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Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05587127
Recruitment Status : Recruiting
First Posted : October 19, 2022
Last Update Posted : December 5, 2022
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Helen B. Murray, PHD, Massachusetts General Hospital

Study Description
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Brief Summary:
Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant/restrictive food intake disorder (ARFID) with weight loss.

Condition or disease Intervention/treatment Phase
Avoidant/Restrictive Food Intake Disorder Dyspepsia Feeding and Eating Disorders Cognitive Behavioral Therapy Appetite Regulation Functional Dyspepsia Post-prandial Distress Syndrome Behavioral Medicine Behavioral: Cognitive Behavioral Therapy Not Applicable

Detailed Description:
The purpose of this study is to conduct a randomized controlled trial (RCT) of a cognitive-behavioral treatment (CBT) compared to usual care as the control with adults with functional dyspepsia who also meet criteria for avoidant/restrictive food intake disorder (ARFID). Participants randomized into the CBT group will receive eight 1-hour sessions delivered weekly via the MGH-approved secure video platform Enterprise Zoom while the usual care group will be allowed to continue with treatment they are already receiving at the time of randomization. Participants in the usual care group will be offered CBT after study participation. We will determine the feasibility and acceptability of the CBT and explore changes in clinical outcomes and preliminary mechanisms.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia
Actual Study Start Date : November 30, 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.
 Behavioral: Cognitive Behavioral Therapy
Eight 1-hour sessions delivered weekly via the MGH-approved secure video platform Enterprise Zoom. Skills include: education about gut-brain regulation and weight loss, and regularizing eating to improve hunger and satiety cues; techniques to facilitate weight gain with targets of increased food volume and variety; and plan for maintenance of treatment gains.
No Intervention: Usual Care
In the usual care condition, participants will be allowed to continue with treatment they are already receiving at the time of randomization, and we will collect detailed data on the nature of these interventions. Participants will be allowed to pursue non study treatments in this condition.


Outcome Measures
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Primary Outcome Measures :
  1. Enrollment [ Time Frame: Throughout study completion, an average of 3 years ]
    At the end of the study, we will calculate the percentage of participants who consent to initiate the study from the total who are offered.

  2. Assessment completion [ Time Frame: Throughout study completion, an average of 3 years ]
    At the end of the study, we will calculate the percentage of participants who complete all assessments in each CBT and usual care groups.

  3. Retention [ Time Frame: Throughout study completion, an average of 3 years ]
    At the end of the study, we will calculate the percentage of participants who complete at least 6 of the 8 CBT sessions.

  4. Interventionist Fidelity ratings [ Time Frame: Throughout study completion, an average of 3 years ]
    At the end of the study, we will calculate fidelity, which measures the percentage of sessions that 100% of the CBT content was delivered.

  5. Client Satisfaction [ Time Frame: Week 12 ]
    The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report measure that assesses treatment satisfaction. Higher scores indicate greater treatment satisfaction.


Secondary Outcome Measures :
  1. Short Form Nepean Dyspepsia Inventory (SF-NDI) [ Time Frame: Weeks 0, 6, and 12 ]
    The Short Form Nepean Dyspepsia Inventory (SF-NDI) includes a 15 item symptoms checklist to assess functional dyspepsia symptom severity. It also includes 10 items scored on a 5-point Likert scale measuring functional dyspepsia-related quality of life; subscales include interference with daily activities, knowledge/control, tension, work/study, and eating/drinking.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rome IV Functional Dyspepsia post-prandial distress syndrome subtype and/or epigastric pain syndrome subtype
  • Avoidant Restrictive Food Intake Disorder diagnosis (assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5))
  • ≥ 5% weight loss after FD onset
  • Stable for outpatient care (Assessed by APA guidelines)
  • No previous history of CBT for FD or ARFID
  • Computer/internet webcam access
  • Stable dose for 30 days if on any medication
  • Negative upper endoscopy or upper radiographic GI series within 2 years
  • Fluency in English

Exclusion Criteria:

  • Inability to provide informed consent
  • History of gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
  • History of any serious medical condition (e.g., cancer)
  • Use of narcotic analgesics greater than three days per week
  • Use of cannabinoids greater than three days per week
  • Current enteral/parenteral feeding
  • Current pregnancy or breastfeeding within the last 8 weeks
  • Systemic hormone use (other than thyroid hormone for hypothyroidism) within 8 weeks of Visit 1
  • Uncontrolled diabetes (indicated by HbA1c ≥7%) by medical chart
  • Intellectual disability by history
  • Current substance/alcohol use disorder within past month
  • Current/history of psychosis/mania (by Mini-International Neuropsychiatric Interview (MINI-Screen))
  • Psychiatric disorder that would warrant independent attention (by Mini-International Neuropsychiatric Interview (MINI-Screen))
  • Plans to initiate psychotherapy or pregnancy in concurrent study period
  • Active suicidal ideation (by MINI-Screen)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05587127


Contacts
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Contact: Rhea Saini, BA 617-643-7884 GIbehavioralresearch@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Helen Burton Murray, PhD    617-643-7884    GIbehavioralresearch@mgh.harvard.edu   
Contact: Rhea Saini, BS    617-643-7884    GIbehavioralresearch@mgh.harvard.edu   
Principal Investigator: Helen Burton Murray, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Helen Burton Murray, PhD Massachusetts General Hospital
More Information
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Responsible Party: Helen B. Murray, PHD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05587127    
Other Study ID Numbers: 2022P001765
K23DK131334-01 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Dyspepsia
Feeding and Eating Disorders
Avoidant Restrictive Food Intake Disorder
 Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive