Bendig Eileen, Meißner Dominik, Erb Benjamin, Weger Lena, Küchler Ann-Marie, Bauereiss Natalie, Ebert David, Baumeister Harald
Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany
Department of Computer Science, Institute of Distributed Systems, Ulm University, Ulm, Germany.
BMJ Open. 2021 Feb 8;11(2):e041573. doi: 10.1136/bmjopen-2020-041573.
Only a minority of people living with mental health problems are getting professional help. As digitalisation moves on, the possibility of providing internet/mobile-based interventions (IMIs) arises. One type of IMIs are fully automated conversational software agents (chatbots). Software agents are computer programs that can hold conversations with a human by mimicking a human conversational style. Software agents could deliver low-threshold and cost-effective interventions aiming at promoting psychological well-being in a large number of individuals. The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group.
Within a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. SISU is based on therapeutic writing and acceptance and commitment therapy-based principles. The brief intervention consists of three modules. Participants work through the intervention on 3 consecutive days. Assessment takes place before (t1), during (t2) and after (t3) the interaction with SISU, as well as 4 weeks after randomisation (t4). Primary outcome is psychological well-being (WHO-5). Secondary outcomes are emotional well-being (Flourishing Scale), psychological flexibility (Acceptance and Action Questionnaire-II), quality of life (Assessment of Quality of Life -8D), satisfaction with the intervention (Client Satisfaction Questionnaire-8) and side effects (Inventory for the assessment of negative effectsof psychotherapy). Examined mediators and moderators are sociodemographic variables, personality (Big Five Inventory-10), emotion regulation (Emotion Regulation Questionnaire), alexithymia (Toronto Alexithymia Scale-20), centrality of events (Centrality of Events Scale), treatment expectancies (Credibility Expectancy Questionnaire) and technology alliance (Inventory of Technology Alliance-Online Therapy). Data analysis will be based on intention-to-treat principles. SISU guides participants through a 3-day intervention.
This trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). Results will be submitted for publication in a peer-reviewed journal and presented at conferences.
The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS): DRKS00016799 (date of registration: 25 April 2019). In case of important protocol modifications, trial registration will be updated. This is protocol version number 1.
仅有少数心理健康问题患者能获得专业帮助。随着数字化的发展，提供基于互联网/移动设备的干预措施（IMIs）成为可能。IMIs的一种类型是全自动对话软件代理（聊天机器人）。软件代理是一种计算机程序，能够通过模仿人类对话风格与人类进行对话。软件代理可以提供低门槛且经济高效的干预措施，旨在促进大量个体的心理健康。本试验的目的是评估基于软件代理的简短IMI SISU与等待名单对照组相比的临床效果和可接受性。
在一项两组随机对照试验中，将在德国、奥地利和瑞士招募总共120名幸福感较低（幸福感量表/WHO-5）的成年参与者。SISU基于治疗性写作以及基于接受与承诺疗法的原则。简短干预由三个模块组成。参与者连续3天完成干预。在与SISU互动之前（t1）、期间（t2）和之后（t3）以及随机分组后4周（t4）进行评估。主要结局是心理健康（WHO-5）。次要结局包括情绪幸福感（蓬勃发展量表）、心理灵活性（接受与行动问卷-II）、生活质量（生活质量评估-8D）、对干预的满意度（客户满意度问卷-8）以及副作用（心理治疗负面影响评估量表）。研究的中介变量和调节变量包括社会人口统计学变量、人格（大五人格量表-10）、情绪调节（情绪调节问卷）、述情障碍（多伦多述情障碍量表-20）、事件中心性（事件中心性量表）、治疗期望（可信度期望问卷）以及技术联盟（技术联盟量表-在线治疗）。数据分析将基于意向性分析原则。SISU指导参与者完成为期3天的干预。
本试验已获得乌尔姆大学伦理委员会批准（编号448/18，2019年2月18日）。研究结果将提交至同行评审期刊发表，并在会议上展示。
该试验通过德国临床试验注册中心（DRKS）在世界卫生组织国际临床试验注册平台注册：DRKS00016799（注册日期：2019年4月25日）。如有重要的方案修改，试验注册信息将更新。这是方案版本号1。
