An Expert System to Reduce Depression in Primary Care
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 902
- 试验地点
- 4
- 主要终点
- Change in Depression Severity
研究概览
简要总结
The purpose of this study is to determine whether a home-based intervention matched to stage of change (readiness) for using effective methods to prevent or reduce depression can improve depression outcomes in primary care.
详细描述
A variety of effective interventions exist for people who are willing to seek help for depression. However, there is a lack of interventions for individuals who are not willing to seek help or follow through with treatment recommendations. This is the first population-based intervention for depression that is appropriate for individuals in all stages of change-not merely the minority who are prepared to take action. Two primary care samples were included: 1) patients at risk for or experiencing depression but not involved in or planning treatment (Untreated Sample), and 2) patients newly prescribed antidepressant medication (Antidepressant Sample). Patients from both samples were randomly assigned to receive the intervention consisting of telephone assessments, a stage-based workbook, and three individualized, computer-generated reports mailed to the home (n=443), or usual care (n=459). Primary outcomes, assessed at 9 months, were change in depression severity, reliable and clinically significant change in depression severity, stage of change for using effective methods or prevent or reduce depression, onset of major depression if experiencing only subclinical symptoms at baseline, and medication adherence. The study design included an examination of whether the intervention effect was moderated by primary care sample, baseline use of effective methods to prevent or reduce depression, and level of depression.
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
- 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
- •At risk for or experiencing depression (i.e., Beck Depression Inventory-II (BDI) score of 10 or higher; current major depression, minor depression, or dysthymia; or past major depression, minor depression, or dysthymia)
排除标准
- •Younger than age 18
- •Involved in counseling or planning counseling in the next 30 days
- •Taking antidepressant medication or planning to take antidepressants in the next 30 days (exclusion criterion for Untreated Sample only)
- •Suicidal ideation
- •Severe depression (BDI > 28) and deemed inappropriate for study by site clinician
- •BDI <10 and in the Maintenance stage for using effective methods to prevent or reduce depression
- •History of bipolar disorder
结局指标
主要结局
Change in Depression Severity
时间窗: Baseline, 9 months
Depression was assessed using the Beck Depression Inventory, 2nd Edition (BDI-II)(Beck, Steer, \& Brown, 1996). In this self-report measure, 21 symptoms of depression are rated on a 0-3 scale. Scores for the 21 items are summed to yield a total score ranging from 0 to 63. The change scores reported here are the difference between the total BDI-II scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -63 to +63, with larger negative scores indicating greater reduction in depression.
次要结局
- Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression.(9 months)
- Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity(9 months)
- Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up(9 months)
- Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)(9 months)
- Change in Physical Functioning(Baseline, 9 months)