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临床试验/NCT05050227
NCT05050227已完成不适用

Improving Depression Management in Primary Care (CDA 19-108)

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Patient Health Questionnaire (PHQ-9)

研究概览

简要总结

Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PC-MHI) enables specialists to support medication treatment in primary care, but timely and sufficient access to psychotherapy is unattainable despite Veteran preference for psychotherapy. This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting and pilot testing PC-MHI collaborative care models to improve uptake of computerized cognitive behavioral therapy (cCBT).

详细描述

Background: VA's Primary Care-Mental Health Integration (PC-MHI) is rooted in evidence-based collaborative care models, where care managers, mental health specialists, and primary care providers jointly treat depression in primary care. While PC-MHI enabled specialists to support medication treatment in primary care, timely and sufficient access to psychotherapy is unattainable. Alternative therapy modalities are needed.

Significance/Impact: Depression is disabling and affects one in five Veterans. Psychotherapy is preferred by Veterans, but fraught with multilevel barriers (e.g., staff availability, patient travel to clinic, limited clinic hours). Without enhancing existing PC-MHI models to enable better primary care patient access to effective psychotherapies, Veteran engagement in depression treatment is unlikely to improve.

Innovation: This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting PC-MHI collaborative care models to improve uptake of computerized cognitive behavioral therapy (cCBT). cCBT is accessible 24/7 via the internet and has effectively treated depression in more than 30 trials. With modest specialist support, it is non-inferior to face-to-face psychotherapy. PC-MHI can facilitate Veteran uptake of cCBT, using an evidence-based collaborative care model to provide the follow-up care management and mental health specialist back-up that characterizes the most effective cCBT trials.

Specific Aims/Methodology: To pilot test the feasibility, acceptability, and potential effects of cCBT-enhanced collaborative care on Veterans' depression symptoms and related outcomes in VA Greater Los Angeles Healthcare System. A pilot randomized controlled trial (RCT) will be conducted to examine feasibility, acceptability, and potential effects on depression, patient activation, and health-related quality of life in VA primary care patients with depression receiving either (1) cCBT-enhanced collaborative care (n=37) or (2) usual care (n=37) in West Los Angeles VA, from baseline to 3-months (post-intervention).

Next Steps/Implementation: Adapting PC-MHI's collaborative care model to incorporate cCBT can improve access to psychotherapy and engage the ~400,000 untreated Veterans with depression who prefer psychotherapy, especially OIF/OEF/OND Veterans seeking care that is convenient.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Have access to computer (mobile or desktop), internet, telephone, and email
  • •Able to read English text on a computer screen
  • •Score 10 or higher on the PHQ-9

排除标准

  • •Have moderate-high suicide risk (e.g., suicide flag) or active suicidality
  • •Have other serious mental illness (e.g. bipolar disorder, psychosis)
  • •Have medical disorder that would prevent/interfere with participation (e.g. dementia/cognitive impairment, terminal illness)

研究组 & 干预措施

cCBT Enhanced Collaborative Care

Experimental

Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.

干预措施: cCBT Enhanced Collaborative Care (Behavioral)

Usual Care

Active Comparator

Participants in the usual care arm will receive the usual care provided as described below.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Patient Health Questionnaire (PHQ-9)

时间窗: 3-months

The Patient Health Questionnaire (PHQ-9) is a scale commonly used to measure and categorize depression symptoms. It is already administered as part of routine primary care at our study site. The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms).

次要结局

  • PROMIS Global Health(3-months)
  • Generalized Anxiety Disorder (GAD-7)(3-months)
  • Patient Activation Measure (PAM)(3-months)
  • PTSD Checklist for DSM-5 (PCL-5)(3-months)
  • Behavioral Activation for Depression Scale (BADS-SF)(3-months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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