Effectiveness of a Guided Mental Health Chatbot STARS for Youth Living in Lithuania: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 262
- 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 effectiveness of a guided mental health chatbot called "Scalable Technology for Adolescents and youth to Reduce Stress (STARS)", adapted for youth living in Lithuania.
详细描述
The intervention is a guided mental health chatbot STARS 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), Supportive Self-talk (8, 9), and Relapse Prevention (10). Each session consists of psychoeducation and exercise parts. Trained and supervised non-specialists (called e-helpers) provide weekly calls (five calls lasting approximately 15 minutes) to support participants individually.
The effect of the intervention will be compared against a control group which receives enhanced usual care.
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 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 (a cut-off score of 8 as measured with Kessler-6)
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
研究组 & 干预措施
Intervention group
The intervention group will get a guided mental health chatbot STARS.
干预措施: STARS (Scalable Technology for Adolescents and youth to Reduce Stress) (Behavioral)
Control group
The control group will receive basic psychoeducation. The content of the psychoeducation is very similar to the content of session 2 of the STARS chatbot and includes psychoeducation about emotions, a personal story about a fictional character who talks about her emotions, and information about where to access mental health support. It also includes a list of organizations and clinics providing mental health care in Lithuania.
干预措施: Basic psychoeducation (Behavioral)
结局指标
主要结局
Changes in The Patient Health Questionnaire-9
时间窗: Baseline, eight weeks after baseline, three months after baseline
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. In the Lithuanian sample, the PHQ-9 had a good internal consistency with Cronbach's α of 0.85 (Nomeikaite et al., 2023).
Changes in The Generalized Anxiety Disorder-7
时间窗: Baseline, eight weeks after baseline, three months after baseline
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. In the Lithuanian sample, the GAD-7 had a good internal consistency with Cronbach's α of 0.91 (Nomeikaite et al., 2023).
Changes in The Patient Health Questionnaire-9
时间窗: Baseline, eight weeks after baseline, three months after baseline
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. In the Lithuanian sample, the PHQ-9 had a good internal consistency with Cronbach's α of 0.85 (Nomeikaite et al., 2023).
Changes in The Generalized Anxiety Disorder-7
时间窗: Baseline, eight weeks after baseline, three months after baseline
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. In the Lithuanian sample, the GAD-7 had a good internal consistency with Cronbach's α of 0.91 (Nomeikaite et al., 2023).
次要结局
- Changes in Kessler-6(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The Brief Adjustment Disorder Measure-8(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The SIDAS(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The WHODAS 2.0(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The World Health Organization Well-being Index-5(Baseline, eight weeks after baseline, three months after baseline)
- Changes in Internalized Stigma of Mental Illness(Baseline, eight weeks after baseline, three months after baseline)
- Changes in Self-Stigma of Seeking Help(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The Client Services Receipt Inventory(Baseline, three months after baseline)
- Changes in The EQ-5D-5L(Baseline, eight weeks after baseline, three months after baseline)
- Changes in Kessler-6(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The Brief Adjustment Disorder Measure-8(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The SIDAS(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The WHODAS 2.0(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The World Health Organization Well-being Index-5(Baseline, eight weeks after baseline, three months after baseline)
- Changes in Internalized Stigma of Mental Illness(Baseline, eight weeks after baseline, three months after baseline)
- Changes in Self-Stigma of Seeking Help(Baseline, eight weeks after baseline, three months after baseline)
- Changes in The Client Services Receipt Inventory(Baseline, three months after baseline)
- Changes in The EQ-5D-5L(Baseline, eight weeks after baseline, three months after baseline)
研究者
Evaldas Kazlauskas
Professor in clinical psychology
Vilnius University