A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Interventionist Fidelity ratings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cognitive Behavioral Therapy
Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.
干预措施: Cognitive Behavioral Therapy (Behavioral)
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.
结局指标
主要结局
Interventionist Fidelity ratings
时间窗: 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.
Enrollment
时间窗: 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
时间窗: 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.
Client Satisfaction
时间窗: Week 12
The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report measure that assesses treatment satisfaction. Higher scores indicate greater treatment satisfaction.
Retention
时间窗: 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.
次要结局
- Short Form Nepean Dyspepsia Inventory (SF-NDI)(Weeks 0, 6, and 12)
研究者
Helen B. Murray, PHD
Principal Investigator
Massachusetts General Hospital