Meal-Based Exposure and Response Prevention in Anorexia Nervosa: Reducing Physiological and Self-reported Food-Related Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in amount of high calorie diet consumption
研究概览
简要总结
Patients with anorexia nervosa (AN), a serious psychiatric disorder, exhibit restricted dietary intake and endorse fear of consuming calorie-dense foods, which in turn drives weight loss. Premorbid anxious personality traits and comorbid anxiety disorders are common in patients with AN. Although intensive behavioral treatment programs can achieve weight restoration in a majority of adults with AN, relapse rates are high. Predictors of relapse include elevated state anxiety and low dietary variety, including lower intake of fat, after discharge, which suggests that relapse following weight restoration may be related to inadequate fear extinction to high energy density (ED) foods during treatment and consequent resumption of restrictive eating patterns. Despite evidence of anxiety's role in the onset and maintenance of restricted eating behavior, utilizing exposure and response prevention (EX-RP) and meal-based interventions to reduce food-related fears is understudied. EX-RP is the gold standard of treatment for Obsessive Compulsive Disorder (OCD). This proposal aims to test the efficacy of an adjunct meal-based EX-RP intervention to reduce food-related fears during intensive behavioral weight restoration in hospitalized patients with AN in comparison to a control treatment, Motivational Interviewing. The investigators will assess changes in a) self-reported anxiety regarding consumption of high-ED foods, b) physiological (skin conductance and heart rate variability) responses to imagined consumption of food items elicited utilizing a visual food cue task, and c) caloric intake of a challenging test meal pre- and post-treatment. A secondary aim is to assess the relationship of early treatment response to EX-RP, operationalized as a reduction in self-reported anxiety within the first three weeks of treatment, and end-of-treatment as well as six-month post-discharge outcomes. Helping patients tolerate food-related anxiety and increase dietary variety across meal contexts may augment treatment effectiveness in adult patients during intensive treatment for AN and has potential to decrease relapse rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 criteria for AN or Other Specified Feeding and Eating Disorder.
- •Body Mass Index (BMI) > 14.0 kg/m2 and < 20.0 kg/m2
- •Age > 12 years, < 66 years
- •Fluency in the English language
- •Exclusion criteria:
- •Diagnosis of schizophrenia, schizophreniform disorder, bipolar illness (type I) with active psychotic symptoms
- •History of traumatic brain injury with current impairment in functioning
- •Current use of benzodiazepines, as these medications may alter psychophysiological assessment
- •Allergy to dairy products or chocolate contained in the test meal
排除标准
- 未提供
结局指标
主要结局
Change in amount of high calorie diet consumption
时间窗: At week 2 of treatment and at discharge, up to 10 weeks
Patients will be asked to consume a meal (1,066 kcal) consisting of calorie dense foods over a period of 45 minutes. Total caloric intake will be measured by weighing food items prior to and following the meal and identifying the proportion of the meal in kcal consumed.
Change in Physiological Anxiety in Response to Food Images as assessed by Skin Conductance Response
时间窗: Pre-treatment and post-treatment up to 10 weeks
Participants will view images of low- and high-ED foods, and of office products for 8 seconds each. Skin Conductance Response (microsiemens) will be recorded from electrodes placed on the palmar surface of the middle phalanges of the 2nd and 3rd fingers on the non-dominant hand.
Change in Physiological Anxiety in Response to Food Images as assessed by Heart rate variability
时间窗: Pre-treatment and post-treatment up to 10 weeks
Participants will view images of low- and high-ED foods, and of office products for 8 seconds each. Heart rate variability will be measured using ECG electrodes placed in a diagonal axis across the heart region, with a reference electrode on the stomach.
次要结局
- Change in food Choice Preferences as assessed by The Food Choice Task(Pre-treatment and post-treatment up to 10 weeks)
- Eating Disorder Examination Questionnaire Scores(Pre-treatment and post-treatment up to 10 weeks)
- Change in food related anxiety as assessed by the Food Anxiety Questionnaire.(Weekly up to 10 weeks)