29 Participants Needed

Cognitive Behavioral Therapy for Gastroparesis

HK
RK
Overseen ByRebecca Karlson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

You can continue taking your current medications if they have been stable for at least 30 days before the study and you agree not to change them during the study. However, you cannot take psychotropic drugs, opioids, or illicit drugs.

Is Cognitive Behavioral Therapy (CBT) safe for humans?

Cognitive Behavioral Therapy (CBT) and its variations, like Dialectical Behavior Therapy (DBT) and Mindfulness-Based Cognitive Therapy (MBCT), are generally considered safe for humans. They have been widely used and studied for various mental health conditions, and no significant safety concerns have been reported in the research.12345

How is Cognitive Behavioral Therapy different from other treatments for gastroparesis?

Cognitive Behavioral Therapy (CBT) is unique for gastroparesis as it focuses on changing thought patterns and behaviors to manage symptoms, unlike other treatments that primarily aim to improve gastric emptying or involve surgical interventions. This approach is novel because it addresses the psychological aspects of the condition, which are often overlooked in traditional medical or surgical treatments.678910

What data supports the effectiveness of this treatment for gastroparesis?

Cognitive Behavioral Therapy (CBT) has been shown to be effective in treating depression by helping people change negative thought patterns and behaviors. While this research focuses on depression, the techniques used in CBT, such as problem-solving and cognitive restructuring (changing unhelpful thinking), may also help people manage symptoms of gastroparesis by improving their ability to cope with the condition.12111213

Who Is on the Research Team?

Braden Kuo, MD - Mass General Advances ...

Braden Kuo, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.
Body mass index (BMI) โ‰ฅ 17.5 kg/m2
Speak, write, and understand English
See 5 more

Exclusion Criteria

Inability to comply with or complete GES test
Use of narcotic analgesics greater than three days per week
Presence of conditions that could explain the patient's symptoms
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week Cognitive Behavioral Therapy (CBT) trial with weekly sessions conducted via online videoconferencing

8 weeks
8 visits (virtual)

Post-Treatment Testing

Participants undergo post-treatment testing including brain MRI, autonomic function test (AFT), and nutrient drink test (NDT) to assess the impact of CBT

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments up to 12 weeks post-treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy
Trial Overview 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.
How Is the Trial Designed?
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 for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Cognitive Behavioral Therapy for:
  • Anxiety disorders
  • Depressive disorders
  • Eating disorders
  • Post-traumatic stress disorder (PTSD)
  • Obsessive-compulsive disorder (OCD)
๐Ÿ‡บ๐Ÿ‡ธ
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
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada 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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Published Research Related to This Trial

Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.
Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.
Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy.Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]
Cognitive Behavioral Therapy (CBT) employs active and collaborative strategies, such as cognitive restructuring, to help patients identify and change unhelpful thoughts that contribute to emotional distress.
CBT also includes techniques like behavioral activation to encourage engagement in pleasurable activities, exposure therapy to reduce fear responses, and problem-solving to systematically tackle life challenges, making it a comprehensive approach for treating various mental health issues.
Basic Strategies of Cognitive Behavioral Therapy.Wenzel, A.[2018]
Cognitive Behavioral Therapy (CBT) effectively improves dysfunctional thinking and helps individuals manage daily life problems, making it a valuable treatment option in psychiatric settings.
Key components of CBT include techniques like behavior activation and cognitive restructuring, as well as the importance of case formulation and building therapeutic relationships, which enhance its effectiveness.
[Cognitive Behavioral Therapy for Depression].Ono, Y.[2019]

Citations

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]
Basic Strategies of Cognitive Behavioral Therapy. [2018]
[Cognitive Behavioral Therapy for Depression]. [2019]
Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. [2021]
[Cognitive therapy/cognitive behavior therapy for depression]. [2022]
Dialectical behavior therapy: current indications and unique elements. [2021]
Dialectical behavior therapy: current status, recent developments, and future directions. [2022]
The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. [2018]
Current and Emerging Medical Therapies for Gastroparesis. [2020]
The effects of comprehensive mental intervention on the recovery time of patients with postsurgical gastroparesis syndrome. [2018]
The difficult patient with gastroparesis. [2007]
12.United Statespubmed.ncbi.nlm.nih.gov
Surgical Management for Gastroparesis. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Psychological controversies in gastroparesis: A systematic review. [2022]
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