McAllister Jan, Gascoine Sally, Carroll Amy, Humby Kate, Kingston Mary, Shepstone Lee, Risebro Helen, Mackintosh Bundy, Thompson Tammy Davidson, Hodgekins Jo
School of Health Sciences, University of East Anglia, Research Park, Norwich, UK.
Sobell Department of Motor Neuroscience and Movement Disorders, University College London, London, UK.
BMJ Open. 2017 Oct 22;7(10):e015601. doi: 10.1136/bmjopen-2016-015601.
To determine the feasibility and acceptability of a computerised treatment for social anxiety disorder for adults who stutter including identification of recruitment, retention and completion rates, large cost drivers and selection of most appropriate outcome measure(s) to inform the design of a future definitive trial.
Two-group parallel design (treatment vs placebo), double-blinded feasibility study.
31 adults who stutter.
Attention training via an online probe detection task in which the stimuli were images of faces displaying neutral and disgusted expressions.
Psychological measures: Structured Clinical Interview Global Assessment of Functioning score; Liebowitz Social Anxiety Scale; Social Phobia and Anxiety Inventory; State-Trait Anxiety Inventory; Unhelpful Thoughts and Beliefs about Stuttering. Speech fluency: percent syllables stuttered. Economic evaluation: resource use questionnaire; EuroQol three-dimension questionnaire.Acceptability: Likert Scale questionnaire of experience of trial, acceptability of the intervention and randomisation procedure.
Feasibility of recruitment strategy was demonstrated. Participant feedback indicated that the intervention and definitive trial, including randomisation, would be acceptable to adults who stutter. Of the 31 participants who were randomised, 25 provided data at all three data collection points.
The feasibility study informed components of the intervention. Modifications to the design are needed before a definitive trial can be undertaken.
I SRCTN55065978; Post-results.
确定针对口吃成年人社交焦虑障碍的计算机化治疗的可行性和可接受性，包括确定招募、留存和完成率、主要成本驱动因素以及选择最合适的结局指标，以为未来确定性试验的设计提供信息。
两组平行设计（治疗组与安慰剂组），双盲可行性研究。
31名口吃成年人。
通过在线探测任务进行注意力训练，其中刺激物是显示中性和厌恶表情的面部图像。
心理测量指标：结构化临床访谈功能总体评定量表得分；利博维茨社交焦虑量表；社交恐惧症与焦虑量表；状态-特质焦虑量表；对口吃的无益想法和信念。言语流畅性：口吃音节百分比。经济评估：资源使用问卷；欧洲五维健康量表。可接受性：关于试验体验、干预措施可接受性和随机化程序的李克特量表问卷。
证明了招募策略的可行性。参与者反馈表明，干预措施和确定性试验，包括随机化，对口吃成年人是可接受的。在31名随机分组的参与者中，25人在所有三个数据收集点都提供了数据。
可行性研究为干预措施的组成部分提供了信息。在进行确定性试验之前，需要对设计进行修改。
ISRCTN55065978；结果后注册。
