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临床试验/NCT00601055
NCT00601055已完成不适用

Treating Older Patients With Major Depression and Severe COPD

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2008年2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
101
试验地点
2
主要终点
Depressive symptoms

研究概览

简要总结

This study will evaluate the effectiveness of problem-solving therapy combined with treatment adherence procedures in treating older people with major depression and chronic obstructive pulmonary disease.

详细描述

Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Depression often occurs in the presence of one or more other disorders. For example, depression is reported to be at a higher rate in people with chronic obstructive pulmonary disease (COPD) than in the general population. COPD is a disease in which the lungs are damaged, making it difficult to breathe. Symptoms most commonly include chronic coughing and shortness of breath. A primary cause of COPD is cigarette smoking. Following a prescribed treatment plan is important for managing COPD. Unfortunately, people with COPD often do not adhere to their treatment plans. Being depressed makes adherence even more difficult. This study will evaluate the effectiveness of problem-solving therapy integrated with adherence-enhanced procedures (PSA) in treating older people with major depression and COPD.

Participants in this open label study will be randomly assigned to one of two groups: PSA or PID-C. In PSA, a therapist will teach participants problem-solving strategies focusing on treatment adherence, depressive symptoms, and disability. Participants will learn behaviors and solutions to help cope with these problems. In PID-C, a therapist will teach participants to identify obstacles to treatment adherence and to discover ways to overcome them. The treatment sessions for both groups will be initiated at the inpatient Pulmonary Unit of Burke Rehabilitation Hospital and will continue in the participants' homes. All participants will receive two treatment sessions during hospitalization, eight weekly sessions following discharge, and four monthly sessions after that. While hospitalized at Burke, participants will also undergo an assessment interview for 1.5 hours and another interview for 20 minutes 2 weeks following the initial assessment. Interviews lasting 1.5 hours will also occur in the homes of the participants at Weeks 10, 14, and 26 after discharge from Burke. All assessments will focus on depression severity, level of general functioning, and COPD treatment adherence.

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
50 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Meets American Thoracic Society criteria for COPD
  • •Meets DSM-IV criteria for unipolar major depression
  • •Scores greater than 19 on 24-item Hamilton Depression Rating Scale
  • •Fluency in English sufficient for comprehending the questionnaires of the study and for understanding the therapists

排除标准

  • •Unable to give informed consent
  • •Experiencing suicidal thoughts
  • •History of or currently meets DSM-IV criteria for the following Axis I disorders: psychotic depression, psychotic disorder, bipolar disorder, dysthymic disorder, obsessive compulsive disorder, or current substance abuse
  • •Meets DSM-IV criteria for Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV)
  • •Scores less than 24 on Mini-Mental State Exam (MMSE) or meets DSM-IV criteria for dementia
  • •Certain illnesses (e.g., untreated thyroid or adrenal disease, pancreatic cancer, lymphoma)
  • •Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
  • •Current involvement in psychotherapy
  • •Requires nursing home placement after discharge

研究组 & 干预措施

Problem Solving-Rx Adherence (PSA)

Experimental

Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PSA).

干预措施: Problem Solving-Rx Adherence (PSA) (Behavioral)

PID-C

Active Comparator

Participants will receive adherence-enhanced (PID-C) procedures, a treatment mobilizing patients to participate in their care.

干预措施: PID-C (Behavioral)

结局指标

主要结局

Depressive symptoms

时间窗: Measured at week 26

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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