NCT06590038已完成不适用
Psychotherapy Feasibility and Acceptability Pilot of the Carolina Recovery From Depression Protocol (CARED): A Novel Rapid Treatment Paradigm for Depression
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- CARED Treatment Experience Survey
研究概览
简要总结
The goal of this clinical trial is to learn whether an single session intervention can reduce psychological impairment in adult individuals with moderate depression. The main questions it aims to answer are:
Is this evidence-based intervention acceptable to study participants? Is this evidence-based intervention feasible to implement in a single session? Is there evidence that the evidence-based intervention reduces psychological impairment in adults with moderate to severe depression?
Participants will complete:
- an in-depth diagnostic screening interview prior to enrollment
- a set of mental health questionnaires at baseline and two weeks post-intervention
- a 3-hour, evidence-based, single session psychotherapeutic intervention with a trained clinician
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older
- •Able to provide informed consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Speak and understand English
- •Diagnostic and Statistical Manual (DSM)-5 diagnosis of major depressive disorder (MDD) as confirmed by semi-structured clinical assessment
- •Meet a cutoff of at least a moderate depression score on the Beck Depression Inventory (BDI-II) (≥ 20)
排除标准
- •Participants must not have current active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
- •Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as assessed by psychodiagnostic assessment
- •Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
- •Participants able to birth must not be pregnant or breastfeeding.
- •Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
- •Participants may not have undergone prior brain surgery
- •Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
- •Participants may not have had brain injury or concussion within the last three months
- •Participants may not have a history of brain injury requiring current treatment
结局指标
主要结局
CARED Treatment Experience Survey
时间窗: Immediately post-intervention (same day)
A brief survey which probes the qualitative experience of participants during the intervention (i.e., tolerability, their level of engagement, satisfaction with treatment). Participants respond to eight items, rated on a 4-point Likert scale (1 - Not at all to 4 - Completely) to indicate their level of agreement with each item. Higher scores on the measure indicate greater tolerability, satisfaction, and endorsement of treatment. Total possible scores range from 8 to 32.
次要结局
- Change from baseline on Behavioral Activation Scale at two weeks post-intervention(Baseline and Two Weeks post-intervention)
- Change in baseline Repetitive Thinking Questionnaire - 10 item form to two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Snaith-Hamilton Pleasure Scale at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Inhibition Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Drive Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Fun Seeking Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Reward Responsiveness Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Quality of Life Enjoyment and Satisfaction Questionnaire at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Dimensional Anhedonia Rating Scale at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Intolerance of Uncertainty Scale at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Flexibility Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Multidimensional Psychological Flexibility Inventory (short form) - Inflexibility Subscale at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Self-Compassion Scale Short Form at two weeks post-intervention(Baseline and Two weeks post-intervention)
- Change from baseline on Becks Depression Inventory II at two weeks post-intervention(Baseline and Two weeks post-intervention)
研究者
研究点 (2)
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