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.

PAR-21-130：临床试验，以测试治疗，预防， 服务干预。神经性厌食症（Anorexia Nervosa，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 持久的课程青少年AN的一线治疗是家庭治疗（FBT），但不是 对许多患者来说都是可行的。一种有效的策略用于其他饮食失调，以解决障碍， 缩放有效治疗是有效治疗的引导自助（GSH）版本。我们开发了， 在病例系列和试点研究中完善和测试GSH-FBT。多中心随机可行性的结果 比较GSH-FBT和FBT-V的研究发现，对于健康状况良好的家庭来说，这两种治疗方法都同样可以接受。 招聘率、自然减员率低、评估完成率高，交付安全， 在饮食相关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 具有更高效率的结果（例如，体重和认知改善的比例较大 治疗时间），比FBT-V减少约75%的治疗时间。 比较有效性研究的目的是证实GSH-FBT的临床改善， 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， 有机会利用和扩大对青少年AN的有效治疗，促进增加获得和 改善这些患者的预后。我们还将探讨治疗师对GSH-FBT的态度。进行是次 研究200名DSM-5 AN青少年及其家庭将随机接受GSH-FBT或FBT-V， 两个治疗地点（斯坦福大学儿童医院饮食失调诊所和安大略省网络， 政府资助的饮食失调症专门治疗服务）。主要结果将是临床 效率（体重和饮食相关的扭曲认知的变化与治疗时间的比率）。父母的自我- 疗效将作为治疗效果的潜在介导因素进行评估。家庭结构和饮食的严重性 相关的痴迷将被审查为版主。将从第1-4阶段收集权重以尽早评估 体重增加作为治疗结束（EOT）时体重缓解的预测因素。治疗师对以下问题的看法 GSH-FBT实施情况将通过BL和EOT时的定量测量以及个人收集 半结构化定性访谈。主要和次要结局均将根据 意图对待原则。