Designing and Pilot Testing a Just-in-time Adaptive Intervention (JITAI) for Adolescent Depression Treatment in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Sleep disturbance
研究概览
简要总结
The goal of this clinical trial is to learn if a tailored smartphone intervention called Sidekick can help improve sleep and physical activity for teenagers in depression treatment. The main question it aims to answer is:
Does Sidekick help teens improve sleep or physical activity?
Teen participants will be asked to complete surveys about how they are feeling and doing at the beginning of the study and throughout their participation. All teen participants will be able to use the Sidekick app during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •13 to 17 years old
- •PHQ-8 score ≥5
- •PHQ-8 rating of ≥1 on anhedonia, sleep, or fatigue items
- •Own a personal smartphone
排除标准
- •Active safety concerns (e.g., acute suicidal ideation)
- •Diagnosed developmental disability (e.g., autism spectrum)
- •Primary mental health diagnosis other than MDD according to baseline Mini-international Neuropsychiatric Interview (MINI) (comorbidity allowed when MDD primary)
- •Sleep disorder from another medical cause
- •Inability to engage in moderate exercise because of medical concerns;
研究组 & 干预措施
Treatment arm
干预措施: Sidekick (Behavioral)
结局指标
主要结局
Sleep disturbance
时间窗: Baseline to 4 weeks
The PROMIS Sleep Disturbance 8a scale for adolescents is a self-report assessment of sleep difficulties over the past week. It includes 8 items related to sleep quality and disturbances rated on a 5-point scale. Raw scores (range: 8 - 40) are converted to normalized T-scores, with higher scores indicating greater sleep disturbance
Sleep related impairment
时间窗: Baseline to 4 weeks
The PROMIS Sleep-Related Impairment measure is a self-report assessment of the impact of sleep disturbances on daily functioning over the past week. It includes 8 items related to how sleep problems affect activities like school performance, mood, and social interactions, rated on a 5-point scale. Raw scores (range: 8-40) are converted to normalized T-scores, with higher scores indicating greater impairment in daily functioning due to sleep issues.
Physical Activity Questionnaire - Adolescent
时间窗: Baseline to 4 weeks
The Physical Activity Questionnaire for Adolescents (PAQ-A) is a self-report assessment of physical activity levels in adolescents over the past 7 days. It includes 9 items related to the frequency and intensity of various physical activities, with responses on a 5-point scale. Scores are summed and averaged, with higher scores indicating greater physical activity levels.
Sleep Quality
时间窗: Baseline to 4 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-report assessment of sleep quality over the past month. It includes 19 items covering sleep patterns, duration, disturbances, and daytime dysfunction. Response values are combined into components produce a global score (range: 0-21), with higher scores indicating poorer sleep quality and greater sleep-related difficulties.
次要结局
- Depression(Baseline to 4 weeks)
- Anxiety(Baseline to 4 weeks)
研究者
Jessica Jenness
Assistant Professor: Department of Psychiatry and Behavioral Sciences
University of Washington