Open vs. Blind Weighing Study In Adolescents and Young Adult With Eating Disorders

Официальное название

Evaluating Open Weighing and Blind Weighing in the Treatment of Adolescents and Young Adults With Eating Disorders

Обзор

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.

Подробное описание

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.

Hypothesis 2.2: OW will result in significantly greater decreases in anxiety about weight gain than BW.

Aim 3. Identify anxiety about weight gain as a key mechanism to target in the treatment of AYAs with EDs.

Hypothesis 3.1: Across both conditions, greater reductions in anxiety about weight gain will be associated with better outcomes at discharge.

Вмешательства

• Поведенческое Open weighing
  The open-weighing intervention aims to challenge beliefs about weight gain. The study coordinator (SC) will explain open weighing, discuss any concerns you have about your weight, and construct a weight graph with the number of weeks on the x-axis and weight in pounds on the y-axis. The SC will help identify beliefs about gaining weight, which will be written on a Feared Outcomes Form. The SC will ask you to predict your weight, mark the weight prediction on the graph, weigh you on a standing sc
• Поведенческое Blind weighing
  The blind weighing intervention aims to help you see self-weighing as an eating disorder symptom that you should stop, and that weight is not important to your identity or self-esteem. To do this, the study coordinator will explain why blind weighing might be helpful. You will then be asked to step backwards on a standing scale. The study coordinator will record your weight but will not share your weight information with you. The study coordinator will discourage you from thinking or talking abo

Первичные конечные точки

• Eating Disorder Examination - Self-Report Questionnaire (EDE-Q) [Срок оценки: Admission-Baseline]
• Fear of Food Measure (FOFM) [Срок оценки: Admission Baseline]
• Body Shape Questionnaire (BSQ) [Срок оценки: Admission- Baseline]
• Clinical Impairment Assessment (CIA) [Срок оценки: Admission- Baseline]
• Eating Disorder Fear Questionnaire (EDFQ) [Срок оценки: Admission_Baseline]
• Eating Disorder-15 (ED 15) [Срок оценки: Admission_Baseline]
• Body Image States Scale (BISS) [Срок оценки: Admission_Baseline]
• Approach / Avoidance of weighing Questionnaire (AAWQ) [Срок оценки: Admission_Baseline]
• Eating Disorder Examination - Self-Report Questionnaire (EDE-Q) [Срок оценки: Discharge: No longer than 60 weeks]
• Fear of Food Measure (FOFM) [Срок оценки: Discharge: No longer than 60 weeks]

Вторичные конечные точки (2)

• Personal Reactions to the Rationale questionnaire (PRR) [Срок оценки: Admission-Baseline]
• Credibility Scale (CS) [Срок оценки: Admission-Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• 905 W Govener Rd — Hershey

Идентификаторы

NCT: NCT06085092 · 22718

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