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临床试验/NCT01694628
NCT01694628已完成不适用

Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression

University of Washington1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Depressive Symptoms

研究概览

简要总结

The purpose of this study in patients with advanced COPD and depression is twofold:

  1. Determine the feasibility and acceptability of a 6-session e-counseling intervention
  2. Determine the efficacy of the e-counseling intervention on depressive symptoms

We hypothesize that patients who participate in e-counseling will have improved depressive symptoms compared to patients receiving usual care at 8 weeks.

详细描述

Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the US. Although COPD is mostly preventable, there is no cure. Thus, care of patients with COPD is primarily focused on symptom palliation with the goal of improving quality of life for both patients and their families. These goals are highly consistent with core principles of palliative care. Dyspnea is the most distressing symptom for patients. Even optimal disease-directed treatment provides only partial relief from dyspnea. Depression is consistently associated with worse dyspnea, but the mechanisms underlying this relationship are poorly understood. Since existing treatment for dyspnea has only limited success and there is evidence that treating depression alleviates pain, we propose that by improving mood, we may be more successful in alleviating dyspnea. Psychosocial-behavioral therapy (PBT) which is focused on increasing pleasant events and improving problem solving skills has been shown to have immediate and sustained effects on depressive symptoms in patients with dementia and post-stroke holds tremendous promise for efficacy in advanced COPD. Testing the use of novel technologies to provide efficacious interventions such as PBT to patients with advanced disease is critical for translational palliative care research

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 (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •COPD (FEV1/FVC < 70% & FEV1 <80%; current or past smoking >10pack-years)
  • •Depressed (PHQ-9 >=10)
  • •Ability to speak, read and write English
  • •Willingness to use computer or study-issued tablet device

排除标准

  • •Current non-nicotine substance abuse or dependence
  • •Psychotic disorder
  • •Active suicide ideation with intent and plan
  • •Alzheimer's/dementia
  • •Currently receiving any psychotherapy

研究组 & 干预措施

CLIMB (COPD Lifestyle, Mood, and Behavior)

Experimental

Counseling sessions for COPD and depression

干预措施: CLIMB (COPD Lifestyle, Mood, and Behavior) (Behavioral)

Control

No Intervention

Usual Care

结局指标

主要结局

Depressive Symptoms

时间窗: 8 weeks

Personal Health Questionnaire-9

次要结局

  • Fatigue(8 weeks)
  • Quality of Life(8 weeks)
  • Anxiety(8 weeks)
  • Physical Activity(8 weeks)
  • Dyspnea Intensity and Distress(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lynn Foster Reinke

Clinical Associate Professor

University of Washington

研究点 (1)

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