Trial Summary
What is the purpose of this trial?This trial tests if Cognitive Behavioral Therapy (CBT) can help people with gastroparesis by reducing their pain and negative emotions. CBT involves talking through problems and practicing new ways to think and act. The study will measure changes in symptoms over time to see how effective it is.
What data supports the idea that Cognitive Behavioral Therapy for Gastroparesis is an effective treatment?The available research shows that Cognitive Behavioral Therapy (CBT) is effective for treating depression, as it helps change negative thinking and improve daily life management. While there is no specific data on CBT for Gastroparesis in the provided information, the success of CBT in treating depression suggests it could be beneficial for Gastroparesis by helping patients manage stress and anxiety related to their condition. However, more specific research would be needed to confirm its effectiveness for Gastroparesis.57101213
Is Cognitive Behavioral Therapy a promising treatment for gastroparesis?Cognitive Behavioral Therapy (CBT) is a promising treatment for gastroparesis because it focuses on improving mental health, which can help manage symptoms and improve quality of life for patients. By addressing psychological aspects, CBT may help patients cope better with the condition.368911
What safety data exists for cognitive behavioral therapies?The provided research does not directly address safety data for cognitive behavioral therapies (CBT) or its variants like DBT, MBCT, or ACT. However, these therapies are generally considered safe and are widely used for various mental health conditions. The studies mention their effectiveness and application in different contexts, such as depression, borderline personality disorder, and stress reduction, but do not specifically discuss safety concerns.124513
Do I need to stop my current medications for the trial?You must be on stable doses of any medication for 30 days before the study and agree not to change medications or dosages during the study, except for psychotropic, opioids, and/or illicit drugs, which are not allowed.
Eligibility Criteria
This trial is for adults aged 18-65 with gastroparesis, a condition causing delayed stomach emptying. Participants must have had symptoms for at least 12 weeks and not received CBT for chronic illness before. They need internet access, speak English, be on stable medication doses, and have specific BMI and gastric emptying study results. Exclusions include MRI contraindications like metal implants or claustrophobia, certain medications use, other conditions that could cause similar symptoms or inability to comply with the study.Inclusion Criteria
I've been on the same medication dose for 30 days and won't change it during the study.
I have had symptoms like nausea or feeling full quickly for at least 12 weeks.
I have never had cognitive behavioral therapy for a chronic illness.
My condition has an unknown cause.
I am between 18 and 65 years old.
My stomach empties slowly, confirmed by a test in the last 2 years.
Exclusion Criteria
I have a stomach or intestinal ulcer, diverticulitis, severe acid reflux, or an infectious stomach bug.
I am receiving nutrition through a tube or IV.
My BMI is over 32 or my weight is more than 235 lbs.
I have had surgery on my stomach to improve its function or relieve symptoms.
I am currently experiencing an acute stomach or intestinal issue.
I have epilepsy or have had seizures before.
I started psychotherapy within the last 8 weeks.
Treatment Details
The trial tests Cognitive Behavioral Therapy's (CBT) effects on gastroparesis by assessing changes in brain-gut signaling. Patients will undergo pre- and post-CBT evaluations using brain MRI scans, autonomic function tests, gastric emptying studies among others to see if CBT can improve symptoms of pain, depression, anxiety related to their condition.
1Treatment groups
Experimental Treatment
Group I: Cognitive Behavioral TherapyExperimental Treatment1 Intervention
Patients in the cognitive behavioral therapy group will be asked to undergo a 8-week CBT trial. An online videoconferencing link will be used to deliver CBT virtual sessions that will be approximately 60 minutes in length. Each session will be conducted by a clinical psychology doctoral student, supervised by a licensed psychologist. Patients will also undergo careful phenotyping pre- and post intervention with brain MRI, AFT, and NDT.
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:
Massachusetts General HospitalBoston, MA
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
References
Dialectical behavior therapy: current status, recent developments, and future directions. [2022]Dialectical behavior therapy (DBT) was developed as a treatment for parasuicidal women with borderline personality disorder and has been adapted for several other populations. This article describes standard DBT and several adaptations of it and reviews outcome studies with borderline patients in outpatient, inpatient, and crisis intervention settings, borderline patients with substance use disorders, suicidal adolescents, patients with eating disorders, inmates in correctional settings, depressed elders, and adults with attention-deficit/hyperactivity disorder. This treatment outcome review is followed by discussion of predictors of change in DBT, possible mechanisms of change, and current developments in theory, practice, and research.
The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. [2018]Cognitive-behavioral therapy (CBT) refers to a group of therapeutic techniques that can be categorized broadly as psychoeducation, cognitive restructuring, and behavioral exposure. Unlike other psychotherapeutic approaches, CBT is derived from learning laboratory experimentation rather than conjecture and theorizing. This article provides background information concerning the origins and practice of cognitive and behavioral therapies and summarizes findings from a recently completed research project at the University of Minnesota that integrates new neuroscientific findings and CBT.
