阿斯伯格综合征与焦虑障碍共病（PASSA）治疗试验：一项关于团体认知行为治疗的先导、多中心、单盲、随机交叉试验的研究方案。
Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy.
机构信息
Department of Psychological Sciences, Norwich Medical School, University of East Anglia and Broadland Clinic, Hertfordshire Partnership NHS Foundation Trust, Norwich, UK.
出版信息
BMJ Open. 2013 Jul 30;3(7):e003449. doi: 10.1136/bmjopen-2013-003449.
INTRODUCTION
A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious.
METHODS AND ANALYSIS
This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money.
ETHICS AND DISSEMINATION
The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community.
TRIAL REGISTRATION
ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370.
介绍
多项研究表明，患有阿斯伯格综合征（AS）和高功能自闭症（HFA）的儿童、青少年和成年人存在明显的焦虑问题。认知行为疗法（CBT）是一种针对各种临床人群焦虑症的有效治疗方法。人们越来越感兴趣地探索 CBT 对有心理健康问题的 AS 人群的有效性，但目前尚无针对 AS 或 HFA 成人的已知临床试验。针对 AS 儿童的研究报告取得了一些成功。本研究旨在检验针对 AS 人群中临床显著焦虑的改良团体 CBT 是否有效。
方法与分析
本研究是一项随机、单盲交叉试验。将招募至少 36 名参与者，并随机分配到治疗组或等待名单对照组。在治疗期间，个体将接受 3 次个体 CBT，然后接受 21 次团体 CBT。主要结局指标侧重于焦虑。次要结局指标侧重于日常社交和精神功能、焦虑和恐惧的额外测量、抑郁、健康相关生活质量和治疗成本。研究人员将在分组前和分组后以及随访时进行评估，研究人员对分组分配不知情。该试验旨在确定是否可以调整和使用心理治疗来成功治疗 AS 患者所经历的焦虑，此外，我们旨在确定这种干预是否物有所值。
伦理与传播
该试验获得了国家卫生服务（NHS）伦理委员会的有利伦理意见。所有参与者均提供了书面知情同意书。研究结果将与所有试验参与者以及公众和科学界分享。
试验注册
ISRCTN30265294（DOI：10.1186/ISRCTN30265294），UKCRN 8370。
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