Online Positive Emotion Skills Intervention for Symptoms of Depression (MARIGOLD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 677
- 试验地点
- 2
- 主要终点
- Change in Retention Over Time (average of 4.5 months through study completion)
研究概览
简要总结
Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans with depression receive adequate treatment, and one-third of those receiving treatment do not benefit. In this pilot project investigators will bring together two approaches that have the promise to reach large numbers of depression sufferers: a skills-based intervention for increasing positive affect and experiences in depressed individuals, delivered in an inexpensive self-paced mobile format. The study will make use of smartphone technology to improve conventional outcome measurement via in-the-moment emotion sampling and mobile assessment of heart rate variability, a predictor of cardiac health that may mediate some of the health effects of depression. The aims are: 1) Retool the existing web-based positive emotion intervention for use on smartphones, with innovative exercises that help participants bring the skills they are learning into real-life situations; 2) Perform a small feasibility trial of the mobile intervention on individuals with clinical depression recruited online 3) Eventually incorporate feedback from the small feasibility trial to improve the online intervention and conduct a full randomized trial on a larger scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Daily internet access
- •Cell phone ownership
- •Score of 5 or higher on PHQ-8 scale
- •Lives in US or Canada
- •Speaks and reads English, able to provide informed consent
排除标准
- 未提供
结局指标
主要结局
Change in Retention Over Time (average of 4.5 months through study completion)
时间窗: From the start of the 5-week online intervention (Weeks 1-5), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). Data collected for the duration of the entire study.
Determine the percentage of participants providing data at each stage of the study from baseline to study completion (average of 4.5 months). This includes capturing dropout rates and reasons for dropping out, where possible; Retention will also include analyzing any qualitative comments/feedback on the lessons and home practice exercises in order to gauge what participants like and don't like, and what is feasible for future iterations of this study to maximize retention.
Change in Depression symptoms (PHQ-8 questionnaire) Over Time (4.5 months through study completion)
时间窗: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
8-items; responses range from 0 "not at all" to 3 "almost every day"
Change in Depression symptoms (CES-D questionnaire) Over Time
时间窗: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
20-items; responses range from 1 "rarely or none of the time (less than 1 day)" to 3 "occasionally or a moderate amount of the time (3-4 days)"
次要结局
- Change in Brief Resilience Scale (BRS) over time (4.5 months of participation in the study)(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Positive and Negative Affect (DES questionnaire) Over Time ("past week")(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Mindfulness Over Time: Five Facet Mindfulness Questionnaire (FFMQ)(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Stress: Perceived Stress Scale (PSS questionnaire) Over Time(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Meaning and Purpose Scale over time (4.5 months of participation in the study)(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Positive Affect and Well-Being Short Form from the Neuro-QOL Item Bank(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Skills Use Questionnaire (measuring change in application/use of positive affect skills over 4.5 months)(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in General Behavior Inventory (GBI) Scale(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Stress Management Self-Efficacy (SMSE)(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Expectancy Credibility Scale(Administered once at the initial questionnaire prior to Week 1 of the intervention.)
- Change in Prioritizing Positivity Over Time (Prioritizing Positivity Scale)(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Behavioral Activation for Depression Scale (BADS)(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Self-Stigma Depression Scale (SSDS)(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Depression Self Stigma Scale (DSSS) over time (4.5 months of participation in the study)(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
- Change in Self Compassion Scale (SCS) Short-Form(From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).)
研究者
Judith Moskowitz
Professor
Northwestern University