The difficult patient with gastroparesis. [2007]Gastroparesis is often difficult to manage. First of all, exact criteria for making a diagnosis of gastroparesis have not been established, and merely finding delayed gastric emptying does not justify the label. Furthermore, the relationship between symptoms and gastric emptying rate is poor, and the number of therapies with proven efficacy is extremely limited. A number of technical investigations are helpful to establish the anatomy and motor function of the upper gastrointestinal tract. In most cases where gastroparesis can be presumed or established, prokinetic therapy will be tried. A number of agents are available, with variable efficacy and tolerance. Rarely, in case of debilitating refractory symptoms, experimental or invasive therapies can be tried such as injection of botulinum toxin, enteral feeding tube insertion, gastric electrical stimulation or surgery.
Dialectical behavior therapy: current indications and unique elements. [2021]Dialectical behavior therapy (DBT) is a comprehensive, evidence-based treatment for borderline personality disorder (BPD). The patient populations for which DBT has the most empirical support include parasuicidal women with borderline personality disorder (BPD), but there have been promising findings for patients with BPD and substance use disorders (SUDs), persons who meet criteria for binge-eating disorder, and depressed elderly patients. Although DBT has many similarities with other cognitive-behavioral approaches, several critical and unique elements must be in place for the treatment to constitute DBT. Some of these elements include (a) serving the five functions of treatment, (b) the biosocial theory and focusing on emotions in treatment, (c) a consistent dialectical philosophy, and (d) mindfulness and acceptance-oriented interventions.
[Cognitive therapy/cognitive behavior therapy for depression]. [2022]Cognitive behavior therapy (CBT) is a structured short-term therapy designed to change the patient's negatively distorted cognition. The effectiveness of cognitive therapy/cognitive behavior therapy has been increasingly recognized not only by professionals and academics but also by the public, and in April, 2010, this therapy started to be covered by the national health insurance in Japan. In this article, the author described the high-intensity and low-intensity CBT from the practical point of view.
The effects of comprehensive mental intervention on the recovery time of patients with postsurgical gastroparesis syndrome. [2018]To explore the effects of comprehensive mental intervention on the recovery time and symptoms of depression in patients with postsurgical gastroparesis syndrome.
Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. [2021]Cognitive behavioral therapy (CBT) is a goal-oriented treatment that guides patients to healthy thoughts and behaviors. Internet-delivered CBT with supportive coaching can be as effective as in-person psychotherapy treatment of depression.
Current and Emerging Medical Therapies for Gastroparesis. [2020]Gastroparesis likely involves various pathophysiological disorders and is increasingly prevalent as complications of surgeries, medications, and chronic diabetes. Key to diagnosis is evidence of delayed gastric emptying, generally based on standardized scintigraphy, and ruling out distal obstruction or other dysmotilities. Initial medical management includes reviewing potentially exacerbating medications and ruling out other reversible causes, achieving tighter glucose control in diabetics, and implementing dietary and lifestyle changes. While current available medications are limited, symptomatic control is aimed at improving gastric emptying, alleviating nausea and vomiting, and treating associated abdominal pain. Other potential therapies are aimed at reducing acid production, improving gastric accommodation or pyloric dysfunction, and treating bacterial overgrowth. Future studies should be aimed toward identification of subpopulations of gastroparetics who are better responders to the various medications based on differences in underlying pathophysiology and adopting standardized study end point measures that may allow for comparisons across trials. This chapter will review current treatment options, upcoming promising medications, and some of the hurdles in advancing the field forward.
Psychological controversies in gastroparesis: A systematic review. [2022]To systematically review literature addressing three key psychologically-oriented controversies associated with gastroparesis.
Basic Strategies of Cognitive Behavioral Therapy. [2018]Cognitive behavioral therapy's main strategies are active, problem-focused, and collaborative. Cognitive restructuring is a strategy in which clinicians help patients to identify, evaluate, and modify inaccurate or otherwise unhelpful thinking associated with emotional distress. Behavioral activation provides a framework for patients, particularly those who are depressed, to increase engagement in activities that provide a sense of accomplishment or pleasure. The goal of exposure is for anxious patients to experience an extinction of fear by having planned contact with feared stimuli and situations. Problem solving allows patients to systematically approach and address their life problems by using cognitive and behavioral techniques.
Surgical Management for Gastroparesis. [2019]Gastroparesis is a debilitating chronic condition of indeterminate cause. Although conservative management is the mainstay of treatment, a significant percentage of patients will need interventions. Interventions range from supportive measures, such as feeding tubes, to more radical surgeries, including endoscopic pyloromyotomy (per oral pyloromyotomy), laparoscopic pyloroplasty, laparoscopic gastric stimulator placement, and even subtotal or total gastrectomy. The authors present some current treatment algorithms focused on the treatment side of the spectrum along with outcomes data to support the various approaches.
[Cognitive Behavioral Therapy for Depression]. [2019]Cognitive behavioral therapy (CBT) is a form of psychotherapy that improves dysfunc- tional cognition, and enhances the ability to manage problems in daily life. Not only CBT tech- niques, such as behavior activation, cognitive restructuring, and problem solving, but also case formulation and therapeutic relationships are important in CBT, which are useful for psychia- trists who work at a general hospital.
Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]Mindfulness-based cognitive therapy (MBCT) is an effective group intervention for reducing rates of depression relapse. However, about one-third of graduates experience relapse within 1 year of completing the course.