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
- 2
- 主要终点
- Retention
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
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.
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.
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