The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in The Patient Health Questionnaire-9
研究概览
简要总结
The study aims to assess the feasibility of a chatbot-based stress management intervention among youth in Lithuania.
详细描述
The intervention is a chatbot-based stress management intervention developed by the World Health Organization (WHO). It consists of 10 sessions which include: Introduction (1), Psychoeducation (2), Emotion Regulation (3, 4), Behavior Activation (5, 6), Managing Problems (7), Thought Challenging (8, 9), and Relapse Prevention (10). Each session consists of psychoeducation and exercise parts. Trained e-helpers contact participants to support them individually on a weekly basis.
The effect of the intervention will be compared against a control group which gets basic psychoeducation. The intervention is provided in Lithuanian.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-25 years
- •Understanding the Lithuanian language
- •Having access to a device for intervention delivery
- •Experiencing moderate levels of psychological distress
排除标准
- •People at imminent risk of suicide
- •People currently experiencing a psychotic episode
- •People currently experiencing interpersonal violence
- •Current dependency on alcohol/drugs
结局指标
主要结局
Changes in The Patient Health Questionnaire-9
时间窗: Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in symptoms of depression are measured. The Patient Health Questionnaire-9 (PHQ-9, Kroenke et al., 2001) is a self-report measure comprising 9 items about symptoms of depression. All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day). A higher score indicates more pronounced symptoms.
Changes in The Generalized Anxiety Disorder-7
时间窗: Before the intervention, immediately after the intervention, 3-months after the intervention
Changes in symptoms of anxiety are measured. The Generalized Anxiety Disorder-7 (GAD-7, Spitzer et al., 2006) is a self-report measure comprising 7 items about symptoms of anxiety. All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day). A higher score indicates more pronounced symptoms.
次要结局
- Changes in Kessler-6(Before the intervention, immediately after the intervention, 3-months after the intervention)
- Changes in The Brief Adjustment Disorder Measure-8(Before the intervention, immediately after the intervention, 3-months after the intervention)
- Changes in The SIDAS(Before the intervention, immediately after the intervention, 3-months after the intervention)
- Changes in The WHODAS 2.0(Before the intervention, immediately after the intervention, 3-months after the intervention)
- Changes in The World Health Organization Well-being Index-5(Before the intervention, immediately after the intervention, 3-months after the intervention)
- Changes in The International Trauma Questionnaire(Before the intervention, immediately after the intervention, 3-months after the intervention)
- Changes in The Resilience scale(Before the intervention, immediately after the intervention, 3-months after the intervention)
- Changes in The Client Services Receipt Inventory(Before the intervention, 3-months after the intervention)
- Changes in The EQ-5D-5L(Before the intervention, immediately after the intervention, 3-months after the intervention)
- Recruitment rate(Before the intervention)
- Drop-out rates(Immediately after the intervention, 3-months after the intervention)
- Number of adverse events and serious adverse events(Immediately after the intervention)
研究者
Evaldas Kazlauskas
Professor in clinical psychology
Vilnius University