Cognitive Behavioral Therapy for Gastroparesis

Overseen By Rebecca Karlson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropic, Opioids, Illicit drugs

Disqualifiers: Obstruction, Inflammatory bowel, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

29 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 11 12 13}

Who Is on the Research Team?

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) ≥ 17.5 kg/m2

Speak, write, and understand English

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

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?

Group I: Cognitive Behavioral Therapy Experimental Treatment 1 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:

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)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive Behavioral Therapy for Depression]. Ono, Y.[2019]

A pilot study involving 196 primary care patients found that 20% enrolled in an Internet-delivered cognitive behavioral therapy (CBT) program, indicating that integrating such programs into healthcare systems is feasible.

Participants who completed the program experienced a significant average reduction of 46% in depressive symptoms after four months, along with a decrease in suicidal thoughts, suggesting that Internet-delivered CBT can be an effective treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. Whiteside, U., Richards, J., Steinfeld, B., et al.[2021]

Cognitive behavior therapy (CBT) is an effective short-term treatment that helps change negative thought patterns, gaining recognition from both professionals and the public.

Since April 2010, CBT has been covered by Japan's national health insurance, highlighting its importance and acceptance as a valuable mental health intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive therapy/cognitive behavior therapy for depression]. Ono, Y., Fujisawa, D., Nakagawa, A., et al.[2022]

Dialectical behavior therapy (DBT) is an effective, evidence-based treatment specifically designed for borderline personality disorder (BPD), particularly benefiting parasuicidal women, but also showing promise for those with substance use disorders and binge-eating disorder.

DBT incorporates unique elements such as a focus on emotions, a dialectical philosophy, and mindfulness techniques, which differentiate it from other cognitive-behavioral therapies and are essential for its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy: current indications and unique elements. Chapman, AL.[2021]

Dialectical behavior therapy (DBT) has been effectively adapted for various populations beyond its original use for parasuicidal women with borderline personality disorder, showing positive outcomes in settings such as outpatient care, inpatient treatment, and crisis intervention.

Outcome studies indicate that DBT is beneficial for a range of issues, including substance use disorders, suicidal behavior in adolescents, eating disorders, and even in correctional facilities, highlighting its versatility and effectiveness across different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy: current status, recent developments, and future directions. Robins, CJ., Chapman, AL.[2022]

Cognitive-behavioral therapy (CBT) is based on scientific experimentation rather than just theories, making it a unique and evidence-based approach to treatment.

Recent research at the University of Minnesota has integrated new neuroscientific findings with CBT, potentially enhancing its effectiveness and understanding in therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. Kushner, MG.[2018]

Gastroparesis is a complex condition often linked to surgeries, medications, and diabetes, characterized by delayed gastric emptying, which is diagnosed using standardized scintigraphy.

Current treatments focus on managing symptoms and improving gastric emptying, but there is a need for future research to identify specific patient subgroups that may respond better to different therapies based on their unique underlying causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and Emerging Medical Therapies for Gastroparesis. Zhao, X., Mashimo, H.[2020]

A randomized controlled trial involving 120 patients with postsurgical gastroparesis syndrome showed that comprehensive mental intervention significantly reduced depression levels and improved recovery times compared to conventional therapy alone.

Patients receiving mental intervention experienced faster symptom relief, shorter hospital stays, and lower hospital costs, highlighting the importance of addressing psychological factors in postsurgical recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of comprehensive mental intervention on the recovery time of patients with postsurgical gastroparesis syndrome. Liu, Y., Song, X., Zhang, Y., et al.[2018]

Gastroparesis is challenging to diagnose and manage due to the lack of established criteria and the poor correlation between symptoms and gastric emptying rates, making treatment options limited.

Prokinetic therapies are commonly attempted for management, but their effectiveness varies; in severe cases, more invasive treatments like botulinum toxin injections or gastric electrical stimulation may be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The difficult patient with gastroparesis. Tack, J.[2007]

Gastroparesis is a chronic condition that often requires interventions beyond conservative management, with options ranging from feeding tubes to major surgeries like pyloromyotomy and gastrectomy.

Current treatment algorithms and outcomes data suggest that while conservative measures are important, a significant number of patients may benefit from more invasive procedures to improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Management for Gastroparesis. Zihni, AM., Dunst, CM., Swanström, LL.[2019]

In a review of studies involving 2076 gastroparesis patients, it was found that 24% experienced combined anxiety and depression, with significant levels of psychological distress correlating with the severity of their symptoms.

Patients with gastroparesis reported a lower quality of life compared to population norms, and one study suggested that psychological interventions could improve both depression and gastric function, although this study had methodological limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological controversies in gastroparesis: A systematic review. Woodhouse, S., Hebbard, G., Knowles, SR.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Basic Strategies of Cognitive Behavioral Therapy. [2018]

3. Japan pubmed.ncbi.nlm.nih.gov

[Cognitive Behavioral Therapy for Depression]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

[Cognitive therapy/cognitive behavior therapy for depression]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy: current indications and unique elements. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy: current status, recent developments, and future directions. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Current and Emerging Medical Therapies for Gastroparesis. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The effects of comprehensive mental intervention on the recovery time of patients with postsurgical gastroparesis syndrome. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The difficult patient with gastroparesis. [2007]

12. United States pubmed.ncbi.nlm.nih.gov

Surgical Management for Gastroparesis. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Psychological controversies in gastroparesis: A systematic review. [2022]