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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

Tracking Information
First Submitted Date  ICMJE September 28, 2022
First Posted Date  ICMJE October 19, 2022
Last Update Posted Date December 5, 2022
Actual Study Start Date  ICMJE November 30, 2022
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2022)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
Official Title  ICMJE A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Avoidant/Restrictive Food Intake Disorder
  • Dyspepsia
  • Feeding and Eating Disorders
  • Cognitive Behavioral Therapy
  • Appetite Regulation
  • Functional Dyspepsia
  • Post-prandial Distress Syndrome
  • Behavioral Medicine
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Cognitive Behavioral Therapy
    Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2022)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2026
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rhea Saini, BA 617-643-7884 GIbehavioralresearch@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05587127
Other Study ID Numbers  ICMJE 2022P001765
K23DK131334-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Helen B. Murray, PHD, Massachusetts General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Helen Burton Murray, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP