Social Learning and Cognitive Behavioral Therapy for Irritable Bowel Syndrome
(REACH Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Seattle Children's Hospital
Disqualifiers: Non-English speakers, Child chronic pain, others
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests if using specific websites can help parents with IBS teach their young children healthy habits. The goal is to reduce the risk of children developing stomach pain by improving how parents manage stress and support their kids. The study involves parents using one of two websites focused on child health or wellness.
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.
What data supports the effectiveness of this treatment for irritable bowel syndrome?
Cognitive Behavioral Therapy (CBT) has been shown to be effective for a range of mental health issues, including anxiety and depression, which can be related to irritable bowel syndrome (IBS). Additionally, CBT has been adapted successfully for other conditions, suggesting it may help improve IBS symptoms by addressing related psychological factors.
12345Is Social Learning and Cognitive Behavioral Therapy safe for humans?
Cognitive Behavioral Therapy (CBT), including its group form (GCBT), is generally considered safe for treating conditions like irritable bowel syndrome (IBS). The studies reviewed did not report any significant safety concerns related to CBT for IBS.
678910How is Social Learning and Cognitive Behavioral Therapy (SLCBT) different from other treatments for irritable bowel syndrome (IBS)?
Social Learning and Cognitive Behavioral Therapy (SLCBT) is unique because it combines cognitive-behavioral therapy (CBT) with social learning techniques to address both the psychological and social aspects of irritable bowel syndrome (IBS). Unlike traditional medical treatments that focus on physical symptoms, SLCBT targets the brain-gut connection and helps patients manage their symptoms by changing their thought patterns and behaviors.
611121314Eligibility Criteria
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
Child must currently live at least half of the time with the parent involved in intervention
My parent has been diagnosed with IBS or had unexplained stomach pain in the last 5 years.
Parent is primarily responsible for caring for the child on a day-to-day basis
+3 more
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.
+3 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Social Learning and Cognitive Behavioral Therapy (SLCBT)Experimental Treatment1 Intervention
Group II: Attention Education ControlPlacebo Group1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Seattle Children's HospitalSeattle, WA
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Who Is Running the Clinical Trial?
Seattle Children's HospitalLead Sponsor
University of WashingtonCollaborator
References
The San Francisco Mood Survey Project; preliminary work toward the prevention of depression. [2022]A framework for the adaptation of social learning, cognitive-behavioral treatment approaches to prevention of depression is described. In addition, an illustrative example is given of a survey study that measured behavior and mood before and after a 2-week television miniseries based on these approaches; 3 of 14 behaviors showed a significant change. Mood level improved significantly more for an originally symptomatic group that watched the segments when compared to a similarly symptomatic group which did not watch them. Implications of the study for future work are delineated.
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. [2022]Cognitive behaviour therapy (CBT) is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision.
How beneficial is cognitive behaviour therapy in the treatment of atopic dermatitis? A single-case study. [2018]A single-case design was used to examine the benefits of cognitive behaviour therapy (CBT) in the treatment of two patients with atopic dermatitis (AD). Improvements were indicated for both cases in global outcome measures, with reductions in anxiety, depression and stigmatization beliefs and improvements in quality of life. Self-rated AD severity remained relatively stable across treatment time. For both cases, treatment gains were particularly evident in terms of reducing avoidance behaviours. The findings were discussed in relation to the need for CBT as an adjunct treatment for patients with AD and its potential role in improving psychological functioning.
Internet-delivered cognitive behavior therapy with minimal therapist support for anxious children and adolescents: predictors of response. [2021]In general, Internet-delivered cognitive behavior therapy (iCBT) produces significant reductions in child and adolescent anxiety, but a proportion of participants continue to show clinical levels of anxiety after treatment. It is important to identify demographic, clinical, and family factors that predict who is most likely to benefit from iCBT in order to better tailor treatment to individual needs.
Acceptance and commitment therapy: empirical considerations. [2013]Cognitive-behavioral therapy (CBT), including behavior therapy, cognitive therapy, and their integration, has evolved over the past four decades to become the most empirically supported psychological treatment for a range of psychiatric conditions, spanning the preponderance of Axis I disorders, selected Axis II disorders, and a range of associated clinical-health problems. The evolution of cognitive-behavioral theory and treatment has followed a coherent scientific framework, first introduced in the cognitive-behavioral modeling and treatment of depression, to include: (a) systematic clinical observations, (b) definition and psychometric operationalization of key disorder-specific cognitive, emotional and behavioral constructs, (c) laboratory investigation of operationalized disorder-specific processes, (d) development of comprehensive CBT treatment interventions to target the processes of empirically tested disorder-specific models, (e) progression from early noncontrolled clinical outcome studies to the development of sophisticated, large-scale randomized controlled trials testing disorder-specific CBT interventions, (f) examination of disorder-specific moderators and mediators of change in CBT treatment, and (g) openness to refinements and elaborations based on empirical updates from experimental and clinical investigations.
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. [2023]Irritable bowel syndrome (IBS) is a common disease that affects the quality of life (QOL) and social functioning of sufferers. Visceral anxiety is currently considered a key factor in the onset and exacerbation of IBS, and cognitive-behavioural therapy (CBT) targeting visceral anxiety is thought to be effective. However, access to CBT is limited due to the lack of trained therapists, the substantial time required for therapy and the associated costs. Group CBT (GCBT) may solve some of these problems. We have therefore planned this trial to examine the efficacy of GCBT for IBS.
