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临床试验/NCT02010554
NCT02010554已完成不适用

Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS

University of Missouri, Kansas City2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年12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
40
试验地点
2
主要终点
Adherence Treatment Survey

研究概览

简要总结

Between 15-20% of MS patients decide not to initiate disease modifying therapies after being diagnosed with MS. For this study, we will develop a telephone-based talk therapy intervention and then conduct a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control condition. We hypothesize that patients undergoing phone therapy will be more likely to indicate they are interested in initiating disease modifying medications than patients given brief education and treatment as usual.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •Diagnosis of relapsing remitting MS based on established guidelines
  • •Not taking recommended therapy
  • •Provider recommendation for DMT use
  • •At least 18 years of age
  • •Access to a telephone
  • •English speaking

排除标准

  • 未提供

研究组 & 干预措施

Brief Education

Active Comparator

Patients receive a brief educational packet along with treatment as usual

干预措施: Brief Education (Behavioral)

MI-CBT Treatment

Experimental

Patients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet.

干预措施: Brief Education (Behavioral)

MI-CBT Treatment

Experimental

Patients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet.

干预措施: Motivational Interviewing-Cognitive Behavioral Therapy (Behavioral)

结局指标

主要结局

Adherence Treatment Survey

时间窗: 10 weeks after enrollment

Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.

次要结局

  • Adherence Treatment Survey(5 weeks after enrollment)
  • Adherence Treatment Survey(10 weeks after enrollment)

研究者

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

Jared Bruce

Associate Professor of Psychology

University of Missouri, Kansas City

研究点 (2)

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