A Treatment for Depression Via App-Based FTP (Game4Mood Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hedonia Ltd
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Change in depression scores on the Montgomery-Åsberg Depression Rating Scale (MADRS clinical assessment)
研究概览
简要总结
The study is a randomized controlled treatment study comparing changes in depressive symptoms over 8 weeks between individuals with Major Depressive Disorder (MDD) who have access to an FTP-based mobile phone application and a control group not engaging with the app. FTP, the process of Facilitating Thought Progression, trains the brain's cognitive thought process to expand, accelerate, and be more creative, to alleviate depressive symptoms.
详细描述
This project aims to determine the effectiveness of an FTP-based mobile phone application in the alleviation of clinical symptoms of depression. In an attempt to change thought progression to be broader and more readily expansive, we had translated paradigms meant to expand thinking patterns into engaging mobile games. Our hypothesis is that the FTP-based mobile phone application will be able to decrease depressive clinical symptoms in a significant manner.
Participants meeting the inclusion criteria will be asked to play the app and undergo clinical and self-assessment evaluations regularly over the course of 8 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting Adults, ages 20-50
- •Able to read, understand and provide written informed consent in English
- •Participants who are the sole users of an iPhone or an Android smartphone, and agree to download and use the digital mobile phone application as required by the protocol
- •Participants who are comfortable using applications and games on their smartphones
- •Participants with a current primary diagnosis of MDD or mild depression. MADRS≥15 and <35
- •Participants who are taking any medications which are FDA approved or used off-label for mood or anxiety should be on a stable dosage for the past 6 weeks and have no plan to change dosage during the 8 weeks they will be in the study
- •Participants who are receiving therapy should have been with the same therapist for the previous 60 days and have no plan to change therapy protocol during the 8 weeks of the study
排除标准
- •Participants who have plans to change their medications which are FDA approved or used off-label for mood or anxiety or their therapy protocol during the 8 weeks of the study
- •Participants who have made any changes to their therapy protocol, including starting therapy, stopping therapy, or changing providers within the past 60 days
- •Participants who have made any changes to medications which are FDA-approved or used off-label for mood or anxiety in the last 6 weeks
- •Participants who have used a computer, web, or smartphone software-based application for mental health or depression in the last 6 weeks
- •Being at imminent risk for Suicidal behavior (via MINI)
- •Note: Other protocol-defined exclusion criteria applied.
结局指标
主要结局
Change in depression scores on the Montgomery-Åsberg Depression Rating Scale (MADRS clinical assessment)
时间窗: Baseline, week 4, and week 8
Validated clinician-based assessment; a 10-item scale with total scores between 0 and 60 where higher scores indicate greater depression severity
Change in Anhedonia level on the Snaith-Hamilton Pleasure Scale (SHAPS)
时间窗: From baseline to week 8, one time per week
Validated self-report questionnaire; a 14-item scale with total scores between 0 and 14 where higher scores indicate higher levels of anhedonia
Change in breadth of thought and ruminations scores on the Ruminative Response Scale (RRS)
时间窗: From baseline to week 8, one time per week
Validated self-report questionnaire; a 22-item scale with total scores between 22 and 88 where higher scores indicate higher degrees of ruminative symptoms
次要结局
- Change in depression symptoms severity on the Patient Health Questionnaire (PHQ-9)(From baseline to week 8, one time per week)
- Change in depression symptoms severity on the Symptoms of Depression Questionnaire (SDQ)(Baseline, week 4, and week 8)
- Change in anxiety measure on the General Anxiety Disorder-7 (GAD-7)(From baseline to week 8, one time per week)
- Change in quality of life score as assessed by the World Health Organization Quality of Life scale - short version (WHO-QOL BREF)(Baseline, week 4, and week 8)
- Change in mood scores on the Positive and Negative Affect Schedule (PANAS)(From baseline to week 8, one time per week)
- Change in performance in the game(continuous use during the 8-week study)
- Change in engagement levels(continuous use during the 8-week study)
研究者
Paola Pedrelli
Principal Investigator: Assistant Professor Harvard Medical School, Associate Director Depression Clinical Research Program
Massachusetts General Hospital