GastroparesisNCT03531450
Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients
A study testing Cognitive Behavioral Therapy in people with Gastroparesis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a single-center pilot study to be conducted at Massachusetts General Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and catastrophizing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroparesis
- 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
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 - 65 years old (inclusive)
- Symptoms of gastroparesis of at least 12 weeks duration (do not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
- An idiopathic etiology
- GES of solids using 4 hours Egg Beaters® protocol within the last 2 years with either:
- Abnormal gastric emptying rate defined as an abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) result based on a 4 hour scintigraphic low fat Egg Beaters® gastric emptying study.
- Body mass index (BMI) ≥ 17.5 kg/m2
Show all 10Show fewer
- Have not previously received CBT for coping with chronic illness
- Have access to a computer with internet access
- Speak, write, and understand English
- On stable doses of any medication for 30 days prior to entering the study (exceptions are psychotropic, opioids, and/or illicit drugs) and agrees not to change medications or dosages during the study period.
Who cannot join
- Inability to comply with or complete GES test (including allergy to eggs)
- Use of narcotic analgesics greater than three days per week
- Presence of other conditions that could explain the patient's symptoms:
- Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or abdominal CT scan
- Active inflammatory bowel disease
- Known eosinophilic gastroenteritis or eosinophilic esophagitis
Show all 45Show fewer
- Primary neurological conditions that could cause nausea and/or vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
- Acute liver failure
- Acute renal failure
- Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
- Prior gastric surgery to restore function or relieve GI symptoms including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, or gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patients with prior (Nissen, Dor, or Toupet) fundoplication will be eligible for enrollment.
- Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, active GERD or infectious gastroenteritis.
- Any acute gastrointestinal process.
- Any other plausible structural or metabolic cause
- Any condition, which in the opinion of the investigator, would interfere with study requirements
- Inability to provide informed consent
- BMI more than 32 and/or weight > 235 lbs. (limits of the MRI table)
- Enteral or parenteral feeding
- Epilepsy or a prior history of seizures
- Pregnancy or nursing
- Psychotherapy initiated in the last 8 weeks
- Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject's medical history. Subjects with the following characteristics/disease will not be eligible to participate in the study:
- History of Head Trauma
- Any metallic implants (e.g. braces or permanent retainers)
- Tattoos with metallic ink above the nipple line
- Surgical Aneurysm Clips
- Cardiac Pacemaker
- Prosthetic Heart Valve
- Neurostimulator
- Implanted pumps
- Cochlear Implants
- Metal rods, Plates
- Screws
- Recent Previous Surgery
- IUD
- Hearing Aid
- Dentures (which might create NMR artifacts)
- Metal Injury to eyes
- Pregnancy or plans to become pregnant
- Breast Feeding
- Meniere's Disease
- Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control)
- Claustrophobia
- Suicidal ideation as indicated from the HADS
- All concomitant medications taken during the study will be recorded in the case report form, along with dosage information and start and stop dates. Patients requiring excluded drugs will be discontinued from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This is a single-center pilot study to be conducted at Massachusetts General Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and catastrophizing. CBT trial patients will undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function test (AFT), gastric emptying scintigraphy (GES), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.
Read the detailed description
This randomized, controlled trial will examine the effects of cognitive behavioral therapy (CBT) on gastroparesis symptoms (including pain related brain circuitry). CBT reduces pain intensity, negative affect, and disability among patients with chronic pain, though there is a good deal of individual variability in treatment effects. Treatment gains following CBT are maintained or enhanced at 6 to 12-month follow-up. This study will examine the brain circuitry underlying these effects. In addition, as measures of gastroparesis symptoms and pain are correlated with other, more general, measures of negative affect (e.g., depression, anxiety), we will evaluate the specificity of the hypothesized effects by running the proposed statistical models both with and without inclusion of these conceptually overlapping factors. Based on pervious findings and published data, we expect that treatment-associated changes in pain and depression will likely share 10-20% of their variance.
Treatment sessions will use active, structured techniques to alter distorted thoughts, with a focus on acquiring and practicing cognitive and emotional modulatory skills. CBT is based on a pain self-management paradigm, and involves the identification and reduction of maladaptive pain-related cognitions (i.e., catastrophizing) using techniques such as relaxation, thought-stopping, distraction, etc. CBT prominently emphasizes in-vivo practice during each session, and features home practice using written exercises. In particular, cognitive restructuring is used to help patients recognize the relationships between thoughts, feelings and behaviors. Patients learn to identify, evaluate, and challenge negative thoughts. In our protocol, each of the 8 weekly sessions will last for approximately 90 minutes and will be conducted or supervised by a trained psychologist. Following CBT, negative emotions are no longer closely linked to pain, suggesting that CBT provides patients with the skills to modulate and buffer their negative emotions such as catastrophizing.
Subjects will undergo pre- and post-treatment testing through a variety of methods including brain MRI with associated physiological data, autonomic function test (AFT), gastric emptying scintigraphy (GES), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.