Group Cognitive-Behavioral Therapy With Interoceptive Exposure for Drug-Refractory Irritable Bowel Syndrome: A Randomized Controlled Trial. [2022]Few people can access psychotherapy for irritable bowel syndrome (IBS). Group cognitive-behavioral therapy (GCBT) may be efficient, but the evidence for its efficacy is weak and limited. We aimed to assess the efficacy and safety of GCBT with interoceptive exposure (GCBT-IE), a novel form of GCBT for drug-refractory IBS.
Cognitive behaviour therapy for irritable bowel syndrome. [2019]The UK Department of Health states that there is suggestive, although not conclusive, evidence for the efficacy of cognitive behavioural therapy (CBT) in irritable bowel syndrome (IBS) and that CBT should be considered as a treatment option for the syndrome. This paper provides a general introduction to CBT, the principles which underlie it and how they can be applied to IBS. The components of CBT for IBS are described in some detail. Guidelines for gastroenterologists are provided on how these principles can be used to inform their practice and the existing outcome data are reviewed.
Improvement in Gastrointestinal Symptoms After Cognitive Behavior Therapy for Refractory Irritable Bowel Syndrome. [2022]There is an urgent need for safe treatments for irritable bowel syndrome (IBS) that relieve treatment-refractory symptoms and their societal and economic burden. Cognitive behavior therapy (CBT) is an effective treatment that has not been broadly adopted into routine clinical practice. We performed a randomized controlled trial to assess clinical responses to home-based CBT compared with clinic-based CBT and patient education.
Durability and Decay of Treatment Benefit of Cognitive Behavioral Therapy for Irritable Bowel Syndrome: 12-Month Follow-Up. [2020]There is a need for safe and effective IBS treatments that provide immediate and sustained improvement of IBS symptoms, particularly among more severe patients. The aim was to assess long-term clinical response of cognitive behavioral therapy (CBT) with reference to IBS education.
Cognitive-behavioral treatment of irritable bowel syndrome. [2019]There is increasing evidence that supports the view that irritable bowel disorder (IBS) is a disorder of brain-gut function. Cognitive-behavioral therapy (CBT) has received increased attention in light of this recent shift in the conceptualization of IBS. This review has two main aims. The first is to provide a critical review of controlled trials on CBT for IBS. The second is to discuss ways of further developing CBT interventions that are more clinically relevant and meaningful to health care providers and individuals with a diagnosis of IBS. A theme from a CBT intervention will be presented to illustrate how CBT interventions can be incorporated within a larger social context. A review of CBT for IBS lends some limited support for improvement in some IBS symptoms and associated psychosocial distress. This conclusion needs to be expressed with some caution, however, in light of many methodological shortcomings including small sample sizes, inadequate control conditions and failure to identify primary versus secondary outcome measures. In addition, future studies will need to further develop more relevant CBT protocols that more fully integrate the patient's perspective and challenge social cognitions about this stigmatized disorder.
Cognitive-behavioral therapy for the management of irritable bowel syndrome. [2022]Irritable bowel syndrome (IBS) is a common disorder, reported to be found in 5%-20% of the general population. Its management accounts for up to 25% of a gastroenterologist's workload in the outpatient department, and the main symptoms are abdominal pain, bloating, and altered bowel habits. Despite a great amount of available pharmacological treatments aimed at a wide variety of gastrointestinal and brain targets, many patients have not shown adequate symptom relief. In recent years, there has been increasing evidence to suggest that psychological treatments, in particular cognitive-behavioral therapy (CBT), are effective for the management of IBS. This review discusses CBT for the management of IBS. CBT has proved to be effective in alleviating the physical and psychological symptoms of IBS and has thus been recommended as a treatment option for the syndrome.
Psychological abnormalities in patients with irritable bowel syndrome. [2022]Irritable bowel syndrome (IBS) is a group of functional bowel disorders with different pathophyiological mechanisms but some common clinical features. It can be conceptualized within the biopsychosocial model of illness as a dysregulation of brain-gut axis and its relationships with psychosocial and environmental variables. Using advanced neuro-imaging techniques, it has been found that some brain centers (anterior cingulate cortex, limbic system, locus ceruleus) are active in mediating gut signals and that visceral hyperalgesia mediates perceptual sensitivity. Using new criteria for diagnosing psychosocial components of somatic illnesses, persistent somatization has been found as one of the main psychological factors that contributes to persistence of symptoms and poor treatment outcome in patients with IBS. Other psychological variables influencing symptom reporting have been identified in the constructs of health-care seeking, abuse, somatosensory amplification, and alexithymia. From a psychological viewpoint, IBS may be conceived as an abnormal cognitive processing of emotional and visceral stimuli, a tendency to perceive somatic stimuli as evidence of symptoms of disease, and to seek repeated and often unnecessary medical care.
Skills over pills? A clinical gastroenterologist's primer in cognitive behavioral therapy for irritable bowel syndrome. [2022]Irritable bowel syndrome is a common, painful, and often disabling GI disorder for which there is no satisfactory medical or dietary treatment. The past 10 years have seen the development and validation of a number of psychological treatments of which CBT is arguably the most effective based on two recently conducted multiple site trials from two investigative teams in the UK and USA.