Psychosocial Treatment of Depression in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17).
研究概览
简要总结
The purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease (PD).
详细描述
CBT is a specific type of treatment that has been shown to be as helpful in treating depression as medications for depression. CBT focuses on thoughts, feelings, and behaviors. It focuses on the here and now, rather than the past. CBT offers concrete strategies and skills for coping with depression, PD, and other life problems. Previous research leads us to believe that this type of therapy may help people with PD cope with their 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In addition to the DSM-IV diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:
- •Written informed consent.
- •Subjects with a primary diagnosis of PD who also currently meet DSM-IV criteria for MDD
- •Subjects must be stable on their anti-Parkinson treatment, as defined by no medication changes over the past 6 weeks
- •Subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
- •Men or women 40-80 years of age
- •HAMD-17 scores > 14 at screen visit
- •Score of 25 or greater on the Mini-Mental Status Examination
- •Willing to come to MGH for screening and study participation
排除标准
- •Patients meeting any of the following criteria are to be excluded from the study:
- •Subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
- •Patients who would not be appropriate for a delayed CBT control due to the severity of their depression based on clinical judgment as well as HAMD-17 scores > 28
- •The following DSM-IV diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) MDD with psychotic features
- •Subjects who meet DSM-IV criteria for dementia
- •Severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
- •Subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed
结局指标
主要结局
Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17).
时间窗: screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24
次要结局
未报告次要终点
研究者
Amy Farabaugh, PhD
Director, Psychotherapy Research, Depression Clinical & Research Program
Massachusetts General Hospital