Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
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|ClinicalTrials.gov Identifier: NCT05587127|
Recruitment Status : Recruiting
First Posted : October 19, 2022
Last Update Posted : December 5, 2022
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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)
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
|Contact: Rhea Saini, BA||617-643-7884||GIbehavioralresearch@mgh.harvard.edu|
|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|
|Principal Investigator:||Helen Burton Murray, PhD||Massachusetts General Hospital|
|Responsible Party:||Helen B. Murray, PHD, Principal Investigator, Massachusetts General Hospital|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Feeding and Eating Disorders
Avoidant Restrictive Food Intake Disorder
Signs and Symptoms, Digestive