PRIVATE - Preference Research: Investigating Variations of Anonymity, Transparency, and Efficacy in Digital Health Applications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 2
- 主要终点
- Social Anxiety Symptoms
研究概览
简要总结
Social Anxiety Disorder (SAD) is one of the most widespread mental illnesses and it has previously been shown that online therapy and online self-help tools such as the one investigated in this study can be successful in reducing not only symptoms of SAD but also symptoms of depression and increase the quality of life of participants. A substantial concern with digital health intervention tools is data security and privacy as many such tools have been found to be unsafe and easy targets for hacker attacks, potentially endangering personal (health) data of the users.
For this research project, an internet-based program targeting social anxiety has been developed that can be used completely anonymously (i.e., without collecting an email address or other information that can or could potentially identify users). This new anonymized version will be compared in a partially randomized patient preference trial with an already well-evaluated version in which, as is common in other digital health applications, personal data such as the email address or other information from the users is used, for example, for login.
Study objectives:
- To investigate the efficacy of a completely anonymous version of the program "JOURNeY" based on cognitive behavioral therapy (CBT) and compare it to an already evidence-based non-anonymous version of the program regarding primary social anxiety symptoms, and secondary outcomes such as depressive symptoms, quality of life, usability, adherence to the program, internalized stigma, attitudes on help-seeking, and personality functioning.
- To investigate patients' preferences and the influence of patients' preferences on outcome.
- To explore how patient characteristics are associated with participants' preferences.
详细描述
Social Anxiety Disorder (SAD) is one of the most widespread mental illnesses and it has previously been shown that online therapy and online self-help tools such as the one investigated in this study can be successful in reducing not only symptoms of SAD but also symptoms of depression and increase the quality of life of participants. A substantial concern with digital health intervention tools is data security and privacy as many such tools have been found to be unsafe and easy targets for hacker attacks, potentially endangering personal (health) data of the users.
For this research project, an internet-based program targeting social anxiety has been developed that can be used completely anonymously (i.e., without collecting an email address or other information that can or could potentially identify users). It is originally based on the well-established cognitive-behavioral treatment of social anxiety by Clark and Wells from 1995. This new anonymized version will be compared in a partially randomized patient preference trial with an already well-evaluated version in which, as is common in other digital health applications, personal data such as the email address or other information from the users is used, for example, for login. The fully anonymized version has some disadvantages regarding usability and possibly also effectiveness, as no usage history can be stored, users cannot pick up where they left off during a new login, and instead of entering texts in diaries, for example, about anxiety-related thoughts within the program, they need to download a PDF, etc. On the other hand, the anonymized version has advantages regarding the low threshold for use and privacy. People who could benefit from such internet-based programs might be more likely to use them, as there are no data protection risks associated with their use, and a fully anonymized version could immediately be used even without entering an email address. Thus, the reach and impact of evidence-based digital tools for mental problems and disorders such as social anxiety (disorder) could be increased with an anonymous version. However, there are no studies on the effectiveness of digital tools which can be used anonymously and there is no knowledge about the preferences of users (e.g., is it important for users to be able to use an anonymous version, or do they prefer the non-anonymized version with a few practical advantages?).
Study objectives:
- To investigate the efficacy of a completely anonymous version of the CBT-based program "JOURNeY" and compare it to an already evidence-based non-anonymous version of the program regarding primary social anxiety symptoms, and secondary outcomes such as depressive symptoms, quality of life, usability, adherence to the program, internalized stigma, attitudes on help-seeking, and personality functioning.
- To investigate patients' preferences and the influence of patients' preferences on outcome.
- To explore how patient characteristics are associated with participants' preferences.
This study is part of a larger trial conducted with two departments at the University of Bern. One part assesses clinical research questions and the other part is concerned with psychology of digitalization which researches user behavior and concerns regarding privacy in digital health applications.
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
- Single (Investigator)
盲法说明
The investigators will not know which specific condition the participants were in for the initial analysis. The blind will be broken for the investigators after first interpretation of the results.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Be 18 years or older,
- •Have access to the internet
- •Have access to a smartphone, computer or tablet
- •Score 22 points or higher on the Social Phobia Scale or 33 points or higher on the Social Interaction Anxiety Scale (SPS & SIAS)
排除标准
- •Score 2 points or higher on the suicide item of the PHQ-9
- •Have previously been diagnosed with psychotic symptoms or bipolar disorder
研究组 & 干预措施
Randomized Anonymous
After participants are randomized to the randomization arm, they will once again be randomized to the program versions. Participants in this arm will use the anonymous program.
干预措施: JOURNeY anonymous (Other)
Randomized Standard
After participants are randomized to the randomization arm, they will once again be randomized to the program versions. Participants in this arm will use the standard program.
干预措施: JOURNeY standard (Other)
Preferred Anonymous
After participants are randomized to the preference arm, they will be given access to the program version they indicate a preference for after having read two descriptive texts about both versions. Participants in this arm will use the anonymous program.
干预措施: JOURNeY anonymous (Other)
Preferred Standard
After participants are randomized to the preference arm, they will be given access to the program version they indicate a preference for after having read two descriptive texts about both versions. Participants in this arm will use the standard program.
干预措施: JOURNeY standard (Other)
结局指标
主要结局
Social Anxiety Symptoms
时间窗: at baseline, 8 Weeks
Change from baseline in the composite score of two self-report social anxiety questionnaires measuring various symptoms from time pre to time post (Social Phobia Scale \& Social Interaction Anxiety Scale; SPS \& SIAS). The scales contain a total of 40 items resulting in scores of 0 to 160 with higher scores indicating more severe social anxiety symptoms. The composite score will be the averaged z-score of both questionnaires.
次要结局
- Attitudes Towards Help-Seeking(at baseline, at 8 weeks, at 24 weeks)
- Personality Functioning(at baseline, at 8 weeks, at 24 weeks)
- Social Anxiety Symptoms(at baseline, at 8 weeks, at 24 weeks)
- Depressive Symptoms(at baseline, at 8 weeks, at 24 weeks)
- Internalized Stigma(at baseline, at 8 weeks, at 24 weeks)
- Social Anxiety Symptoms(at baseline, at 8 weeks, at 24 weeks)
- Depressive Symptoms(at baseline, at 8 weeks, at 24 weeks)
- Quality of Life QoL(at baseline, at 8 weeks, at 24 weeks)
- Internalized Stigma(at baseline, at 8 weeks, at 24 weeks)
- Attitudes Towards Help-Seeking(at baseline, at 8 weeks, at 24 weeks)
- Personality Functioning(at baseline, at 8 weeks, at 24 weeks)