一项针对大学生社交焦虑障碍的无指导、基于互联网的自助干预措施的疗效和成本效益的随机对照试验方案。
Efficacy and cost-effectiveness of an unguided, internet-based self-help intervention for social anxiety disorder in university students: protocol of a randomized controlled trial.
机构信息
Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Nägelsbachstrasse 25a, 91052, Erlangen, Germany.
Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.
出版信息
BMC Psychiatry. 2019 Jun 25;19(1):197. doi: 10.1186/s12888-019-2125-4.
BACKGROUND
Social anxiety disorder (SAD) is highly prevalent among university students, but the majority of affected students remain untreated. Internet- and mobile-based self-help interventions (IMIs) may be a promising strategy to address this unmet need. This study aims to investigate the efficacy and cost-effectiveness of an unguided internet-based treatment for SAD among university students. The intervention is optimized for the treatment of university students and includes one module targeting fear of positive evaluations that is a neglected aspect of SAD treatment.
METHODS
The study is a two arm randomized controlled trial in which 200 university students with a primary diagnosis of SAD will be assigned randomly to either a wait-list control group (WLC) or the intervention group (IG). The intervention consists of 9 sessions of an internet-based cognitive-behavioral treatment, which also includes a module on fear of positive evaluation (FPE). Guidance is delivered only on the basis of standardized automatic messages, consisting of positive reinforcements for session completion, reminders, and motivational messages in response to non-adherence. All participants will additionally have full access to treatment as usual. Diagnostic status will be assessed through Structured Clinical Interviews for DSM Disorders (SCID). Assessments will be completed at baseline, 10 weeks and 6-month follow-up. The primary outcome will be SAD symptoms at post-treatment, assessed via the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS). Secondary outcomes will include diagnostic status, depression, quality of life and fear of positive evaluation. Cost-effectiveness and cost-utility analyses will be evaluated from a societal and health provider perspective.
DISCUSSION
Results of this study will contribute to growing evidence for the efficacy and cost-effectiveness of unguided IMIs for the treatment of SAD in university students. Consequently, this trial may provide valuable information for policy makers and clinicians regarding the allocation of limited treatment resources to such interventions.
TRIAL REGISTRATION
DRKS00011424 (German Clinical Trials Register (DRKS)) Registered 14/12/2016.
背景
社交焦虑障碍（SAD）在大学生中患病率很高，但大多数受影响的学生仍未得到治疗。基于互联网和移动的自助干预（IMI）可能是满足这一未满足需求的有前途的策略。本研究旨在调查针对大学生社交焦虑障碍的非指导性基于互联网的治疗的疗效和成本效益。该干预措施针对大学生进行了优化，包括一个针对积极评价恐惧的模块，这是社交焦虑障碍治疗中被忽视的一个方面。
方法
这是一项两臂随机对照试验，将 200 名患有社交焦虑障碍主要诊断的大学生随机分配到等待名单对照组（WLC）或干预组（IG）。干预包括 9 节基于互联网的认知行为治疗，其中还包括一个关于积极评价恐惧（FPE）的模块。指导仅基于标准化的自动消息提供，这些消息包括对完成课程的积极强化、提醒以及对不遵守的动机性消息。所有参与者还将完全可以获得常规治疗。诊断状态将通过 DSM 障碍的结构化临床访谈（SCID）进行评估。评估将在基线、10 周和 6 个月随访时进行。主要结局将是治疗后的 SAD 症状，通过社交恐惧症量表（SPS）和社交互动焦虑量表（SIAS）进行评估。次要结局将包括诊断状态、抑郁、生活质量和积极评价恐惧。将从社会和卫生提供者的角度评估成本效益和成本效用分析。
讨论
本研究的结果将有助于为大学生社交焦虑障碍的非指导性 IMI 治疗的疗效和成本效益提供更多证据。因此，该试验可能为政策制定者和临床医生提供有关此类干预措施分配有限治疗资源的宝贵信息。
试验注册
DRKS00011424（德国临床试验注册处（DRKS））于 2016 年 12 月 14 日注册。
Zotero 插件