A Guided Cognitive-Behavioral Self-Help Treatment for Depression in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- The Hamilton Depression Rating Scale
研究概览
简要总结
The purpose of this project is to develop and pilot-test a guided cognitive-behavioral self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The manual will be revised based on participant feedback. Several feasibility measures regarding the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness, adherence) will also be assessed. Moreover, preliminary estimates of effect size for this guided self-help program will be calculated and used in future research. We hypothesize that people with PD will report decreases in depression, anxiety, and negative thoughts and improvements in quality life and sleep and that caregivers will report decreases in burden after participating in the guided self-help program
详细描述
To our knowledge, Cognitive-Behavioral self-help interventions remain unexplored for depression in PD to date. The results of this study will be used to support future treatment development efforts for depression and other psychiatric complications in PD that may improve the access to and quality of mental health care in this medical population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist
- •Clinically significant depression as determined by study staff
- •35-85 years old
- •Stable medication regimen ≥ 6 weeks
- •No change in mental health treatment in past 2 months _
排除标准
- •Severe depressive symptoms
- •Suicidal plans or intent
- •Significant cognitive impairment
- •Significant motor fluctuations (i.e., ≥ 50% of the day)
- •Unstable medical conditions
- •Receiving CBT elsewhere
研究组 & 干预措施
Guided Cognitive-Behavioral Self-Help
All participants will receive the experimental intervention: Guided Cognitive-Behavioral Self-Help. The 10 patient treatment modules will incorporate exercise, behavioral activation, thought monitoring and restructuring, relaxation training, worry control, and sleep hygiene. The four caregiver educational modules will provide caregivers with the skills needed to facilitate patients' practice of treatment techniques learned in session. For example, caregivers will be taught to help patients identify negative thoughts and replace them with more balanced alternatives and will be given tools to assist patients complete therapy goals (i.e., exercise, socializing).
干预措施: Guided Cognitive-Behavioral Self-Help (Behavioral)
结局指标
主要结局
The Hamilton Depression Rating Scale
时间窗: 14 weeks
A clinician-administered rating scale for depression
次要结局
- Inference Questionnaire(14 weeks)
- Beck Depression Inventory(14 weeks)
- Insomnia Severity Index(14 weeks)
- Medical Outcomes Short Form(14 weeks)
- Clinical Global Impression-Improvement Scale(14 weeks)
- Feasibility and adherence measures(10 weeks)
- Hamilton Anxiety Rating Scale(14 weeks)
- Caregiver Distress Scale(14 weeks)
研究者
Roseanne D Dobkin, PhD
Associate Professor of Psychiatry
Rutgers, The State University of New Jersey