Data Center - Family Therapy and Flouxetine in Treatment of Anorexia Nervosa

数据中心 - 家庭疗法和氟西汀治疗神经性厌食症

• 批准号: 7255745
• 负责人: WILLIAM Stewart AGRAS
• 金额: $ 18.57万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7255745
• 关键词: Adolescence; Adolescent; Adult; Anorexia Nervosa; Anxiety; Behavior; Behavioral; Binge Eating; Blood; Bulimia; Child; Childhood; Chronic; Clinical Trials; Clinics and Hospitals; Communities; Condition; Controlled Study; DSM-IV; Data; Data Coordinating Center; Death Rate; Development; Disease; Divorce; Doctor of Philosophy; Early treatment; Eating Behavior; Eating Disorders; Effectiveness; Evaluation; Family; Family dynamics; Family psychotherapy; Fluoxetine; Future; Genetic; Goals; Health Care Costs; Health system; Individual; Institution; Intervention; Label; Lead; Life; Maintenance; Mediator of activation protein; Mental Health; Monitor; Moods; Morbidity - disease rate; Neurotransmitters; Numbers; Obsessive-Compulsive Disorder; Outcome; Outpatients; Parents; Participant; Pathway interactions; Patients; Pharmaceutical Preparations; Phase; Phenotype; Placebos; Prevalence; Principal Investigator; Procedures; Psychopathology; Public Health; Purpose; Qualifying; Randomized; Randomized Controlled Trials; Rate; Recovery; Relative (related person); Research; Research Personnel; Research Training; Resources; Running; Series; Serotonin; Single Parent; Site; Social Phobia; Staging; Symptoms; System; Testing; Therapeutic; Thinking; Time; Treatment Protocols; Treatment outcome; Universities; Washington; Week; Weight; Work; aged; base; clinical research site; compliance behavior; cost; disability; experience; family structure; feeding; follow-up; human subject; improved; innovation; investigator training; mortality; nutrition; placebo controlled study; prevent; programs; psychologic; psychosocial; response; treatment site; treatment trial

DESCRIPTION (provided by applicant): The long-term objective of this proposal is to enhance the treatment and outcome of anorexia nervosa (AN) and to develop a network of research and training centers to support innovative research in AN. Research on the treatment of AN has lagged that of other conditions, even other eating disorders such as bulimia nervosa, hence it is important to test potentially effective treatments in a large scale study so as to provide a baseline for future studies. The focus of this proposal is on adolescent AN. Successful early treatment is likely to reduce the prevalence of chronic AN with its high rates of morbidity and mortality and high health care costs. The most promising treatment for adolescent AN is a specific form of family therapy, (the Maudsley approach) called here, behavioral family therapy (BFT). This treatment is focused on the disordered eating behavior that characterizes AN and enables parents to refeed their child. Additionally, there is preliminary evidence that fluoxetine may be useful in reducing comorbid psychopathology and enhancing maintenance in AN. However, there has been no placebo controlled study of fluoxetine in adolescent AN. Moreover, although there have been several small-scale studies of BFT there has been no controlled comparison with another form of family therapy. Hence, we propose to use systems family therapy (SFT) which has been developed and manualized to represent the type of family therapy practiced in the community. We propose to randomly allocate 240 adolescents aged 12-18 years with AN and their families to one of 4 groups: BFT + placebo; BFT + fluoxetine; SFT + placebo; and SFT + fluoxetine. Medication will be continued for 6-months beyond the end of family therapy to assess medication effects on the maintenance of therapeutic gains. Treatment and assessment will be carried out at 6 clinical sites with 40 subjects per site with separate data and coordinating centers. The treatment sites will follow common assessment and treatment protocols with detailed monitoring of recruitment, treatment, assessment and human subjects procedures by the coordinating center. The results of this study should provide guidance to clinicians concerning optimal treatment approaches for adolescent AN. From the public health perspective, development of effective treatments for adolescents will reduce the morbidity, mortality, and high costs associated with chronic AN.

描述（由申请人提供）：本提案的长期目标是加强神经性厌食症（AN）的治疗和结局，并建立一个研究和培训中心网络，以支持AN的创新研究。对AN治疗的研究已经落后于其他疾病，甚至其他饮食失调，如神经性贪食症，因此在大规模研究中测试潜在的有效治疗方法是很重要的，以便为未来的研究提供基线。这项建议的重点是青少年AN。成功的早期治疗可能会降低慢性AN的患病率，其高发病率和死亡率以及高医疗保健费用。青少年AN最有希望的治疗方法是一种特殊形式的家庭治疗（Maudsley方法），在这里称为行为家庭治疗（BFT）。这种治疗的重点是AN的特征饮食行为紊乱，使父母能够重新喂养他们的孩子。此外，有初步证据表明，氟西汀可能有助于减少AN的共病精神病理学和增强维持。然而，尚无氟西汀治疗青少年AN的安慰剂对照研究。此外，虽然有几个小规模的研究BFT一直没有对照比较与另一种形式的家庭治疗。因此，我们建议使用系统的家庭治疗（SFT）已开发和手册，以代表在社区中实行的家庭治疗的类型。我们建议将240名12-18岁的AN青少年及其家人随机分配到4组中的一组：BFT +安慰剂; BFT +氟西汀; SFT +安慰剂; SFT +氟西汀。在家庭治疗结束后，将继续用药6个月，以评估药物对维持治疗效果的影响。治疗和评估将在6家临床研究中心进行，每家研究中心40例受试者，数据和协调中心独立。治疗中心将遵循共同的评估和治疗方案，并由协调中心对招募、治疗、评估和人类受试者程序进行详细监测。这项研究的结果应提供指导临床医生有关青少年AN的最佳治疗方法。从公共卫生的角度来看，发展有效的治疗青少年将降低发病率，死亡率，并与慢性AN相关的高成本。