Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
Primary Purpose
Avoidant/Restrictive Food Intake Disorder, Dyspepsia, Feeding and Eating Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional other trial for Avoidant/Restrictive Food Intake Disorder
Eligibility 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)
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive Behavioral Therapy
Usual Care
Arm Description
Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.
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.
Outcomes
Primary Outcome Measures
Enrollment
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.
Assessment completion
At the end of the study, we will calculate the percentage of participants who complete all assessments in each CBT and usual care groups.
Retention
At the end of the study, we will calculate the percentage of participants who complete at least 6 of the 8 CBT sessions.
Interventionist Fidelity ratings
At the end of the study, we will calculate fidelity, which measures the percentage of sessions that 100% of the CBT content was delivered.
Client Satisfaction
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
Short Form Nepean Dyspepsia Inventory (SF-NDI)
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.
Full Information
NCT ID
NCT05587127
First Posted
September 28, 2022
Last Updated
July 21, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05587127
Brief Title
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
Official Title
A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avoidant/Restrictive Food Intake Disorder, Dyspepsia, Feeding and Eating Disorders, Cognitive Behavioral Therapy, Appetite Regulation, Functional Dyspepsia, Post-prandial Distress Syndrome, Behavioral Medicine
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enrollment
Description
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.
Time Frame
Throughout study completion, an average of 3 years
Title
Assessment completion
Description
At the end of the study, we will calculate the percentage of participants who complete all assessments in each CBT and usual care groups.
Time Frame
Throughout study completion, an average of 3 years
Title
Retention
Description
At the end of the study, we will calculate the percentage of participants who complete at least 6 of the 8 CBT sessions.
Time Frame
Throughout study completion, an average of 3 years
Title
Interventionist Fidelity ratings
Description
At the end of the study, we will calculate fidelity, which measures the percentage of sessions that 100% of the CBT content was delivered.
Time Frame
Throughout study completion, an average of 3 years
Title
Client Satisfaction
Description
The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report measure that assesses treatment satisfaction. Higher scores indicate greater treatment satisfaction.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Short Form Nepean Dyspepsia Inventory (SF-NDI)
Description
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.
Time Frame
Weeks 0, 6, and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Age at least 18 years at screening visit
Rome IV Functional Dyspepsia post-prandial distress type (with or without epigastric pain syndrome)
Negative upper endoscopy or upper radiographic GI series to rule out structural/organic cause for FD
Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis (by the Structured Clinical Interview for DSM-5; SCID-5 at Screening visit)
≥5% weight loss from weight after functional dyspepsia symptom onset (at Screening visit)
Stable for outpatient care (based on the American Psychiatric Association Practice Guideline for the Treatment of Patients with Eating Disorders)
No previous history of CBT for functional dyspepsia or ARFID
Computer/internet webcam access
Fluency in English
Stable dose for 30 days if on any medication
Exclusion Criteria
Inability to provide informed consent
Presence of other conditions that could explain the patient's symptoms by chart:
Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT) H.pylori negative (by CLO test or stool antigen test) Active inflammatory bowel disease Eosinophilic gastroenteritis or eosinophilic esophagitis Acute renal failure Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis Acute liver failure Any acute gastrointestinal process Any plausible structural or metabolic causes Heartburn as predominant symptom History of peptic ulcer
Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)
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
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 chart
Intellectual disability by history
Current substance/alcohol use disorder within the past month
Current/history of psychosis (by Mini-International Neuropsychiatric Interview (MINI-Screen)
Current mania (by Mini-International Neuropsychiatric Interview (MINI-Screen) (defined as any manic episodes within the past 12 months)
Active suicidal ideation (by MINI-Screen)
Psychiatric disorder that would warrant independent attention (by Mini-International - Neuropsychiatric Interview (MINI-Screen))
Current enteral or parenteral feeding
Plans to initiate another psychotherapy or pregnancy in the concurrent study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blythe Peterson, BS
Phone
617-643-7884
Email
GIbehavioralresearch@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Burton Murray, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Burton Murray, PhD
Phone
617-643-7884
Email
GIbehavioralresearch@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Rhea Saini, BS
Phone
617-643-7884
Email
GIbehavioralresearch@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Helen Burton Murray, PhD
12. IPD Sharing Statement
Learn more about this trial
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
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