Institute of Psychology, Goethe-Universitaet Frankfurt, Varrentrappstr. 40-42, 60486, Frankfurt, Germany.
Institute for Clinical Psychology and Psychotherapy, Technische Universitaet Dresden, Dresden, Germany.
Trials. 2023 Mar 1;24(1):154. doi: 10.1186/s13063-023-07168-5.
There is growing evidence that Internet-based cognitive behavioral therapy (ICBT) is as effective as a stand-alone treatment and helps facilitating access to treatment. Given the complexity of the treatment, we argue that the effect of ICBT could be even greater if guided by a therapist, as this could increase treatment adherence. We modified an established and well-evaluated treatment approach and developed a mobile application for treating social anxiety disorder (SAD). In the present study, we compare the efficacy of app use alone (APP) with video-based, therapist-guided app use (TG-APP) and with a wait-list control group (WLC) in terms of symptom reduction, and various secondary outcomes such as increase in quality of life or decrease of general psychological distress.
METHODS/DESIGN: A within-between interaction design with randomization to one of three conditions will be used. In the APP condition, patients receive only the app without any additional contact with therapists, while in the TG-APP condition, therapists provide 8 sessions of video-based treatment in addition to using the app. The study will be conducted in two university outpatient treatment centers with reliably diagnosed SAD patients. The primary outcome will be defined as change in SAD symptoms, as measured by the Liebowitz Social Anxiety Scale (expert rating). Furthermore, a wide range of self-reports and clinician ratings for other symptoms (depression, general psychopathology) or quality of life will be used. A simulation-based power analysis for a 3 × 2 interaction effect (group × time) on the primary outcome in a linear mixed model resulted in a total sample size of N = 165.
The present study will be one of the first to examine the additional benefit of therapist-guided video sessions regarding the use of an app treating SAD. Study results are pivotal to future treatment application in SAD.
越来越多的证据表明，基于互联网的认知行为疗法（ICBT）与独立治疗一样有效，并有助于促进治疗的可及性。鉴于治疗的复杂性，如果由治疗师指导，ICBT 的效果可能会更大，因为这可以提高治疗的依从性。我们修改了一种已建立且经过良好评估的治疗方法，并为治疗社交焦虑症（SAD）开发了一款移动应用程序。在本研究中，我们比较了仅使用应用程序（APP）、基于视频的治疗师指导应用程序（TG-APP）和等待名单对照组（WLC）在症状减轻方面的疗效，以及生活质量提高或一般心理困扰减轻等各种次要结果。
方法/设计：采用随机分组的三向交互设计。在 APP 条件下，患者仅接收应用程序，而不与治疗师进行任何额外的接触，而在 TG-APP 条件下，治疗师在使用应用程序的同时提供 8 次基于视频的治疗。该研究将在两个具有可靠诊断的 SAD 患者的大学门诊治疗中心进行。主要结局将定义为 SAD 症状的变化，通过 Liebowitz 社交焦虑量表（专家评定）测量。此外，还将使用广泛的自我报告和临床医生评定，用于其他症状（抑郁、一般精神病理学）或生活质量。基于模拟的线性混合模型中主要结局的 3×2 交互效应（组×时间）的功效分析得出，总样本量 N = 165。
本研究将是第一个检查治疗师指导的视频会议对使用治疗 SAD 的应用程序的额外益处的研究之一。研究结果对于 SAD 的未来治疗应用至关重要。
