Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Changes in depression as assessed by Patient Health Questionnaire-9
研究概览
简要总结
This is a prevention intervention study that will examine the efficacy of a smartphone-based intervention in decreasing cancer risk by targeting mental health risk factors of anxiety and depression.
详细描述
This prevention intervention study aims to examine the efficacy of a smartphone-based intervention in decreasing cancer risk by targeting mental health risk factors of anxiety and depression. The study will utilize a smartphone application called Mood Triggers, designed to provide personalized feedback on individuals' maintenance factors (i.e., "triggers") of their anxiety and depressive symptoms. Mood Triggers delivers ultra-brief interventions (less than 2 minutes long) where participants view videos introducing important skills to treat their anxiety and depression. The study targets middle-aged adults (40-64 years old) who meet current criteria for moderate to severe anxiety and/or depressive disorders. It will enroll an anticipated 100 participants in a single-group, open-label design, with the intervention lasting up to 12 weeks. The primary outcomes include changes in depression and anxiety symptoms, measured by the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-Q-IV Scale, respectively, as well as changes in cancer risk assessed by the World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Middle-aged adults (age 40 to 64).
- •fluent in English.
- •Able to provide informed consent.
- •Meets current criteria for an anxiety and/or depressive disorder with severity ranging from moderate to severe (based on the Patient Health Questionnaire - 9 and the Generalized Anxiety Disorder Questionnaire).
- •Owns a smartphone.
排除标准
- •Acute psychosis (based on the self-reported Structured Interview for Psychosis risk Syndromes, Prodromal Questionnaire - Brief version [SIPS PQ-B]).
- •Moderate to high suicidal ideation (based on a response of 2 or more on the PHQ-9 item-9).
- •History of bipolar disorder (based on the self-reported Mood Disorder Questionnaire [MDQ].
- •Past or current diagnoses of cancer.
- •Changes to treatments or medications in the past 30 days.
结局指标
主要结局
Changes in depression as assessed by Patient Health Questionnaire-9
时间窗: 12 weeks post-baseline
Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity
Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
时间窗: 12 weeks post-baseline
Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
World Cancer Research Fund (WCRF)/ American Institute for Cancer Research (AICR) Cancer Prevention Score.
时间窗: Up to 12 weeks after enrollment
Minimum score: 0, Maximum score: 7-8 (8 for persons capable of breastfeeding). Greater scores suggest lower cancer risk.
次要结局
- Smartphone estimates of sociability as mechanisms of change in cancer risk(Up to 12 weeks after enrollment)
- Momentary Assessment of Anxiety Symptom Changes(Up to 12 weeks after enrollment)
- Momentary Assessment of Behavioral Avoidance Symptom Changes(Up to 12 weeks after enrollment)
- Diet as mechanism of change in cancer risk(Baseline, 6 weeks post-baseline, 12 weeks post-baseline)
- Momentary Assessment of Arousal Symptom Changes(Up to 12 weeks after enrollment)
- Momentary Assessment of Depression Symptom Changes(Up to 12 weeks after enrollment)
- Momentary Assessment of Hopelessness Symptom Changes(Up to 12 weeks after enrollment)
- Smartphone estimates of motion activity as mechanisms of change in cancer risk(Up to 12 weeks after enrollment)
研究者
Nicholas Jacobson
Assistant Professor of Biomedical Data Science and Psychiatry
Trustees of Dartmouth College