Augmented Depression Therapy (ADepT) Case Series
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care.
ADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly.
As part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Aged 18 -65
- •Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First & Williams, 2021)
- •Scoring > 10 on the PHQ-9
- •Have sufficient knowledge of written and spoken English to provide consent and utilize therapy resources and take assessment measures throughout the protocol without the assistance of a translator.
排除标准
- •Diagnosis of a psychotic or bipolar disorder
- •History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)
- •Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment
- •Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame
- •Patients cannot be enrolled while they are currently receiving psychotherapy from a different provider in line with current clinic policy and APA ethical guidelines. The possibility of switching providers/treatments will be addressed following established departmental policies and procedures, transcranial magnetic stimulation, ketamine, esketamine, or electroconvulsive therapy. Patients receiving a stable dose of an antidepressant agent will be considered eligible.
- •Presence of another psychiatric disorder judged to be primary
结局指标
主要结局
Acceptability
时间窗: From enrollment to the end of treatment at 82 weeks
Patient ratings of treatment acceptability
Attrition
时间窗: From enrollment to the end of treatment at 82 weeks.
Patient attendance records
Adverse Events
时间窗: From enrollment to the end of treatment at 82 weeks.
Self-reported adverse events
次要结局
- Patient Health Questionnaire - 9 Item Version (PHQ-9)(From enrollment to the end of treatment at 82 weeks.)
- Montgomery-Asberg Depression Rating Scale (MADRS)(From enrollment to the end of treatment at 82 weeks.)
- Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)(From enrollment to the end of treatment at 82 weeks.)
研究者
Jay Fournier
Principal Investigator
Ohio State University