Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS
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
Patients receive a brief educational packet along with treatment as usual
干预措施: Brief Education (Behavioral)
MI-CBT Treatment
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
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
Jared Bruce
Associate Professor of Psychology
University of Missouri, Kansas City
