A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Hamilton Rating Scale for Depression (HRSD)
研究概览
简要总结
This randomized clinical trial studies how well a computerized cognitive behavior therapy program works in treating depression in patients with cancer. The cognitive behavior therapy program uses a series of internet-delivered sessions intended to help patients identify and change problematic patterns of thinking and behavior that maintain depression.
详细描述
PRIMARY OBJECTIVES:
I. Establish the efficacy of computerized cognitive behavior therapy ("Beating the Blues") in reducing symptoms of depression and remission of major depressive disorder (MDD) in cancer patients.
II. Test the feasibility of implementation and patient acceptability of online computerized cognitive behavior therapy for cancer patients with major depressive disorder (MDD).
III. Test moderators (cancer specific stress, MDD history, anxiety disorder comorbidity, and homework compliance) of treatment outcome.
OUTLINE: Patients are randomized to 1 of 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •A current/prior cancer diagnosis
- •A principal diagnosis of major depressive disorder (MDD)
- •Able and willing to give informed consent
- •Have access to a computer with an internet connection at home
排除标准
- •History of bipolar affective disorder or psychosis
- •History of substance dependence in the past six months
- •Subnormal intellectual potential (intelligence quotient [IQ] below 80)
- •Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
- •Inability to read and write English
结局指标
主要结局
Change in Hamilton Rating Scale for Depression (HRSD)
时间窗: Week 0 to Week 8
The 17-item HRSD, modified to assess atypical symptoms, is a standard interview-administered measure of depressive symptom severity. The HRSD will be administered by study personnel supervised by the Principal Investigator.
次要结局
- Change in the Beck Depression Inventory (BDI-II)(Week 0 to week 8)
- Change in Patient Health Questionnaire-9 (PHQ-9)(Week 0 to week 8)
- Change in Generalized Anxiety Disorder-7 (GAD7)(Week 0 to week 8)
研究者
Barbara Andersen
Principal Investigator
Ohio State University Comprehensive Cancer Center