Confirming the Effectiveness and Efficiency of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa

确认在线指导自助家庭治疗青少年神经性厌食症的有效性和效率

• 批准号: 10505414
• 负责人: JAMES D LOCK
• 金额: $ 66.97万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10505414
• 关键词: Address; Adolescent; Adoption; Anorexia Nervosa; Attitude; Behavior; Blinded; Body Weight; Case Series; Child; Clinic; Clinical; Clinical Trials; Cognition; DSM-V; Data; Disease remission; Divorce; Dose; Early treatment; Eating; Eating Disorders; Effectiveness; Family; Family Study; Feasibility Studies; Funding; Health Services Accessibility; Health system; Healthcare Systems; Incidence; Individual; Intention; Intervention; Interview; Measures; Mediating; Mediator of activation protein; Morbidity - disease rate; Obsession; Ontario; Outcome; Parents; Patient-Focused Outcomes; Patients; Pediatric Hospitals; Persons; Pilot Projects; Randomized; Reading; Recovery; Resistance; Self Efficacy; Severities; Single Parent; Structure; Testing; Time; Treatment Effectiveness; Treatment outcome; Video Recording; Videoconferencing; Weight; Weight Gain; Youth; base; comparative effectiveness; comparative effectiveness study; cost; effective therapy; effectiveness testing; efficacious treatment; empowered; evidence base; experience; family structure; flexibility; follow-up; hybrid type 1 design; implementation facilitators; improved; improved outcome; mortality; preventive intervention; primary outcome; reconstitution; recruit; response; secondary outcome; self help; service intervention; severe mental illness; treatment comparison; treatment effect; treatment program; treatment services; treatment site

The application responds to PAR-21-130: Clinical Trials to Test the Effectiveness of Treatment, Prevention, and Services Interventions. With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity and cost but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT), but is not available to many patients. An effective strategy used with other eating disorders to address impediments to scaling effective treatments is guided self-help (GSH) versions of efficacious treatments. We developed, refined, and tested GSH-FBT in case series and pilot studies. Results of a multisite randomized feasibility study comparing GSH-FBT to FBT-V found that both treatments were similarly acceptable to families with good recruitment rates, low attrition rates, high completion rates of assessments, and were safe to deliver while achieving similar improvements in eating related cognitions and weight. However, GSH-FBT achieved these outcomes with greater efficiency (e.g., larger ratio of improvement in weight and cognitions to therapist treatment time) by utilizing approximately 75% less therapist time than FBT-V. 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. If this outcome is confirmed, it will lead to an increased opportunity to utilize and scale an effective treatment for adolescent AN, promote increased access and improve outcomes for these patients. We will also explore therapist attitudes toward GSH-FBT. To conduct this study 200 adolescents with DSM-5 AN and their families will be randomized to either GSH-FBT or FBT-V in two treatment sites (Stanford Children’s Hospital Eating Disorder Clinic and the Ontario Provincial Network of Ministry-funded Specialized Treatment Services for Eating Disorders). The main outcome will be clinical efficiency (the ratio of change in weight and eating related distorted cognitions to therapist time). Parental self- efficacy will be assessed as a potential mediator of treatment effect. Family structure and severity of eating related obsessions will be examined as moderators. Weights will be collected from session 1-4 to assess early weight gain as a predictor of weight remission at the end of treatment (EOT). Data on therapists’ views of GSH-FBT implementation will be collected by quantitative measures at BL and EOT, as well as by individual semi-structured qualitative interviews. Both primary and secondary outcomes will be analyzed in line with the intention to treat principle.

该应用程序响应 PAR-21-130：测试治疗、预防、 神经性厌食症 (AN) 的发病率约为 1%，是一种严重的精神疾病。 与高死亡率、发病率和费用相关的疾病，但一旦采取措施后就会变得高度耐药 患有 AN 的青少年的一线治疗是基于家庭的治疗 (FBT)，但事实并非如此。 对于许多患者来说，这是一种用于解决其他饮食失调障碍的有效策略。 缩放有效治疗是我们开发的有效治疗的引导自助（GSH）版本。 在病例系列和试点研究中完善并测试了 GSH-FBT 的多中心随机可行性结果。 比较 GSH-FBT 和 FBT-V 的研究发现，这两种治疗方法同样可以被家庭状况良好的家庭所接受。 招聘率高，人员流失率低，评估完成率高，并且可以安全地交付 然而，GSH-FBT 在饮食相关认知和体重方面也取得了类似的改善。 更有效的结果（例如，治疗师的体重和认知改善比例更大） 治疗时间）比 FBT-V 减少约 75% 的治疗时间 这是该提议的主要目标。 比较有效性研究的目的是确认 GSH-FBT 的临床改善可以通过更大的 在普遍的临床环境中，效率高于 FBT-V 如果这一结果得到证实，它将导致效率的提高。 有机会利用和扩大青少年 AN 的有效治疗方法，促进增加获取和 我们还将探讨治疗师对 GSH-FBT 的态度。 研究将 200 名患有 DSM-5 AN 的青少年及其家人随机分配至 GSH-FBT 或 FBT-V 组 两个治疗点（斯坦福儿童医院饮食失调诊所和安大略省网络 部资助的饮食失调专门治疗服务）主要成果将是临床。 效率（体重变化和饮食相关的扭曲认知与治疗师时间的比率）。 疗效将作为治疗效果的潜在中介因素进行评估。 相关的困扰将作为主持人进行检查，将从第 1-4 节中收集权重以进行早期评估。 体重增加作为治疗结束时体重缓解的预测指标 (EOT) 治疗师观点的数据。 GSH-FBT 将通过 BL 和 EOT 的定量措施以及个人收集实施情况 半结构化定性访谈将根据以下内容进行分析。 意向对待原则。