found to be at least as effective as standard clinic-based CBT (S-CBT) in improving IBS symptoms, and patients expressed higher satisfaction with CBT treatments compared to education, indicating that home-based therapy could be a viable option for IBS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in Gastrointestinal Symptoms After Cognitive Behavior Therapy for Refractory Irritable Bowel Syndrome. Lackner, JM., Jaccard, J., Keefer, L., et al.[2022]

Cognitive-behavioral therapy (CBT) has become the most supported psychological treatment for various psychiatric conditions, including many Axis I and selected Axis II disorders, due to its evolution over four decades based on empirical evidence.

The development of CBT has followed a scientific framework that includes systematic observations, operational definitions of cognitive and behavioral constructs, and large-scale randomized controlled trials, ensuring its efficacy and adaptability in treating mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy: empirical considerations. Rector, NA.[2013]

In a study involving 114 participants with drug-refractory IBS, those who underwent 10 weeks of group cognitive-behavioral therapy with interoceptive exposure (GCBT-IE) showed significantly greater improvements in IBS symptoms and quality of life compared to a waiting list control group.

GCBT-IE was found to be a safe treatment option, with six serious adverse events reported that were deemed unrelated to the therapy, indicating its potential as an effective intervention for individuals who do not respond to medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Cognitive-Behavioral Therapy With Interoceptive Exposure for Drug-Refractory Irritable Bowel Syndrome: A Randomized Controlled Trial. Kikuchi, S., Oe, Y., Ito, Y., et al.[2022]

Cognitive-behavioral therapy (CBT) has been shown to effectively alleviate both the physical and psychological symptoms of irritable bowel syndrome (IBS), which affects 5%-20% of the general population.

Given that many pharmacological treatments have not provided adequate relief for IBS patients, CBT is recommended as a valuable treatment option for managing this common disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for the management of irritable bowel syndrome. Tang, QL., Lin, GY., Zhang, MQ.[2022]

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