Facing Eating Disorder Fears for Anorexia Nervosa: A Virtual Relapse Prevention Program Targeted at Approach and Avoidance Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Treatment Interview
研究概览
简要总结
FED-F is a modular treatment that enhances exposure therapy with psychoeducation and cognitive skills teaching how to face fears of (a) food, (b) weight gain, (c) interoception/body, and (d) social situations. The study goals are to (1) refine and test the acceptability and feasibility of FED-F treatment (Phase I), (2) test if this treatment outperforms treatment as usual (TAU) delivered post-acute treatment as adjunctive to stepdown specialty care (Phase II), and (3) to examine if treatment targets the hypothesized mechanism of action: approach behaviors (Phase II). These goals will lead to a highly deployable and accessible virtual treatment targeted at core AN mechanisms that predict relapse. Specific aims are to (1) refine FED-F into a fully virtual format with input from patients and stakeholders and collect preliminary data (N=10) on its feasibility and acceptability (Phase I), (2) conduct a small pilot RCT (randomized controlled trial) of FED-F (n=30) as compared to TAU (n=30; Phase II), and (3) examine if FED-F targets approach/avoidance behaviors and test if this mechanism is associated with clinical outcomes (Phase II).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Meets criteria for DSM-5 defined AN, AN partial remission, or AN full remission, Atypical Anorexia Nervosa (AAN), AAN partial remission, or AAN full remission
- •Has been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months
排除标准
- •Does not meet criteria for DSM-5 defined AN, AN partial-remission, or AN full-remission
- •High and active Suicidality
- •Active Mania
- •Active psychosis
- •Medically Compromised Status including extremely low weight (less than or equal to 75% median BMI for age, sex, and height)
- •Does not meet criteria for DSM-5 defined AN, AN partial remission, or AN full remission, AAN, AAN partial remission, or AAN full remission
- •Has not been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months
研究组 & 干预措施
Facing Eating Disorder Fears Condition
Participants will complete 1 session of education about the treatment. After completion of treatment education and baseline questionnaires, participants will complete sessions 2 through 12 of virtual treatment for anorexia nervosa and mobile assessments.
干预措施: Facing Eating Disorder Fears Condition (Behavioral)
Treatment as Usual
Participants will complete baseline measures, mobile assessments and treatment as usual.
结局指标
主要结局
Change in Treatment Interview
时间窗: Up to 2-month follow-up
The Treatment Interview will assess all current and past treatment experiences (partial hospitalization, residential, etc.), as well as dates of treatment. It will also assess primary type of treatment (CBT vs supportive), as well as current usage of psychotropic medications and duration of illness.
Change in Eating Disorder Examination Questionnaire 6.0 (EDE-Q)
时间窗: Up to 2-month follow-up
The EDE-Q assesses ED behaviors, thoughts, and outcomes (e.g., fasting, binge eating). The EDE-Q has demonstrated excellent test-retest reliability, internal consistency, good criterion validity and concurrent validity.
Change in Structured Clinical Interview for DSM-5 (SCID-5)
时间窗: Up to 2-month follow-up
The SCID-5 is a semi-structured interview used to arrive at DSM-5 diagnoses. Participants will complete the ED, anxiety, depression, mania, psychosis, and suicide modules. SCID-5 has strong psychometric properties.
Change in Eating Disorder Fear Inventory (EFI)
时间窗: Up to 2-month follow-up
EFI is a semi-structured interview used to assess ED fears, such as fear of weight gain, food, and associated consequences. It will be used to generate fears to focus on during treatment and comprehensively assesses all domains of ED fear.
Change in Fear of Food Measure (FOFM)
时间窗: Up to 2-month follow-up
The FOFM is a measure that assesses three cognitive-behavioral dimensions of fear of food: anxiety about food, food avoidance behaviors, and feared concerns (e.g., fear of weight gain). It has strong factor, convergent, divergent, and construct validity.
Change in Eating Disorder Fear Questionnaire (EFQ)
时间窗: Up to 2-month follow-up
The EFQ is a measure of five central ED fears: fear of weight gain, fear of social eating, fear of physical sensations, fear of social consequences (from gaining weight), fear of personal consequences (from gaining weight). EFQ has strong factor, convergent, and construct validity and assesses multiple domains of ED fear.
次要结局
- Change in Subjective Units of Distress (SUDS)(Up to session 12)
- Change in State Fear of Food Measure(Up to Session 12)
- Change in Behavioral Approach Task(Up to 2-month follow-up)
- Change in Behavioral Inhibition System/Behavioral Activation System (BIS/BAS)(Up to 2-month follow-up)
- Change in Mobile Assessment of Approach and Avoidance(Up to Session 12)
研究者
Cheri Levinson
Associate Professor
University of Louisville