- Conditions
- Gastroparesis
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Gastroparesis
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Treatment sessions will use active, structured techniques to alter distorted thoughts, with a focus on acquiring and practicing cognitive and emotional modulatory skills. In particular, cognitive restructuring is used to help patients recognize the relationships between thoughts, feelings, and behaviors. Patients learn to identify, evaluate, and challenge negative thoughts. Patients will also learn behavioral strategies to decrease avoidance behavior and increase toleration of physical sensations.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Patients in the cognitive behavioral therapy group will be asked to undergo a 8-week CBT trial. An online videoconferencing link will be used to deliver CBT virtual sessions that will be approximately 60 minutes in length. Each session will be conducted by a clinical psychology doctoral student, supervised by a licensed psychologist. Patients will also undergo careful phenotyping pre- and post intervention with brain MRI, AFT, and NDT. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM)
One of the primary endpoints will be change in gastroparesis symptom severity by the Gastroparesis Cardinal Symptom Inventory (GCSI). The GCSI is comprised of three subscales: post-prandial fullness/early satiety, nausea/vomiting, and bloating. A one-point decrease in the GCSI has been validated to indicate clinically significant improvement.
Measured: Up to 12 weeks
Secondary outcomes (22)
Gastrointestinal symptom assessment via Short Form 36 Health Survey
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life
Another primary endpoint will be a change in gastroparesis-related quality of life, as assessed by the Patient Assessment of Gastrointestinal Symptoms - Quality of Life (PAGI-QOL).
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Rome III Diagnostic Questionnaire for Adult Functional GI Disorders
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Hospital Anxiety and Depression Scale
The HADS contains subscales for anxiety and depression (7 items each, scored 0-3) and will be used to explored as a potential moderator of treatment outcome.
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Patient Health Questionnaire
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via PainDETECT
The questionnaire is scored on a scale of 0-38. Scores of 0-12 indicate that a neuropathic pain component is unlikely (>15%), scores of 13-18 are ambiguous, however a neuropathic pain component can be present, and scores of 18-36 indicate that a neuropathic pain component is likely (>90%). We will use the PainDETECT to explore neuropathic pain severity as a potential moderator of treatment outcome
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Pain Catastrophizing Scale
This questionnaire assesses a patient's level of pain-related worry across three areas: rumination, helplessness, and magnification. The questionnaire lists 12 reactions to pain and asks subjects to identify how often they have these reactions on a scale of 0-4, for a maximum possible total score of 56. We will use the Pain Catastrophizing Scale to explore pain-related worry as a potential mechanism of change in CBT.
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Neuropathy Total Symptoms Score
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via PTSD Questionnaire - PCL-5
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Brief Pain Inventory
This questionnaire assesses pain in gastroparesis patients
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Early Life Trauma Inventory Self Report - Short Form
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Coping Strategies Questionnaire
This questionnaire assess an array of pain coping methods such as distraction
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Pain Self-Efficacy Questionnaire
This questionnaire measures perceived self-efficacy for managing various aspects of pain.
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Eysenck Personality Inventory
Measured: Up to 12 weeks
Gastrointestinal symptom assessment via Perceived Stress Scale
Measured: Up to 12 weeks
Structural fMRI, resting fMRI, fMRI during catastrophizing test
Measured: Baseline, and up to 2 hours post-intervention
Multivoxel 3D Proton Resonance Spectroscopy
Measured: Baseline, and up to 2 hours post-intervention
Autonomic Function Testing (AFT)
We will use an autonomic functioning test (AFT) using the ANX 3,0 autonomic monitoring system. Autonomic parameters computed by the ANX 3.0 system included the following parameters: sympathetic activity (LFa), parasympathetic activity (RFa), and sympathovagal balance (LFa/RFa). We will use the AFT to explore autonomic function as a potential mechanism of change in CBT.
Measured: Baseline, and up to 1 hour post-intervention
Abdominal Quantitative Sensory Testing (QST)
The QST assesses subject response to sharp prick and pressure sensations on the arm, finger, and abdomen. We will examine temporal summation from the abdominal QST as a potential mechanism of change in CBT.
Measured: Baseline, and up to 1 hour post-intervention
Electrogastrogram acquired during MRI scans
Measured: Baseline, and up to 2 hour post-intervention
Electrocardiogram acquired during MRI scans
Measured: Baseline, and up to 2 hour post-intervention
Respiration during MRI scans
Measured: Baseline, and up to 2 hour post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start7 Dec 2018
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
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
- NCT03531450
- Sponsor's protocol ID
- 2018P000904
- Other IDs
- U01DK112193
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2018
- Last updated
- 25 Jun 2026
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients
- ClinicalTrials.gov ID
- NCT03531450
- Acronym / sponsor ID
- 2018P000904
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 21 May 2018 (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.
This is a single-center pilot study to be conducted at Massachusetts General Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and catastrophizing. CBT trial patients will undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function test (AFT), gastric emptying scintigraphy (GES), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.
