Brief CBT for the Treatment of Depression During Inpatient Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Montgomery-Ashberg Depression Scale (MADRS)
研究概览
简要总结
Moderately to severely depressed subjects will be randomized to the "Control Group," who will receive care as usual, or the "CBT Group," who will receive care as usual in addition to the manualized course of Cognitive Behavioral Therapy (CBT).
详细描述
Participants assigned to the CBT condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy. If a patient is randomly assigned to the enhanced CBT group, manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.The training M.D., who is a treating physician on HCC-10, will also intermittently and randomly observe the CBT sessions to ensure the manual properly is being followed. Although the control condition may contain elements of CBT as per the clinician completing the therapy, it is not manualized, does not include specific exercises to be completed between sessions, and is not a course that builds upon skills from the previous day, as in the CBT condition. Participants assigned to the control condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy.
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
- •Diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria on initial assessment on the unit.
- •Demonstrates at least moderate degree of depressive symptoms on MADRS, HAM-D, and CGI-S.
- •Provides written informed consent.
排除标准
- •A mental illness other than depression that is the primary cause of treatment, as determined by the Principal Investigator.
- •A cognitive or neurologic disorder that inhibits ability to engage in CBT.
研究组 & 干预措施
Control Condition
usual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy.
干预措施: Usual Standard of Care (Behavioral)
CBT Condition
If a patient is randomly assigned to the enhanced CBT group, they will participate in manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.
干预措施: Usual Standard of Care (Behavioral)
CBT Condition
If a patient is randomly assigned to the enhanced CBT group, they will participate in manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.
干预措施: Cognitive Behavioral Therapy Condition (CBT) (Behavioral)
结局指标
主要结局
Montgomery-Ashberg Depression Scale (MADRS)
时间窗: 15 Minutes
A ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. The ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe). It is designed to be sensitive to change, so is often the scale of choice when interventions, such as psychotherapies, electroconvulsive therapy, or drug trials, are being studied.
Hamilton Rating Scale for Depression (HAM-D)
时间窗: 20 Minutes
Clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness.
Clinical Global Impression Severity Scale (CGI-S)
时间窗: 20 Minutes
Single-item rating scale of the clinician's assessment of the global severity of depressive symptoms in relation to the clinician's total experience with depressed patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
次要结局
未报告次要终点