Telehealth Psychotherapy for Depression in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Anxiety and Related Disorders Interview Schedule for DSM-5
研究概览
简要总结
Depression is a prevalent non-motor symptom of Parkinson's disease (PD). Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for depression in PD. CBT is usually administered in-person in weekly sessions, but PD motor disability, stigma, and transportation issues may prevent attending such therapy sessions. CBT administered via live videoconference technology may allow the treatment of depression, while circumventing the barriers that deter those with PD from seeking psychological services. The investigators propose that videoconference CBT will improve mood in individuals with PD who have depression.
详细描述
The investigators plan to conduct a randomized control trial with 12 participants. Six (PD-early) will receive three assessments: baseline, immediately post-treatment (post1), and 6 weeks after treatment (post2). The other six (PD-waitlist) will have an additional assessment (Baseline 2; 12 weeks after Baseline 1) to examine practice effects before beginning treatment, and then will have the post1 and post2 assessments (four assessments).
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
- Single (Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease (PD), any subtype
- •Depression
- •Internet access and a webcam
- •For psychotropic and dopaminergic medications, participants may enroll only if they are stable for at least 6 weeks and 2 weeks, respectively, before beginning the study
- •The investigators will enroll only depressed individuals with PD who are not already receiving or are willing to stop other ongoing psychotherapy before beginning this treatment study
排除标准
- •Serious chronic medical or neurological illness, other than PD
- •History of traumatic brain injury
- •Mental retardation
- •Current or recent (past 90 days) history of substance abuse or drug dependence, with the exception of nicotine, marijuana, and caffeine
- •Active suicidal or homicidal ideation or intent
- •Current DSM-5 diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or substance/medication-induced disorder
- •Previous experience with an adequate trial of cognitive-behavioral therapy (8 sessions within the past 5 years
- •Concurrent psychosocial treatment (i.e., therapy) focused on depression, anxiety, or other related disorders, or are not willing to refrain from initiating additional therapy during the study
- •Concurrent psychotropic medications if not stabilized or not willing to maintain a stable dosage of psychotropic medications, such as medications for depression or anxiety, during study participation
研究组 & 干预措施
Cognitive-behavioral therapy (CBT)
Individuals in the CBT arm are expected to participate in a phone screen + baseline phase (one assessment) + 10-12 weeks of CBT intervention + post-intervention assessment + 6 week follow-up assessment.
干预措施: Cognitive-behavioral therapy (CBT) (Behavioral)
Waitlist Control
Individuals in the Waitlist Control arm are expected to participate in a phone screen + baseline phase (two assessments, 12 weeks apart) + 10-12 weeks of CBT intervention + post-intervention assessment + 6 week follow-up assessment.
干预措施: Cognitive-behavioral therapy (CBT) (Behavioral)
结局指标
主要结局
Anxiety and Related Disorders Interview Schedule for DSM-5
时间窗: Change in diagnosis of depression from baseline to post-treatment (approximately 12 weeks after baseline) and 6-week follow-up.
Semi-structured diagnostic interview for assessment of mood and related disorders.
次要结局
未报告次要终点
研究者
Alice Cronin-Golomb
Director, Vision & Cognition Laboratory
Boston University Charles River Campus