School of Psychology and Clinical Language Sciences, University of Reading, Harry Pitt Building, Earley Gate, Reading, RG6 6AL, UK.
Departments of Experimental Psychology and Psychiatry, Anna, Watts Building, Oxford, OX2 6GG, UK.
Trials. 2019 Apr 25;20(1):240. doi: 10.1186/s13063-019-3295-6.
Anxiety disorders affect a quarter of the population during their lifetime, and typically emerge in childhood or adolescence. Anxiety disorders disrupt young people's social, emotional and academic development and in the absence of treatment, often follow a chronic course. Although effective treatments, such as Cognitive Behaviour Therapy (CBT), exist, only a small proportion of adolescents with anxiety disorders who need treatment receive them. Barriers to treatment provision include the fact that CBT typically requires 14-16 sessions by a highly qualified therapist and services are stretched - resulting in lengthy waiting lists and limited access to treatment. This highlights the importance of developing new ways of providing effective treatments for adolescent anxiety disorders. This study aims to assess the feasibility of a future, large-scale trial. This will give a clear indication of the likely success of running a randomised controlled trial to compare a new, brief cognitive therapy treatment to an existing CBT group therapy for adolescents with anxiety disorders.
METHODS/DESIGN: The study will examine whether a definitive trial can be conducted on the basis of a feasibility RCT using a number of well-defined criteria. The feasibility RCT is a single-centre, randomised control trial. Forty-eight Young people (age 11-17.5 years) attending a university research clinic, who meet the diagnostic criteria for a DSM-5 anxiety disorder, will be randomly allocated to receive either (1) Adolescent Cognitive Therapy for Anxiety (ACTA), which involves six 60-90-min sessions and a booster session or (2) group CBT, which involves eight 2-h sessions and a booster session. As part of the feasibility indicators, patient outcomes, expectations and experiences, as well as health economic factors, will be assessed before, at the end of treatment and at a 3-month follow-up.
The successful delivery of a future, definitive trial has the potential to bring direct benefits to young people and their families, adolescent mental health service providers, as well as benefits to adult mental health services and society more broadly by disrupting the negative trajectory commonly associated with adolescent anxiety disorders.
ISRCTN, ID: ISRCTN86123204 . Retrospectively registered on 23 November 2017.
焦虑障碍在人的一生中有四分之一的概率发生，通常在儿童或青少年时期出现。焦虑障碍会破坏年轻人的社交、情感和学业发展，而且如果不加以治疗，通常会呈现慢性病程。尽管存在有效的治疗方法，如认知行为疗法（CBT），但只有一小部分需要治疗的青少年焦虑障碍患者接受了治疗。治疗提供的障碍包括以下事实：CBT 通常需要由高度合格的治疗师进行 14-16 次治疗，而服务范围有限，导致长时间的等待名单和有限的治疗机会。这突出了开发新方法为青少年焦虑障碍提供有效治疗的重要性。本研究旨在评估未来大规模试验的可行性。这将清楚地表明，对于比较新的简短认知治疗与现有的青少年焦虑障碍群体 CBT 治疗的随机对照试验，进行随机对照试验的可能性。
方法/设计：该研究将根据使用多项明确定义标准的可行性 RCT 来检查是否可以进行确定性试验。该可行性 RCT 是一项单中心、随机对照试验。48 名年龄在 11-17.5 岁之间、符合 DSM-5 焦虑障碍诊断标准的年轻人将被随机分配接受以下治疗之一：（1）青少年认知治疗焦虑症（ACTA），共涉及 6 次 60-90 分钟的治疗和一次强化治疗，或（2）群体 CBT，共涉及 8 次 2 小时的治疗和一次强化治疗。作为可行性指标的一部分，将在治疗前、治疗结束时和 3 个月随访时评估患者的结局、期望和体验以及健康经济学因素。
未来确定性试验的成功实施有可能为年轻人及其家人、青少年心理健康服务提供者带来直接利益，也为成人心理健康服务和更广泛的社会带来利益，从而打破与青少年焦虑障碍相关的负面轨迹。
ISRCTN，ID：ISRCTN86123204。于 2017 年 11 月 23 日进行回顾性注册。
