跳至主要内容
临床试验/NCT06375083
NCT06375083招募中2 期

Implementing Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression Among At-Risk Rural and Urban Veterans

VA Eastern Colorado Health Care System1 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2024年3月20日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
472
试验地点
1
主要终点
Client Satisfaction Questionnaire

研究概览

简要总结

This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors.

详细描述

Based on previous work with other computerized CBT (cCBT) interventions (e.g., cCBT-D), which has found that cCBT has similar effectiveness to traditional CBT, members of the team along with Veterans Health Administration (VHA) leaders have developed computerized cCBT-SP and cCBT-D courses that will be ready for safety, feasibility, and acceptability testing. If proven to be feasible, safe, and effective, these courses could be made available to all Veterans, at no cost to users.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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
是

入选标准

  • •Cohort A - cCBT-SP Program
  • •Inclusion Criteria:
  • •Veterans between the ages of 18 and 65
  • •Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA Care
  • •Recent suicidal ideation (past month; C-SSRS Screener -Yes to Item 2) and history of lifetime suicidal behavior (lifetime, C-SSRS Screener - Yes to Item 6)
  • •Reliable access to a computer/tablet and the internet
  • •Ability to provide informed consent

排除标准

  • •Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record
  • •Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record
  • •Severe cognitive impairment, as determined by screening or electronic medical record
  • •Currently enrolled in/participating in another mental health-related intervention research study
  • •Cohort B - cCBT-D Program
  • •Inclusion Criteria:
  • •Veterans between the ages of 18 and 65
  • •Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA care
  • •Mild to moderate depressive symptoms, as determined by the PHQ-9, (score of 5-14)
  • •Reliable access to a computer/tablet and the internet
  • •Ability to provide informed consent
  • •Exclusion Criteria:
  • •PHQ-9 score below 4 or 15 and above
  • •Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record
  • •Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record
  • •Severe cognitive impairment, as determined by screening or electronic medical record
  • •Currently enrolled in/participating in other intervention research study

研究组 & 干预措施

c-CBT for Suicide Prevention

Experimental

CBT for Suicide Prevention

干预措施: c-CBT for Suicide Prevention (Behavioral)

c-CBT for Depression

Experimental

Computerized CBT for Depression

干预措施: c-CBT or Depression (Behavioral)

结局指标

主要结局

Client Satisfaction Questionnaire

时间窗: 12 weeks

Acceptability

Narrative Evaluation of Intervention Interview

时间窗: 12 weeks

Acceptability

Internet Evaluation and Utility Questionnaire

时间窗: 12 weeks

Acceptability

Internet Impact and Effectiveness Questionnaire

时间窗: 12 weeks

Acceptability

Recruitment Rate

时间窗: 12 weeks

Number of individuals who consented to participate

Completion of intervention

时间窗: 12 weeks

Number of participants who completed most or all of the sessions

次要结局

  • Patient Health Questionnaire-9(12 weeks)
  • Generalized Anxiety Disorder-7(12 weeks)
  • Computerized Adaptive Testing - Suicide Scale(12 weeks)
  • Posttraumatic Stress Disorder Checklist-5(12 weeks)
  • Beck Scale for Suicide Ideation(12 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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