Avoidant/Restrictive Food Intake DisorderNCT05587127
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
A study testing Cognitive Behavioral Therapy in people with Avoidant/Restrictive Food Intake Disorder and Dyspepsia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Avoidant/Restrictive Food Intake Disorder, Dyspepsia, Feeding and Eating Disorders
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Helen Burton Murray, PhD, 617-643-7884, GIbehavioralresearch@mgh.harvard.edu
Blythe Peterson, BS, 617-643-7884, GIbehavioralresearch@mgh.harvard.edu
About this study
Official title: A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia
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.
Read the 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.
- Conditions
- Avoidant/Restrictive Food Intake Disorder, Dyspepsia, Feeding and Eating Disorders, Cognitive Behavioral Therapy, Appetite Regulation, Functional Dyspepsia
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder, Dyspepsia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Secondary outcomes (1)
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.
Measured: Weeks 0, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start30 Nov 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avoidant/Restrictive Food Intake DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen B. Murray, PHD, Massachusetts General Hospital
- Investigators
- Helen Burton Murray, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587127
- Sponsor's protocol ID
- 2022P001765
- Other IDs
- K23DK131334-01
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05587127
- Acronym / sponsor ID
- 2022P001765
- Conditions
- Avoidant/Restrictive Food Intake Disorder, Dyspepsia, Feeding and Eating Disorders, Cognitive Behavioral Therapy, Appetite Regulation, Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapySubjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyEight 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. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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.
1 secondary outcome
Short Form Nepean Dyspepsia Inventory (SF-NDI)
Time frame: Weeks 0, 6, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen Burton Murray, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Avoidant/Restrictive Food Intake Disorder and Dyspepsia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blythe Peterson, BS (617-643-7884, GIbehavioralresearch@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Throughout study completion, an average of 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.