Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire - 9
研究概览
简要总结
Computer-assisted cognitive-behavior therapy, a treatment that has been shown to be effective in previous studies in psychiatric settings, will be disseminated into primary care - a health care setting where there are significant problems in receiving adequate treatment for depression. Computer-assisted cognitive-behavior therapy will feature a low-cost method of delivering therapy designed to be replicated and sustained in other primary care settings. Feasibility and effectiveness will be tested by randomly assigning 320 primary care patients with depression to receive either computer-assisted cognitive-behavior therapy or treatment as usual.
详细描述
Computer-assisted cognitive-behavior therapy (CCBT) for depression in primary care will be evaluated in a trial with 320 patients randomly assigned to CCBT or treatment as usual (TAU). The study will disseminate a therapy method found to be effective in psychiatric settings into primary care - a setting where there have been significant problems in delivery of adequate, evidence-based treatment for depression. The study will include a high percentage of disadvantaged patients - a population that has been largely ignored in previous research in CCBT. There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients. The form of CCBT used in this study is designed to increase access to effective therapy, provide a cost-effective method, and be a sustainable model for wide-spread use in primary care.
In order to deliver therapy in a practical manner that can be replicated in other primary care practices, patients with significant symptoms of depression will receive treatment with an empirically supported computer program that builds cognitive-behavior therapy skills. Support for CCBT will be provided by telephone and/or e-mail contact with a care coordinator instead of the face-to-face treatment with a cognitive-behavior therapist that has been a part of CCBT delivery in mental health settings. Novel features of this treatment program include: 1) fully detailed and replicable method for integrating clinician support with CCBT in primary care; 2) delivery of CCBT to a population with high percentage of disadvantaged patients; 3) integration of CCBT into the primary care delivery model; 4) highly interactive, multimedia computer program with adaptations for persons who may have lower levels of education or computer experience; 5) advanced cost-benefit analysis including data on actual health care utilization and costs; 6) exploration of moderators and predictors of treatment outcome.
Outcome will be assessed by measuring CCBT completion rate, comprehension of CBT concepts, and satisfaction with treatment; in addition to ratings of depressive symptoms, negative thoughts, and quality of life. The cost-effectiveness analysis and exploration of possible predictors of outcome should help clinicians, health care organizations, and others plan further dissemination of CCBT in primary care.
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
- •Patient Health Questionnaire score of 10 or above
- •Age 18 or above
排除标准
- •Refusal to provide informed consent
- •Inability to read English text on computer screen
- •Significant suicidal thoughts, intent, plan, or behavior reported on Columbia Suicide Severity Rating Scale
- •Severe or poorly controlled medical disorders that would interfere with participation in CCBT (e.g., liver failure, terminal cancer)
- •Dementia or other organic brain disorders that would prevent participation in CCBT
- •Diagnosis of any psychotic disorder or bipolar disorder.
研究组 & 干预措施
Computer-assisted CBT (CCBT)
12 weeks of CCBT for depression
干预措施: Computer-assisted CBT (CCBT) (Behavioral)
Treatment as Usual (TAU)
Treatment as usual by primary care physicians
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Patient Health Questionnaire - 9
时间窗: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Self-report scale for depression
次要结局
- Quality of Life Enjoyment and Satisfaction Questionnaire(Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends)
- Quality of Well Being Scale(Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends)
- Patient Attitudes and Expectations Scale(Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends)
- Automatic Thoughts Questionnaire(Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends)
- Client Service Receipt Inventory(Change from baseline after 12 weeks of treatment and 3 and 6 months after 12-week treatment ends)
- Generalized Anxiety Disorder - 7(Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends)
研究者
Jesse H Wright
Professor
University of Louisville