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临床试验/NCT00947232
NCT00947232已完成不适用

The Effectiveness of Physical Activity for Major Depression in People Aging With Multiple Sclerosis or Spinal Cord Injury

University of Washington1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2009年10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
123
试验地点
1
主要终点
HAM-D

研究概览

简要总结

This study compares two approaches to helping people who are aging with MS or SCI and are experiencing depressed mood to become more physically active. The study is carried out entirely by telephone. There is no need to travel and participants may reside anywhere within the United States. We will examine the effects of the intervention on overall physical activity, mood, pain, fatigue and general health. Participants will complete surveys over the phone throughout the study and wear an activity monitor 3 times. The study is 6 months in length and participants may receive up to $120 for their time and effort.

详细描述

People aging with disabilities such as spinal cord injury (SCI) or multiple sclerosis (MS) report high rates of major depression. Depression frequently adds to the disabilities and suffering in these populations. Few definitive studies of depression treatments have been done in people with MS and none in SCI. There are several reasons to explore novel treatments for major depression in these groups. First, standard treatments, such as antidepressant medications, may not be as effective in people with neurological disabilities. Next, people with physical disabilities tend to be inactive. Lack of physical activity has been positively correlated with higher levels of depression. Longitudinal data and treatment trials suggest that increased physical activity is related to improved mood. Controlled trials show that increased exercise and physical activity can be effective treatments for major depression in nondisabled older adults. Previous research by the investigators' group suggests that people with MS are quite interested in exercise and that exercise is a safe and effective treatment for depression in younger, less disabled people with MS. Exercise may have widespread benefits for people with MS or SCI. Finally, exercise or increased physical activity represents a low cost, non-stigmatizing, highly accessible potential treatment for depression in people with physical disabilities. In this study the investigators will determine whether a relatively brief telephone-based intervention to promote physical activity is an effective treatment for major depression in people aging with MS or SCI. The investigators define "aging" as chronological age greater than 45 years old.

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

入选标准

  • •aged at least 45 years old
  • •self-report diagnosis of MS or SCI
  • •meeting SCID requirements for Major Depressive Disorder (MDD) or dysthymia
  • •MS: EDSS between 4.0 and 8.0
  • •SCI: ASIA A-D injury level at or below C4 and they have upper extremity function sufficient to propel a manual wheelchair
  • •meeting PHQ-9 measure cut-off for depression by scoring more than 10 on the measure
  • •currently inactive (exercising less than 150 minutes per week)
  • •response form received from participants' doctor declaring exercise safe for the subject.

排除标准

  • •significant cognitive impairment
  • •pressure ulcers on sitting surfaces (or another condition that precludes sitting
  • •significant obesity (>160% of ideal body weight)
  • •significant risk factors for beginning moderate physical activity measured with the PAR-Q
  • •response form received from participants' doctor declaring exercise unsafe for the subject
  • •a self-reported history of significant Uthoff's effect for those with MS
  • •psychiatric contraindications such as bipolar disorder, psychosis, active suicidal ideation with intent or plan, or current alcohol or drug dependence. We will include people who remain depressed but are on stable doses of antidepressant medications.

研究组 & 干预措施

Motivational interviewing

Experimental

Motivational interviewing for people aging with multiple sclerosis or spinal cord injury to increase physical activity and decrease depression.

干预措施: Motivational interviewing (Behavioral)

Education

Active Comparator

Education about physical activity for people aging with multiple sclerosis or spinal cord injury to decrease depression.

干预措施: Education (Behavioral)

结局指标

主要结局

HAM-D

时间窗: Baseline, weeks 4, 6, 8, 12, and 24

17-item interview based depression severity measure

次要结局

  • International Physical Activity Questionnaire(Baseline, weeks 4, 6, 8, 12, and 24)

研究者

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

Charles Bombardier

Professor

University of Washington

研究点 (1)

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