Reinventing Yourself With Multiple Sclerosis (MS)
Reinventing Yourself With Multiple Sclerosis (MS): An Intervention Aimed at Improving Self-Efficacy, Coping, Psychological Well-being, and Quality of Life in MS
研究概览
详细说明
Multiple sclerosis (MS) is the leading cause of disability among middle-aged adults with recent estimates of nearly 1 million adults living with MS in the United States. Multiple sclerosis affects women anywhere from two to three times as often as men, with an age of diagnosis ranging from 20 to 50 years of age and a mean age of onset of 33 years of age. A host of physical, cognitive, and behavioral changes are common following the onset of this most common non-traumatic neurological disorder of middle adulthood, which greatly impacts quality of life (QOL), well-being, and everyday functioning and participation. Moreover, given that individuals are typically diagnosed with MS in the prime of their lives many are making important life decisions regarding work, family, etc. that are often hindered by their diagnosis. In fact, it has been found that men and women with MS aged 25-44, an age at which important early life decisions are often made, experienced more depression than their age-matched, healthy counterparts. Again, the course of the disease is variable and unpredictable with no known cure, which can lead to great uncertainty and difficulty in adjusting to a chronic and often, debilitating disease.
The overarching aim of the proposed investigation is to adapt the Reinventing Yourself intervention for use with MS and examine the feasibility and efficacy in increasing MS-specific and general self-efficacy and resilience, enhancing psychological well-being, fostering new ways of perceiving and managing one's illness in more proactive and positive ways, and improving participation in the community. To achieve this, the investigation has the following specific aims:
Specific Aim 1: Conduct a focus group with individuals with MS to identify unique needs of individuals with MS with regard to MS symptoms, barriers to well-being, QOL, and participation, and the role that person-specific factors (e.g., self-efficacy, resilience) and other psychological and social factors have contributed to success (or failure) in managing one's illness and living well.
Specific Aim 2: With the knowledge gained from Aim 1, modify the Reinventing Yourself intervention with the specific needs of MS, while maintaining the integrity and common principles of the Reinventing Yourself intervention.
Specific Aim 3: Conduct a RCT among individuals with MS to determine the feasibility and efficacy of the Reinventing Yourself with MS intervention.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Lauren Strober, PhD
- 电话号码：973-324-8459
- 邮箱：lstrober@kesslerfoundation.org
研究联系人备份
- 姓名：Amanda L Botticello, PhD
- 电话号码：973-243-6973
- 邮箱：abotticello@kesslerfoundation.org
学习地点
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New Jersey
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East Hanover、New Jersey、美国、07036
- 招聘中
- Kessler Foundation
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接触：
- Rachel Byrne, MA
- 电话号码：973-324-3567
- 邮箱：rbyrne@kesslerfoundation.org
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接触：
- Lauren Strober, PhD
- 电话号码：973.324.8459
- 邮箱：lstrober@kesslerfoundation.org
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of multiple sclerosis
- 18 years of age or older
- English-speaking
- Able to provide informed consent
- Access to the internet (if needed should the groups have to be conducted online due to pandemic circumstances that may limit to in-person meetings).
Exclusion Criteria:
- History of any other neurological illness (e.g. traumatic brain injury, epilepsy, dementia)
- Cognitive impairment that would affect my ability to fully participate in the group
- (For in-person group): Live beyond a reasonable commuting distance (50+ miles)
- Any other medical or psychological condition that, in the judgement of the investigators, prevents successful participation in the study
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Group Intervention
Participants will attend six weekly two-hour facilitator-led sessions that include didactic presentations of eight core skills and related experiential exercises with extensive group discussion.
These skills are presented in sequence over the course of the intervention so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex.
The culmination of developing these skills and participation in a peer group will assist individuals in increasing self-efficacy and overall QOL, well-being and participation.
Participants will complete follow-up assessment at 18- and 30-weeks post-intervention.
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A manualized group therapy to build self-efficacy among people living with multiple sclerosis.
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安慰剂比较：Placebo
Participants will receive no intervention throughout the course of the study; however, the participants will be tested at 18- and 30-weeks participation in the study.
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A manualized group therapy to build self-efficacy among people living with multiple sclerosis.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Multiple Sclerosis Self-Efficacy Scale
大体时间：Through study completion, an average of 6 months
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This scale measures self-efficacy related to the experience of MS symptoms and sequelae.
Scores range from 14-84.
Higher scores indicate greater self-efficacy.
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Through study completion, an average of 6 months
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General Self-Efficacy Scale
大体时间：Through study completion, an average of 6 months
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This scale measures one's general ability to control their behaviors and execute goals.
Scores range from 10-44.
Higher scores indicate greater self-efficacy
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Through study completion, an average of 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health Status Questionnaire
大体时间：Through study completion, an average of 6 months
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The Health Status Questionnaire consists for 8 scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.
Scores for each scale range from 0-100.
Higher scores indicate less disability.
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Through study completion, an average of 6 months
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Satisfaction with Life Scale
大体时间：Through study completion, an average of 6 months
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This scale measures global assessment of one's life on a scale of 5-35.
Higher scores indicate greater satisfaction.
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Through study completion, an average of 6 months
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Ryff Psychological Well-being Scales
大体时间：Through study completion, an average of 6 months
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This is a global assessment of quality of life.
Scores range from 14-84.
Higher scores indicate greater well-being.
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Through study completion, an average of 6 months
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Participation Assessment with Recombined Tools-Objective (PART-O)
大体时间：Through study completion, an average of 6 months
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PART-O measures three domains of participation: Productivity; Social Relations; and Out and About.
The short form consists of 17 items.
Items are scored on a scale from 0 to 5, with higher scores indicating greater participation
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Through study completion, an average of 6 months
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Chicago Multiscale Depression Inventory
大体时间：Through study completion, an average of 6 months
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This scale measures emotional distress among people with non-psychiatric medical illness across three scales: Mood, Evaluative, and Vegetative.
42 items are scored on a scale Higher scores indicate more negative affect.
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Through study completion, an average of 6 months
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State Trait Anxiety Scale
大体时间：Through study completion, an average of 6 months
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This scale measures momentary (state anxiety) and general (trait anxiety).
Scores range from 20-80.
Higher scores indicate greater anxiety
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Through study completion, an average of 6 months
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Connor-Davidson Resilience Scale
大体时间：Through study completion, an average of 6 months
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The Connor-Davidson Resilience scale (CD-RISC) measures stress-coping ability.
The CD-RISC comprises of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience.
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Through study completion, an average of 6 months
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Benefit Finding in Multiple Sclerosis Scale
大体时间：Through study completion, an average of 6 months
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This scale measures finding meaning and positive adjustment to MS. Scores range from 43-139.
Higher scores indicate greater benefit finding.
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Through study completion, an average of 6 months
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Cope Inventory
大体时间：Through study completion, an average of 6 months
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This instrument evaluates coping strategies.
28 items, scored from one ("I haven't been doing this at all") to four ("I've been doing this a lot"), exploring 14 strategies: active coping, planning, use of instrumental support, positive reframing, acceptance, use of emotional support, denial, venting, self-blame, humor, religion, self-distraction, substance use and behavioral disengagement.
Higher scores reflect a higher tendency to implement the corresponding coping strategies.
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Through study completion, an average of 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- R-1164-21
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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