Exposure-Based CBT for Avoidant/Restrictive Food Intake i... | NCT05587127

NCT05587127

ID	Type	Description	Link
K23DK131334-01	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Behavioral Therapy	Experimental	Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.	Behavioral: Cognitive Behavioral Therapy
Usual Care	No Intervention	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Behavioral Therapy	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Throughout study completion, an average of 3 years
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.	Throughout study completion, an average of 3 years
Retention	At the end of the study, we will calculate the percentage of participants who complete at least 6 of the 8 CBT sessions.	Throughout study completion, an average of 3 years
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.	Throughout study completion, an average of 3 years
Client Satisfaction	The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report measure that assesses treatment satisfaction. Higher scores indicate greater treatment satisfaction.	Week 12

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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) Active H.pylori infection (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
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

ID	Term
D000080146	Avoidant Restrictive Food Intake Disorder
D004415	Dyspepsia
D001068	Feeding and Eating Disorders

ID	Term
D001523	Mental Disorders
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities