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临床试验/NCT02307097
NCT02307097已完成不适用

Randomised Controlled Trial of Cognitive-Behavioural Bibliotherapy (CBB) for Social Anxiety Disorder as a Prelude to High-Intensity Cognitive-Behavioural Therapy (CBT) in a Local IAPT Service.

Solent NHS Trust2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
2
主要终点
The Social Participation & Satisfaction Questionnaire (SPSQ; Alden & Taylor, 2011)

研究概览

简要总结

The efficacy of high-intensity Cognitive-Behavioural Therapy (CBT) for social anxiety disorder is well established (Mayo-Wilson et al., 2014) and it is recommended by the National Institute of Health and Clinical Excellence (NICE) as the first-line psychological intervention for social anxiety disorder. The treatment aims to modify several maintenance factors (e.g., self-focused attention) that are specified in cognitive models of social anxiety disorder (e.g., Clark & Wells, 1995).

Cognitive-behavioural self-help treatments for social anxiety disorder have been developed to overcome various accessibility issues (e.g., long wait-lists, and the patient's need to avoid social situations, etc) associated with high-intensity CBT (Abramowitz et al., 2009; Carlbring et al., 2007) but a recent network meta-analysis (Mayo-Wilson et al., 2014) identified the former as less cost-effective than the later and thus, they are not recommended as standalone treatments.

However, the potential benefit of cognitive-behavioural self-help treatments for social anxiety disorder within a stepped-care recovery model as a prelude to high-intensity CBT has not been formally evaluated.

The aim of this study is to evaluate a seminal Cognitive-Behavioural Bibliotherapy* (CBB; "pure self-help" book) - 'Overcoming Social Anxiety & Shyness' (Butler, 2009) - for patients with social anxiety disorder while on the wait-list for high-intensity CBT within an Improving Access to Psychological Therapies (IAPT) service, and to determine if some patients recover from CBB alone or whether there may be a reduction in the average number of high-intensity CBT sessions for those patients who subsequently require further treatment.

The study is funded by Constable & Robinson, Kellogg College (University of Oxford) and Talking Change (Solent NHS Trust).

* The Reading Well Books on Prescription scheme with funding from the Arts Council England enables general practitioners (GPs) and mental health professionals to prescribe seminal CBBs for patients with mood and anxiety disorders. The books are accessed free of charge via local libraries. The scheme works within NICE guidelines and it is support by the Royal Colleges of GPs, Nursing and Psychiatrists, the British Association for Behavioural and Cognitive Psychotherapies and the Department of Health through its IAPT programme.

详细描述

P A R T I C I P A N T S

Patients will be recruited within an Improving Access to Psychological Therapies (IAPT) service: 'Talking Change' (Portsmouth). Advertisement for the study will be distributed locally, through social media and via the 'Talking Change' Internet website.

It is generally accepted that social anxiety disorder is a chronic condition and significant change in the wait-list does not occur. Hence, because the study aims to explore predicators of treatment response, a priori power analyses determined that approximately 114 patients randomly assigned for twelve-weeks at a ratio of 2:1 would provide sufficient power for statistical analyses; seventy-six and thirty-eight patients in the Cognitive-Behavioural Bibliotherapy (CBB) and wait-list control (WAIT) group, respectively.

Randomisation will be conducted by someone unassociated with the study using sealed envelopes.

M E A S U R E S

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

WAIT

Active Comparator

干预措施: WAIT (Other)

CBB

Experimental

干预措施: Cognitive-Behavioural Bibliotherapy (Procedure)

CBT

Experimental

干预措施: Cognitive-Behavioural Therapy (Procedure)

结局指标

主要结局

The Social Participation & Satisfaction Questionnaire (SPSQ; Alden & Taylor, 2011)

时间窗: 2 minutes

The SPSQ will assess the degree by which the participant is participating is social activity, and relationship satisfaction.

IAPT Standard Minimum Data Set (MDS)

时间窗: 2 minutes

The brief versions of the Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, \& Williams, 2001) and the Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kroenke, Williams, \& Löwe, 2006) will assess mood and generalised anxiety, respectively. The Work and Social Adjustment Scale (WSAS; Marks, 1986) will assess functional impairment attributable to an identified problem. The Phobia Scales is a non-validated phobia screener of social phobia, panic disorder/agoraphobia, and specific phobia avoidance.

The Social Phobia Inventory (SPIN; Connor, 2000)

时间窗: 2 minutes

The SPIN will assess the main spectrum of social anxiety disorder such as fear, avoidance, and physiological symptoms.

次要结局

  • Anticipatory Processing Questionnaire (APQ; Vassilopoulos, 2004) and Post-Event Processing Questionnaire-Revised (PEPQ-R; McEvoy & Kingsep, 2006)(2 minutes)
  • Social Behaviour Questionnaire (SBQ; Clark et al., 2006)(2 minutes)
  • Liebowitz Social Anxiety Scale (LSAS-SR; Baker, Heinrich, Kim, & Hofmann, 2002; Liebowitz, 1987)(2 minutes)
  • Self-Focused Attention Scale (SFA; Bögels, Alberts, & de Jong, 1996)(2 minutes)
  • Social Phobia Cognitions Questionnaire (SPC; Clark et al., 2006)(2 minutes)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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