Cognitive Behavioral Therapy for Irritable Bowel Syndrome
(U54_P3_CBT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of California, Los Angeles
Must not be taking: Narcotics, Opioids, Systemic steroids, others
Disqualifiers: Obesity, Major psychiatric disorders, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?Cognitive Behavioral Therapy (CBT) is the most well researched and most effective treatment for IBS targeting the brain-gut-microbiome (BGM) axis, and preliminary data show that this therapeutic effect is associated with a reduction of brainstem connectivity with other brain networks.
The increased prevalence of IBS in women, the higher rate of comorbid non-GI pain conditions, as well as the higher prevalence in female IBS of increased sensitivity to a variety of internal and external stimuli (multisensory sensitivity) suggest the presence of important sex differences in some of these BGM mechanisms.
Research performed by UCLA SCOR during previous funding has established an increased responsiveness of the CRF-Locus Coeruleus (LCC) system in female IBS subjects, suggesting that this central noradrenergic brainstem system plays an important role in IBS pathophysiology.
In addition, the study team's earlier research has begun to identify clinical, functional and structural brain mechanisms that may underlie these sex effects. Based on the preliminary data, the overall goal of this project is to use CBT as a probe to study the relationship between specific disease-related alterations of the brain, the gut microbiome, and symptomatic outcome, and identify the role of sex differences in these relationships. Investigators will study male and female IBS patients before and after CBT using the advanced neuroimaging and microbiome technologies of the overall SCOR.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that alter GI motility and gastric pH at least 72 hours before any physiologic test visit and during the baseline and treatment intervention. You will need approval from your primary care provider to stop these medications. Rescue medications like bisacodyl and loperamide are allowed during intervention periods but not during baseline or within 3 days of follow-up MRI.
What data supports the effectiveness of this treatment for irritable bowel syndrome?
Research shows that cognitive therapy, a part of cognitive behavioral therapy, significantly reduces symptoms of irritable bowel syndrome and improves psychological well-being, with benefits lasting at least three months after treatment.
12345Is Cognitive Behavioral Therapy (CBT) safe for humans?
Mindfulness-based interventions, which include forms of Cognitive Behavioral Therapy, are generally considered safe, portable, and cost-effective for managing conditions like depression and PTSD. They can be recommended as an additional strategy alongside standard care.
678910How is Cognitive Behavioral Therapy different from other treatments for irritable bowel syndrome?
Cognitive Behavioral Therapy (CBT) is unique for irritable bowel syndrome (IBS) because it focuses on changing thought patterns and behaviors that contribute to symptoms, rather than relying on medication or dietary changes. It addresses the psychological aspects of IBS, such as stress and anxiety, which can worsen symptoms, and has been shown to be effective in improving both mental health and IBS symptoms.
1112131415Eligibility Criteria
This trial is for men and women aged 18-55 with IBS, meeting ROME IV criteria. Women must be premenopausal, not pregnant or breastfeeding, and willing to use non-hormonal birth control. Participants should have no major psychiatric diagnoses or significant medical conditions that could interfere with the study.Inclusion Criteria
I am not pregnant or breastfeeding and haven't been for at least 6 months.
I am between 18 and 55 years old.
I will use non-hormonal birth control or avoid pregnancy during the study.
+7 more
Exclusion Criteria
I haven't taken antibiotics or probiotics within 3 months before joining the study.
I haven't had cancer, except for treated skin cancer, in the last 5 years.
My average abdominal pain is 3 or more on a scale of 0 to 10.
+13 more
Participant Groups
The effectiveness of Cognitive Behavioral Therapy (CBT) on IBS is being tested, focusing on sex differences in response. The study involves advanced neuroimaging and microbiome analysis before and after CBT to understand brain-gut-microbiome interactions.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Treatment ArmExperimental Treatment1 Intervention
Subjects in the "Cognitive Behavioral Treatment" Arm will undergo 8-10 weeks of remote cognitive behavioral therapy. Subjects will complete modules on their phones and will be monitored by study coordinators for support and treatment completion.
Group II: Usual Care ArmActive Control1 Intervention
Subjects in the "Usual Care" Arm will undergo 8-10 weeks of continued lifestyle. Subjects will be asked to report any new medications or lifestyle changes to study coordinators throughout the 8-10 weeks.
