Evaluating Open Weighing and Blind Weighing in the Treatment of Adolescents and Young Adults With Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Body Shape Questionnaire (BSQ)
研究概览
简要总结
Current treatments for adolescents and young adults (AYAs) with eating disorders (EDs) do not effectively address a central ED symptom - anxiety about weight gain - which contributes to poor outcomes. The proposed study evaluates the feasibility, acceptability, efficacy, and underlying mechanisms of an enhanced version of "open weighing," a cognitive-behavioral intervention designed to target anxiety about weight gain in AYAs with EDs. Understanding how to better treat AYAs with EDs, and identifying the mechanisms by which interventions lead to improvement, will aid in the development of more effective and personalized treatments, ultimately improving the lives of AYAs with EDs.
详细描述
The proposed study evaluates the feasibility, acceptability, efficacy, and underlying mechanisms of an enhanced version of "open weighing" (OW), a cognitive-behavioral intervention designed to target anxiety about weight gain in adolescents and young adults (AYAs) with eating disorders (EDs). OW will be compared to an alternative intervention, "blind weighing" (BW), in which individuals are discouraged from seeing, thinking, or talking about their weight. Understanding how to better treat AYAs with EDs, and identifying the mechanisms by which interventions lead to improvement, will aid in the development of more effective and personalized treatments, ultimately improving the lives of AYAs with EDs.
Aim 1. Evaluate the feasibility and acceptability of OW and BW for AYAs with EDs.
Hypothesis 1.1: Both OW and BW will be feasible, with no significant differences in rates of recruitment or retention.
Hypothesis 1.2: Both treatments will be rated as highly acceptable, with no significant differences in measures evaluating the acceptability or attitudes about OW and BW.
Aim 2. Test the efficacy of OW and BW. Hypothesis 2.1: OW will result in significantly greater improvements in body mass index and ED symptomatology than BW.
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
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be English speakers.
- •Participants must be between the ages of 12 - 24 years who have been admitted to either the adolescent or young adult Partial Hospital Program (PHP) for eating disorders (EDs) at Penn State Hershey.
- •Participants must also present with an eating disorder (ED) diagnosis that is characterized by anxiety about weight gain, such as anorexia nervosa (AN), Bulimia nervosa (BN), or their subthreshold presentations captured under the other specific feeding or eating disorder (OSFED) category.
排除标准
- •Participants will be excluded if they are above the age of 24 or below the age of 12 years.
- •Participants who have been identified as non-English speakers.
- •Participants with cognitive impairment will also be excluded from participation.
- •Potential participants will be excluded if they do not meet the diagnostic inclusion criteria noted above.
- •individuals with a diagnosis of avoidant/restrictive food intake disorder, as these individuals do not experience anxiety about weight gain will be excluded.
结局指标
主要结局
Body Shape Questionnaire (BSQ)
时间窗: Discharge: No longer than 60 weeks
The BSQ is a self-reported measurement of the body shape concerns typical of bulimia nervosa and anorexia nervosa. The questionnaire has 34 items scored from 0 to 6 points (least and most impaired, respectively), with the sum of the questions giving a range from 0 to 204.
Body Image States Scale (BISS)
时间窗: Admission_Baseline
The Body Image State Scale (BISS) is a 6-item measure designed to assess body dissatisfaction. The questionnaire is rated on a seven-point scale ranging from "very satisfied" to very dissatisfied".
Eating Disorder-15 (ED-15)
时间窗: Discharge: No longer than 60 weeks
The Eating Disorder-15 (ED-15) is a 15-item measure designed to assess eating psychopathology levels over the preceding week. The 10 items scored from 0 to 6 points (least and most impaired, respectively), with the sum of the questions giving a range from 0 to 6. The additional 5 items focused on the number of days individuals participated in a given behavior, such as the use of laxatives and restrictive eating.
Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)
时间窗: Discharge: No longer than 60 weeks
The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-report questionnaire. It was designed to assess the range, frequency, and severity of behaviors associated with a diagnosis of an eating disorder. A total score is obtained by summing the four subscales scores and dividing the total by the number of subscales. The score of items are calculated and range from 0 to 36. The higher score indicate greater ED symptoms.
Fear of Food Measure (FOFM)
时间窗: Discharge: No longer than 60 weeks
The Fear of Food Measure (FORM) is a 23-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. Each item is scored on a 1-7 scale. The questionnaire range from 23 to 161 meaning 23: no fear of food and 161 meaning severe fear of food.
Eating Disorder Fear Questionnaire (EDFQ)
时间窗: Discharge: No longer than 60 weeks
The Eating Disorder Fear Questionnaire (EDFQ) is a 20-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. The response range between 1 to 7 with a total range of 20 to 140. The higher rating indicating a higher severe impairment.
Approach / Avoidance of weighing Questionnaire (AAWQ)
时间窗: Admission_Baseline
The Approach / Avoidance of Weighing Questionnaire (AAWQ) is a 9-item measure designed to assess approach and avoidance weighing tendency. The three descriptive items are not included in the approach/avoidance weighing tendencies calculation. Items 1-3 correspond to approach weighing tendency, and items 4-6 correspond to avoidance weighing tendency. Items are scored as follows for both subscales: Totally true of me = 5; Somewhat true of me = 4; Neither true nor untrue of me = 3; Somewhat untrue of me = 2; Totally untrue of me = 1. Items 1-3 are summed to provide the approach weighing tendency subscale and items 4-6 are summed to provide the avoidance weighing tendency subscale, with scores ranging from 3-15. Higher scores on each subscale indicate a higher degree of that subscale's weighing tendency.
Clinical Impairment Assessment (CIA)
时间窗: Discharge: No longer than 60 weeks
The Clinical Impairment Assessment Questionnaire (CIA) is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features and focuses on the past 28 days. The 16 items cover impairment in domains of life that are typically affected by eating disorder psychopathology: mood and self-perception, cognitive functioning, interpersonal functioning, and work performance. The response are scored 0,1,2 and 3 with a higher rating indicating a higher level of impairment. The total range is between 0 and 48.
Eating Disorder-15 (ED 15)
时间窗: Admission_Baseline
The Eating Disorder-15 (ED-15) is a 15-item measure designed to assess eating psychopathology levels over the preceding week. The 10 items scored from 0 to 6 points (least and most impaired, respectively), with the sum of the questions giving a range from 0 to 6. The additional 5 items focused on the number of days individuals participated in a given behavior, such as the use of laxatives and restrictive eating.
Body Image State Scale (BISS)
时间窗: Discharge: No longer than 60 weeks
The Body Image State Scale (BISS) is a 6-item measure designed to assess body dissatisfaction. The questionnaire is rated on a seven-point scale ranging from "very satisfied" to very dissatisfied".
Approach / Avoidance of Weighing Questionnaire (AAWQ)
时间窗: Discharge: No longer than 60 weeks
The Approach / Avoidance of Weighing Questionnaire (AAWQ) is a 9-item measure designed to assess approach and avoidance weighing tendency. The three descriptive items are not included in the calculation of approach/avoidance weighing tendencies. The items 1-3 correspond to approach weighing tendency, and items 4-6 correspond to avoidance weighing tendency. Items are scored as follows for both subscales: Totally true of me = 5; Somewhat true of me = 4; Neither true nor untrue of me = 3; Somewhat untrue of me = 2; Totally untrue of me = 1. Items 1-3 are summed to provide the approach weighing tendency subscale and items 4-6 are summed to provide the avoidance weighing tendency subscale, with scores ranging from 3-15. Higher scores on each subscale indicate a higher degree of that subscale's weighing tendency.
次要结局
- Personal Reactions to the Rationale questionnaire (PRR)(Admission-Baseline)
- Credibility Scale (CS)(Admission-Baseline)
研究者
Jamal Essayli
Assistant Professor of Pediatrics and Psychiatry & Behavioral Health
Milton S. Hershey Medical Center