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: 10707470
• 负责人: JAMES D LOCK
• 金额: $ 65.38万
• 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/10707470
• 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; Morbidity - disease rate; Obsession; Ontario; Outcome; Parents; Patient-Focused Outcomes; Patients; Pediatric Hospitals; Persons; Pilot Projects; Randomized; Recovery; Resistance; Self Efficacy; Severities; Single Parent; Site; Structure; Teleconferences; Testing; Time; Treatment Effectiveness; Video Recording; Videoconferencing; Weight; Weight Gain; Youth; comparative effectiveness study; cost; effective therapy; effectiveness testing; efficacious treatment; empowerment; 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; systemic barrier; 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：临床试验以测试治疗、预防、 和服务干预。神经性厌食症(AN)是一种严重的精神疾病，发病率约为1%。 与高死亡率、发病率和成本相关的疾病，但一旦服用了 久久为功。青少年AN的一线治疗是基于家庭的治疗(FBT)，但不是 可供许多患者使用。与其他饮食失调症一起使用的有效策略，以解决阻碍 扩展有效治疗是有效治疗的引导自助(GSH)版本。我们开发了， 在案例系列和试点研究中提炼和测试了GSH-FBT。多点随机可行性研究结果 比较GSH-FBT和FBT-V的研究发现，这两种治疗方法对于有良好表现的家庭来说都是同样可以接受的 征聘比率低，人员流失率低，评估完成率高，可安全交付 在与饮食相关的认知和体重方面也取得了类似的改善。然而，GSH-FBT实现了这些目标 效率更高的结果(例如，与治疗师在体重和认知方面的改善比率更大 治疗时间)，使用的治疗时间比FBT-V少约75%。这项提议的主要目的是 比较有效性研究是为了证实GSH-FBT的临床改善是通过更大的 在可推广的临床环境中比FBT-V更有效。如果这一结果得到证实，它将导致 利用和推广青少年AN有效治疗的机会，促进更多的机会和 改善这些患者的预后。我们还将探讨治疗师对GSH-FBT的态度。进行这项工作 研究200名患有DSM-5 AN的青少年及其家人将被随机分为GSH-FBT组或FBT-V组 两个治疗站点(斯坦福儿童医院进食障碍诊所和安大略省网络 该部资助的饮食障碍专门治疗服务)。主要结果将是临床上的 有效率(体重变化和饮食相关的扭曲认知与治疗师时间的比率)。父母的自我- 疗效将被评估为治疗效果的潜在调解人。家庭结构与进食严重程度 相关的痴迷将作为主持人进行审查。将收集第1-4节课的权重，以便及早评估 体重增加作为治疗结束时体重减轻的预测指标(EOT)。治疗师对以下问题看法的数据 GSH-FBT的实施将通过在BL和EOT的量化措施以及个人进行收集 半结构化定性访谈。主要结果和次要结果都将根据 意向治疗原则。