Cognitive Behavioral Therapy is already approved in European Union, United States, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
🇺🇸 Approved in United States as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Substance use disorders
🇨🇦 Approved in Canada as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
🇦🇺 Approved in Australia as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLALos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
A controlled comparison of cognitive therapy and self-help support groups in the treatment of irritable bowel syndrome. [2022]Thirty-four patients with irritable bowel syndrome were randomly assigned to 1 of 3 treatment conditions: individualized cognitive treatment (CT), self-help support group (SG), or symptom-monitoring waiting-list control (WL). Each of the 3 conditions lasted approximately 8 weeks. Pre- to posttreatment analyses revealed significantly greater reductions in both individual gastrointestinal (GI) symptoms and in a composite index for GI symptom change for the CT condition than for the SG or WL conditions. When compared with the SG and WL conditions, the CT condition also showed significant improvement on psychological measures of depression and anxiety. At 3-month follow-up, the results for the CT condition were maintained and revealed further numerical improvements.
Behavior therapy for irritable bowel syndrome. A case report. [2019]The behavior analysis and treatment of a patient with chronic irritable bowel syndrome are presented. The usefulness of this approach in a patient with a poor treatment prognosis is discussed.
Irritable bowel syndrome and its psychological management. [2020]Irritable Bowel Syndrome (IBS) is a chronic and disabling gastrointestinal problem that affects psychosocial functioning as well as the quality of life. This case study reports the utility of cognitive behavior therapy as a psychological intervention procedure in a chronic case of IBS. The use of psychological intervention was found to result in a reduction of anxiety; amelioration of the symptoms associated with IBS and improved functioning.
Cognitive therapy for irritable bowel syndrome. [2019]Twenty patients with irritable bowel syndrome (IBS) were randomly assigned either to intensive, individualized cognitive therapy (10 sessions over 8 weeks) or to 8 weeks of daily gastrointestinal (GI) symptom monitoring. Pre- to posttreatment evaluations showed significantly (p = .005) greater GI symptom reduction for those receiving cognitive therapy than for those in symptom monitoring. At posttreatment, 80% of the cognitive therapy group showed clinically significant improvement, whereas only 10% of the monitoring group showed this. Results held up well at a 3-month follow-up. Within the cognitive therapy group, GI symptom reductions correlated significantly with increases in positive and reductions in negative automatic thoughts.
Randomised clinical trial: symptoms of the irritable bowel syndrome are improved by a psycho-education group intervention. [2022]Evidence supports the effectiveness of cognitive behavioural approaches in improving the symptoms of the irritable bowel syndrome (IBS). Duration, cost and resistance of many patients towards a psychological therapy have limited their acceptance.
Unwanted outcomes in cognitive behavior therapy for pathological health anxiety: a systematic review and a secondary original study of two randomized controlled trials. [2023]Cognitive behavior therapy (CBT) is effective for pathological health anxiety, but little is known about unwanted outcomes.
A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). [2022]"Mindfulness-based" interventions show promise for stress reduction in general medical conditions, and initial evidence suggests that they are accepted in trauma-exposed individuals. Mindfulness-based cognitive therapy (MBCT) shows substantial efficacy for prevention of depression relapse, but it has been less studied in anxiety disorders. This study investigated the feasibility, acceptability, and clinical outcomes of an MBCT group intervention adapted for combat posttraumatic stress disorder (PTSD).
[Borderline personality disorder and non-suicidal self-injury: the role of mindfulness training in risk reduction]. [2023]Due to patients diagnosed with borderline personality disorder (BPD) can engage risky behaviors, it is necessary to develop evidence based interventions in healthcare that can help to reduce the most pressing problems. BPD-specific cognitive therapy-based mindfulness training (MBCT) can be a solution to this challange.
The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. [2018]Mindfulness-based interventions (MBIs) have been increasingly utilized in the management of mental health conditions. This first review of a two-part series evaluates the efficacy, mechanism, and safety of mindfulness meditation for mental health conditions frequently seen after return from deployment. Standard databases were searched until August 4, 2015. 52 systematic reviews and randomized clinical trials were included. The Strength of Recommendation (SOR) Taxonomy was used to assess the quality of individual studies and to rate the strength of evidence for each clinical condition. Adjunctive mindfulness-based cognitive therapy is effective for decreasing symptom severity during current depressive episode, and for reducing relapse rate in recovered patients during maintenance phase of depression management (SOR moderate [SOR B]). Adjunctive mindfulness-based stress reduction is effective for improving symptoms, mental health-related quality of life, and mindfulness in veterans with combat post-traumatic stress disorder (PTSD) (SOR B). Currently, there is no sufficient data to recommend MBIs for generalized anxiety disorder (SOR B). MBIs are safe, portable, cost-effective, and can be recommended as an adjunct to standard care or self-management strategy for major depressive disorder and PTSD. Future large, well-designed randomized clinical trials in service members and veterans can help plan for the anticipated increase in demand for behavioral health services.
