Adapting Exposure Therapy to Target Anxiety About Weight Gain in Adolescents With Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)
研究概览
简要总结
This pilot study is evaluating Exposure Therapy (Exp-AN) as a virtual treatment for adolescents (ages 14 - 17 years) with anorexia nervosa (AN) recruited from eating disorder clinic waitlists and clinician referrals at the Penn State Milton S. Hershey Medical Center and the University of California, San Francisco (UCSF) (8 participants per site). Adolescents who agree to take part in this study will receive 20 free virtual 40-60 minute weekly Exp-AN sessions at an outpatient level of care. Exp-AN for adolescents will combine individual virtual session time (35-50 min) with parent involvement (10-25 min). Parents will serve as "collaborators," supporting skill development, exposure completion, and treatment goal achievement. Exp-AN sessions will focus on helping participants overcome anxiety about weight gain by encouraging them to do challenging things that increase anxiety in the short term but help them better tolerate anxiety over the long term. Participants will be asked to complete a clinical interview, questionnaires, and labs and vitals testing before they begin the study. Adolescents will also complete questionnaires and participate in 15-min semi-structured interviews, while parents/caregivers will complete separate parallel interviews, at: mid-treatment, end-of-treatment, and 3-month follow-up. To ensure that all participants are receiving the same type of therapy, they will not be able to have any concurrent psychotherapy while receiving this treatment (other forms of care including dieticians, nutritionists, and psychiatrists are allowed).
Exp-AN is designed to target anxiety about weight gain. Exp-AN includes education about the effects of undereating; the importance of overcoming anxiety about weight gain; in-session weight exposures (e.g., stepping on a scale while reading a script describing fears about weight gain); creating a meal plan to help improve eating; reviewing eating behaviors over the past week; conducting in-session and between-session exposures that help participants face fears related to weight gain; and relapse prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of anorexia nervosa (AN)
- •English speaking
- •Mentally stable for an outpatient level of care
- •Living with at least one parent/caregiver
- •Less than or equal to 90% of expected body weight
排除标准
- •Younger than 14 years old or older than 17 years old
- •Has a current psychotherapist and not open to pausing treatment for the duration of the study
- •Has a diagnosis of bulimia nervosa or binge-eating disorder
- •Acutely suicidal
- •Meets DSM-5 criteria for a psychotic disorder and/or has an intellectual disability
- •Non-English speaking
研究组 & 干预措施
Exposure Therapy for AN (Exp-AN)
Exp-AN aims to target anxiety about weight gain by helping participants identify their specific feared consequences of weight gain (e.g., "I will permanently hate myself if I gain weight"), and combining in vivo (i.e., in real life) and imaginal (i.e., mental) exposure exercises to address these fears. Exp-AN consists of four core modules: (1) Treatment Rationale and Psychoeducation; (2) In-Session Weight Exposure; (3) Planning, Conducting, and Reviewing Exposures; and (4) Relapse Prevention.
干预措施: Exposure Therapy for Anorexia (Exp-AN) (Behavioral)
结局指标
主要结局
Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)
时间窗: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up
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 global score is obtained by summing the four subscales scores (ranging from 0-6) and dividing the total by the number of subscales (4). The score of items are calculated and range from 0 to 6. The higher score indicate greater ED symptoms.
Fear of Food Measure (FOFM)
时间窗: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up
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.
Body Shape Questionnaire (BSQ)
时间窗: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up
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. The higher score indicates greater concerns about body shape.
Weight Gain Anxiety Questionnaire
时间窗: Baseline, Sessions 1-20, 3-Month-Follow-Up
The Weight Gain Anxiety Questionnaire is a 12-item self-report questionnaire that targets anxiety about weight gain. The scores are measured on a 0-100 scale, with the higher the score indicating more distress about weight gain, with the exception for question 2 which is reverse scored.
Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up
The Generalized Anxiety Disorder-7 is a 7-item self-report questionnaire that targets anxiety symptoms. The scores range from 0 to 21, with higher scores indicating higher levels of anxiety.
Clinical Impairment Assessment (CIA)
时间窗: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up
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 responses 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 Fear Questionnaire (EDFQ)
时间窗: Baseline, Sessions 1-20, 3-Month-Follow-Up
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 indicates a higher severe impairment.
Eating Anxiety Questionnaire
时间窗: Baseline, Sessions 1-20, 3-Month-Follow-Up
The Eating Gain Anxiety Questionnaire is a 14-item self-report questionnaire that targets anxiety about eating fear foods. The scores are measured on a 0-100 scale, with the higher the score indicating more distress about eating fear foods, with the exception for question 2 which is reverse scored.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up
The Patient Health Questionnaire-9 is a 9-item self-report questionnaire that targets depressive symptoms. The scores range from 0-27, with higher scores indicating a higher level of depression.
Eating Disorder Examination - Self-Report Questionnaire Parent Version 1.5 (PEDE-Q)
时间窗: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up
Eating Disorder Examination - Self-Report Questionnaire Parent Version 1.5 (PEDE-Q) is a 29-item self-report questionnaire. It is intended to be completed by the parent of a child with an eating disorder targeting the parent's perspective of their child's eating disorder. It was designed to assess the range, frequency, and severity of behaviors associated with a diagnosis of an eating disorder. A global score is obtained by summing the four subscales scores (ranging from 0-6) and dividing the total by the number of subscales (4). The score of items are calculated and range from 0 to 6. The higher scores indicate greater perceived child's ED symptoms.
Parent vs Eating Disorder Scale (PVED)
时间窗: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up
The Parent vs Eating Disorder Scale (PVED) is a 7-item self-report questionnaire that examines parents' opinions on parent involvement in the treatment of their child's eating disorder. Higher scores indicate higher agreement with the statements, and lower scores indicate lower agreement with the statements. Scores range from 1 (strongly disagree) - 5 (strongly agree).
Percent of Expected Body Weight (EBW)
时间窗: Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up
We will measure the participants' weight using a wireless smart scale.
次要结局
- Treatment Acceptability Questionnaire(Baseline, Mid-Treatment, End-of-Treatment, 3-Month-Follow-Up)
- Recruitment(Through study completion, an average of 2 years)
- Retention(Through study completion, an average of 2 years)
- Engagement(Through study completion, an average of 2 years)
- Treatment Fidelity(Through study completion, an average of 2 years)
研究者
Jamal Essayli
Assistant Professor of Pediatrics and Psychiatry & Behavioral Health
Milton S. Hershey Medical Center