A Single-Blind, Randomized, Controlled Trial of a Cognitive-Behavioral Therapy Digital Therapeutic to Combat Symptoms of Depression in Service Members and Adults With a History of MildTraumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report history of depression prior to mTBI compared to those who do not
研究概览
简要总结
The Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit has developed the first cognitive-behavioral therapy (CBT) digital therapeutic (DTx) mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury (mTBI). This trial will assess the efficacy of the novel CBT-DTx for depression following mTBI compared to an educational comparison DTx.
详细描述
This trial is a single-blind, randomized, controlled interventional trial of current and former military personnel with symptoms of depression and a history of mTBI. The study will be conducted remotely.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be aged ≥ 18 to ≤ 65 years
- •Be able to provide informed consent
- •Diagnosed with mild TBI as defined by the Department of Veteran's Affairs and Department of Defense Clinical Practice
- •Have a PHQ-9 score of ≥ 5 to 27, indicative of mild or greater depressive symptoms
- •Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities
- •While participating in this study, be able to ensure that you have access to regular care for mental health and to speak with your provider as necessary
排除标准
- •Report of starting pharmacological or non-pharmacological treatment for depression within the 3 months prior to trial enrollment
- •Report a recent change in type or dose of antidepressant medications within 12 weeks prior to trial enrollment
- •Report active psychotic or bipolar symptoms
- •Active plan and/or intent of suicide or homicide
- •In the opinion of the investigator, they have other considerations that may adversely affect patient safety, participation, or scientific validity of the data being collected
结局指标
主要结局
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report history of depression prior to mTBI compared to those who do not
时间窗: Week 12 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores, comparison between depression severity group
时间窗: Week 12 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total score
时间窗: Week 12 and Week 16 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report family history of depression compared to those who do no
时间窗: Week 12 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who complete all treatment modules compared to those who do not
时间窗: Week 12 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
次要结局
- Change of the mean difference in Insomnia Severity Index (ISI) total score(Week 12 and Week 16, compared to Baseline)
- Change in Credibility and Expectancy Questionnaire (CEQ)(Week 12 and Week 16, compared to Baseline)
- Change of the mean difference in Posttraumatic Stress Disorder Checklist (PCL-5) total score(Week 12 and Week 16, compared to Baseline)
- Blinding Efficacy(Week 12 and Week 16, compared to Baseline)
- Change of the mean difference in Traumatic Brain Injury-Quality of Life (TBI-QOL) total score(Week 12 and Week 16, compared to Baseline)