Timko C Alix, Goulazian Tiffanie J, Fitzpatrick Kathleen Kara, Rodriguez Daniel
1Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104 USA.
2Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA 19104 USA.
Pilot Feasibility Stud. 2018 Jun 25;4:87. doi: 10.1186/s40814-018-0277-5. eCollection 2018.
Anorexia nervosa (AN) is a severe psychiatric condition characterized by low body weight, fear of weight gain/becoming fat and/or behavior that interferes with weight gain, and body disturbance. Though there have been recent advances in the treatment of AN, there continues to be an urgent need to increase treatment options. Cognitive remediation therapy (CRT) has been successfully used as an adjunctive treatment for individuals with AN. In this study, we pilot the use of CRT plus an innovative parent involvement component as a pre-treatment intervention on a medical unit. We hypothesize that adding CRT with parent involvement to a standard hospital stay is feasible, acceptable by patients and staff, and may improve treatment outcomes post-hospitalization.
METHODS/DESIGN: This is a pilot randomized controlled trial with three arms. Participants are adolescents aged 12-18 with AN; 60 participants will be included. They are randomized into one of three groups: treatment as usual (TAU, standard care at Children's Hospital of Philadelphia), CRT + contact control (known as "Family Fun Time"), and CRT + Teach the Parent. Intervention will occur on an inpatient basis. Follow-up will be outpatient and will continue until 6 months post-discharge. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study, and group differences will be evaluated at 4 weeks, 3 months, and 6 months post-discharge. The study will take place at The Children's Hospital of Philadelphia.
This pilot randomized controlled trial will inform feasibility of the integration of a pre-treatment intervention into a medical hospital stay for AN. We will assess recruitment procedures, treatment administration, and participant retention. Finally, a comprehensive assessment battery will be evaluated. Secondary goals are to conduct a preliminary evaluation of whether or not CRT with parent involvement increases rate of weight gain and treatment engagement and decreases parental accommodation of symptoms post-discharge. If successful, this pilot study will inform a larger controlled trial fully powered to examine the secondary goals.
ClinicalTrials.gov Identifier NCT02883413.
神经性厌食症（AN）是一种严重的精神疾病，其特征包括体重过低、害怕体重增加/变胖和/或干扰体重增加的行为以及身体形象紊乱。尽管近年来AN的治疗取得了进展，但仍迫切需要增加治疗选择。认知康复疗法（CRT）已成功用作AN患者的辅助治疗方法。在本研究中，我们试行将CRT与创新的家长参与部分相结合，作为对一个医疗单元的预处理干预措施。我们假设，在标准住院期间增加有家长参与的CRT是可行的，患者和工作人员均可接受，并且可能改善出院后的治疗效果。
方法/设计：这是一项有三个组的试点随机对照试验。参与者为12至18岁的AN青少年；将纳入60名参与者。他们被随机分为三组之一：常规治疗（TAU，费城儿童医院的标准护理）、CRT+接触控制（称为“家庭欢乐时光”）和CRT+教导家长。干预将在住院基础上进行。随访将在门诊进行，并将持续至出院后6个月。在整个研究过程中收集社会心理、神经认知和行为指标，并在出院后4周、3个月和6个月评估组间差异。该研究将在费城儿童医院进行。
这项试点随机对照试验将为将预处理干预措施纳入AN患者的住院治疗的可行性提供信息。我们将评估招募程序、治疗实施和参与者留存情况。最后，将评估一套综合评估指标。次要目标是对有家长参与的CRT是否能提高体重增加率和治疗参与度以及降低出院后家长对症状的迁就程度进行初步评估。如果成功，这项试点研究将为一项更大规模的对照试验提供信息，该试验有足够的效力来检验次要目标。
ClinicalTrials.gov标识符NCT02883413。
