Effectiveness of a Therapy Chatbot on Anxiety and Depressive Symptoms in Subclinical Young Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- PHQ-9 Score Change
研究概览
简要总结
This clinical trial compares the effects of using an artificial intelligence based therapy chatbot and a self-help book to lower anxiety and depressive symptoms. The therapy chatbot (named Fido) is an application delivering support for mental health via a conversation-like interface in a highly inflected language (Polish).
The team will recruit young people (aged 18-35) who currently struggle with anxiety and/or depression. The participants will use the chatbot or self-help materials for two weeks. Then, the researchers will check if using the chatbot or the book improved several aspects of mental health and the quality of life. Moreover, they will compare the groups for any differences in outcomes.
详细描述
The primary objective of this randomized controlled trial is to evaluate the effectiveness of a chatbot-delivered cognitive-behavioural intervention on anxiety and depressive symptoms (and their correlates, such as quality of life or feelings of loneliness) in a subclinical sample of about 80 participants.
The intervention results are compared to an active control intervention with popular self-help materials. Secondary objectives include the assessment and analysis of the human-chatbot therapeutic bond and general user experience.
The study uses a 2 x 3 mixed factorial design with two intervention arms (Fido chatbot vs self-help book) and three time points (T1: just prior to the intervention, T2: immediately after the intervention, T3: at a follow-up one month after the previous measurement). The primary intervention lasts two weeks.
All primary and secondary outcomes are assessed using self-administered online questionnaires in Polish. Each primary outcome measure is analyzed using a 2 (arms) x 2 (time points) ANOVA models with T1-T2 comparisons to test for the intervention effect and T1-T3 comparisons to check the stability of the intervention effect. Additional analyzes utilize standard NHST calculations and procedures (such as t-tests and correlation coefficients) alongside the conventional ⍺=.05 level.
Similarly to the previous research in this area, no blinding is used. Participants are informed about different conditions, but the research hypotheses are masked.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •declaring at least mild depressive or anxiety symptoms by achieving a total score of at least 16 points on Center for Epidemiologic Studies Depression Scale Revised or at least 50 points on Penn State Worry Questionnaire
- •being able to visit the study site in Poznań (Poland) to complete all measurements
排除标准
- •undergoing psychotherapy, coaching or psychopharmacological treatment
- •being diagnosed with a neurological disorder
结局指标
主要结局
PHQ-9 Score Change
时间窗: Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).
The total sum score of the Polish version of the Patient Health Questionnaire-9.
PSWQ Score Change
时间窗: Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).
The total sum score of the Polish version of the Penn State Worry Questionnaire.
R-UCLA Score Change
时间窗: Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).
The total sum score of the Polish version of the Revised UCLA Loneliness Scale.
CESD-R Score Change
时间窗: Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).
The total sum score of the Polish version of the Center for Epidemiologic Studies Depression Scale Revised.
STAI Score Change
时间窗: Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).
The total sum score of the Polish version of the State-Trait Anxiety Inventory.
SWLS Score Change
时间窗: Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).
The total sum score of the Polish version of the Satisfaction With Life Scale.
PANAS Score Change
时间窗: Time point 1: Just prior to the intervention. Time point 2: Immediately after two weeks of the intervention. Time point 3: One month after the previous measurement (time point 2).
The total sum scores of the Polish version of the Positive and Negative Affect Scale in two subscales (Positive and Negative Affect, separately).
次要结局
未报告次要终点