Mindfulness-based cognitive therapy: theory and practice. [2018]Mindfulness-based cognitive therapy (MBCT) incorporates elements of cognitive-behavioural therapy with mindfulness-based stress reduction into an 8-session group program. Initially conceived as an intervention for relapse prevention in people with recurrent depression, it has since been applied to various psychiatric conditions. Our paper aims to briefly describe MBCT and its putative mechanisms of action, and to review the current findings about the use of MBCT in people with mood and anxiety disorders. The therapeutic stance of MBCT focuses on encouraging patients to adopt a new way of being and relating to their thoughts and feelings, while placing little emphasis on altering or challenging specific cognitions. Preliminary functional neuroimaging studies are consistent with an account of mindfulness improving emotional regulation by enhancing cortical regulation of limbic circuits and attentional control. Research findings from several randomized controlled trials suggest that MBCT is a useful intervention for relapse prevention in patients with recurrent depression, with efficacy that may be similar to maintenance antidepressants. Preliminary studies indicate MBCT also shows promise in the treatment of active depression, including treatment-resistant depression. Pilot studies have also evaluated MBCT in bipolar disorder and anxiety disorders. Patient and clinician resources for further information on mindfulness and MBCT are provided.
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.
Irritable bowel syndrome. Toward a biopsychosocial systems understanding. [2005]The symptoms of irritable bowel syndrome (IBS) are usually a subset of a broader problem that meets DSM-III criteria for depression, anxiety disorder, somatization disorder, or adjustment disorder. A biopsychosocial perspective that addresses multigenerational family patterns of anxiety, depression, and somatization of stress suggests guidelines for understanding and treating patients with IBS symptoms. Effective treatment focuses primarily on helping patients cope with emotional disorders and psychosocial stressors, and secondarily on direct symptom relief. Psychotherapy is a valuable adjunct to medical treatment. The medications most likely to yield lasting benefits are the antidepressants.
[Irritable bowel syndrome: comorbid psychiatric disorders and psychological treatment options]. [2019]Irritable bowel syndrome is a chronic functional gastrointestinal disorder with a prevalence of 7-21%. It has a negative impact on health-related quality of life and work productivity and it is associated with increased psychological distress and mental comorbidity, like major depression disorder and generalised anxiety disorder. Due to biopsychosocial factors and the brain-gut axis playing a key role in the aetiology of the disease, the use of psychological treatments has great importance in the therapy of irritable bowel syndrome. These interventions focus on central mechanisms, like visceral sensitivity, pain amplification, hypervigilance and gastrointestinal symptom-specific anxiety. They significantly reduce damaging illness-related cognitions, the use of maladaptive coping strategies, catastrophic appraisals of bodily sensations and chronic muscle tension. The utilization of these treatments is associated with clinically significant symptom improvement and positive mental health outcomes. This review study focuses on the psychiatric comorbidity of irritable bowel syndrome and the use of evidence-based psychological therapies in the treatment of the disease. Using ScienceDirect and PubMed databases, almost 60 studies have been selected. A high number of studies investigate the efficacy of cognitive behaviour therapy and hypnotherapy with meta-analyses included. There is also growing evidence on the beneficial impacts of mindfulness-based stress reduction. Future research will need to concentrate on studying the utility of mind-body therapies such as relaxation techniques in the treatment of irritable bowel syndrome with meta-analyses on the effects of mindfulness-based interventions. Orv Hetil. 2018; 159(50): 2115-21121.
Patients' Experiences of Telephone-Based and Web-Based Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Longitudinal Qualitative Study. [2021]Cognitive behavioral therapy (CBT) is recommended in guidelines for people with refractory irritable bowel syndrome (IBS). However, the availability of CBT is limited, and poor adherence has been reported in face-to-face CBT.
[The general aspects of the treatment of irritable bowel syndrome]. [2011]Irritable bowel syndrome (I.B.S.) is treated with medication, change of life style, various psychotherapies, oriental medicine, and etc., But no specific therapy is recognized useful for all the symptoms derived from I.B.S.. In fact the combination of these therapies are useful. When the therapeutic schedule is planned for individuals, we must keep it in mind that the relief from the symptoms is most important for patients.