Confirming the Effectiveness and Efficiency of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Ratio of therapist hours to %EBW change
研究概览
简要总结
With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are 12-18 years of age
- •Participants live with a family (some families may contain only one parent)
- •Family members fluently speak and read English and have access to a computer with internet
- •Participants meet DSM-5 criteria for AN (both subtypes)
- •EBW above 75%
- •Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine
- •Participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study.
- •Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.
排除标准
- •Current psychotic illness or intellectual disability or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous FBT; and inability of the participant and/or family to speak and understand English.
研究组 & 干预措施
FBT via Videoconferencing (FBT-V)
15 60-minute sessions of 3-phase manualized FBT modified for videoconferencing will be delivered to participants randomized to this treatment by therapists trained in FBT. The first phase encourages parental management of weight restoration (approximately 8 weekly sessions); the second phase promotes a developmentally appropriate transition back to adolescent management of weight restoration and maintenance under parental supervision (approximately 4 bi-weekly sessions), and the third phase focuses on adolescent development (approximately 3 monthly sessions). Each session consists of 10 minutes with the adolescent individually to discuss progress and the adolescent's perspective on treatment, followed by 50 minutes with the entire family.
干预措施: FBT via Videoconferencing (Behavioral)
Online Guided Self-Help-Family-based Treatment (GSH-FBT)
GSH-FBT consists of 10 20-minute parent-only sessions over 9 months. The guidance portion is manualized and will be delivered by a clinician familiar with both the online modules and FBT, who acts as a "coach." Sessions follow an online curriculum containing a total of 65 short videos. Each lecture series is comprised of a written introduction orienting the viewer to the videos, 5-9 short videos (< 7 minutes each), and assigned reading from the parent education manual, Help Your Teenager Beat an Eating Disorder. In line with GSH approaches, coaches direct parents to watch or re-watch specific videos contained in the online platform related to their questions.
干预措施: Online Guided Self-Help-Family-based Treatment (Behavioral)
结局指标
主要结局
Ratio of therapist hours to %EBW change
时间窗: Assessed from baseline through end of treatment (EOT)
The investigators will compare GSH-FBT and FBT-V groups at EOT in terms of the change in %EBW from baseline divided by total therapist time utilized. Estimated Body Weight (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents. Total therapist time utilized will be collected based on video records of actual sessions spent with participants.
次要结局
- Beck Depression Inventory (BDI)(These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points (BL, 3 months within treatment, EOT, 6 and 12-month follow-up))
- Beck Anxiety Inventory (BAI)(Baseline, sessions 2, 4, 6, 8, and EOT)
- Eating Disorder Examination (EDE)(Baseline (before beginning treatment); 3 months within treatment; 9 months (EOT); and at 6- and 12-month follow-up)
研究者
James Dale Lock
Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents
Stanford University