Detailed description
This randomized, controlled trial will examine the effects of cognitive behavioral therapy (CBT) on gastroparesis symptoms (including pain related brain circuitry). CBT reduces pain intensity, negative affect, and disability among patients with chronic pain, though there is a good deal of individual variability in treatment effects. Treatment gains following CBT are maintained or enhanced at 6 to 12-month follow-up. This study will examine the brain circuitry underlying these effects. In addition, as measures of gastroparesis symptoms and pain are correlated with other, more general, measures of negative affect (e.g., depression, anxiety), we will evaluate the specificity of the hypothesized effects by running the proposed statistical models both with and without inclusion of these conceptually overlapping factors. Based on pervious findings and published data, we expect that treatment-associated changes in pain and depression will likely share 10-20% of their variance.
Treatment sessions will use active, structured techniques to alter distorted thoughts, with a focus on acquiring and practicing cognitive and emotional modulatory skills. CBT is based on a pain self-management paradigm, and involves the identification and reduction of maladaptive pain-related cognitions (i.e., catastrophizing) using techniques such as relaxation, thought-stopping, distraction, etc. CBT prominently emphasizes in-vivo practice during each session, and features home practice using written exercises. In particular, cognitive restructuring is used to help patients recognize the relationships between thoughts, feelings and behaviors. Patients learn to identify, evaluate, and challenge negative thoughts. In our protocol, each of the 8 weekly sessions will last for approximately 90 minutes and will be conducted or supervised by a trained psychologist. Following CBT, negative emotions are no longer closely linked to pain, suggesting that CBT provides patients with the skills to modulate and buffer their negative emotions such as catastrophizing.
Subjects will undergo pre- and post-treatment testing through a variety of methods including brain MRI with associated physiological data, autonomic function test (AFT), gastric emptying scintigraphy (GES), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyPatients in the cognitive behavioral therapy group will be asked to undergo a 8-week CBT trial. An online videoconferencing link will be used to deliver CBT virtual sessions that will be approximately 60 minutes in length. Each session will be conducted by a clinical psychology doctoral student, supervised by a licensed psychologist. Patients will also undergo careful phenotyping pre- and post intervention with brain MRI, AFT, and NDT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients aged 18 - 65 years old (inclusive)
- Symptoms of gastroparesis of at least 12 weeks duration (do not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
- An idiopathic etiology
- GES of solids using 4 hours Egg Beaters® protocol within the last 2 years with either:
- Body mass index (BMI) ≥ 17.5 kg/m2
Key exclusion criteria (45 listed)
- Inability to comply with or complete GES test (including allergy to eggs)
- Use of narcotic analgesics greater than three days per week
- Presence of other conditions that could explain the patient's symptoms:
- Inability to provide informed consent
- BMI more than 32 and/or weight > 235 lbs. (limits of the MRI table)
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 TherapyTreatment sessions will use active, structured techniques to alter distorted thoughts, with a focus on acquiring and practicing cognitive and emotional modulatory skills. In particular, cognitive restructuring is used to help patients recognize the relationships between thoughts, feelings, and behaviors. Patients learn to identify, evaluate, and challenge negative thoughts. Patients will also learn behavioral strategies to decrease avoidance behavior and increase toleration of physical sensations. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM)
Time frame: Up to 12 weeks
One of the primary endpoints will be change in gastroparesis symptom severity by the Gastroparesis Cardinal Symptom Inventory (GCSI). The GCSI is comprised of three subscales: post-prandial fullness/early satiety, nausea/vomiting, and bloating. A one-point decrease in the GCSI has been validated to indicate clinically significant improvement.
22 secondary outcomes
Gastrointestinal symptom assessment via Short Form 36 Health Survey
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Rome III Diagnostic Questionnaire for Adult Functional GI Disorders
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Hospital Anxiety and Depression Scale
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Patient Health Questionnaire
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via PainDETECT
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Pain Catastrophizing Scale
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Neuropathy Total Symptoms Score
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via PTSD Questionnaire - PCL-5
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Brief Pain Inventory
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Early Life Trauma Inventory Self Report - Short Form
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Coping Strategies Questionnaire
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Pain Self-Efficacy Questionnaire
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Eysenck Personality Inventory
Time frame: Up to 12 weeks
Gastrointestinal symptom assessment via Perceived Stress Scale
Time frame: Up to 12 weeks
Structural fMRI, resting fMRI, fMRI during catastrophizing test
Time frame: Baseline, and up to 2 hours post-intervention
Multivoxel 3D Proton Resonance Spectroscopy
Time frame: Baseline, and up to 2 hours post-intervention
Autonomic Function Testing (AFT)
Time frame: Baseline, and up to 1 hour post-intervention
Abdominal Quantitative Sensory Testing (QST)
Time frame: Baseline, and up to 1 hour post-intervention
Electrogastrogram acquired during MRI scans
Time frame: Baseline, and up to 2 hour post-intervention
Electrocardiogram acquired during MRI scans
Time frame: Baseline, and up to 2 hour post-intervention
Respiration during MRI scans
Time frame: Baseline, and up to 2 hour post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
Related trials for Gastroparesis
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
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. This study is not recruiting at the moment.
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 Gastroparesis, 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 45 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: finished, as of the sponsor's last update on 25 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) (time frame: Up to 12 weeks). 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 Jun 2026.