Reinventing Yourself With Multiple Sclerosis (MS): An Intervention Aimed at Improving Self-Efficacy, Coping, Psychological Well-being, and Quality of Life in MS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Multiple Sclerosis Self-Efficacy Scale
研究概览
简要总结
Given the knowledge that detriments in QOL, well-being, and participation are common in MS and attributable in a large part to individual, person-specific factors (e.g., self-efficacy), efforts to develop interventions aimed at addressing these factors is well needed and likely to have a significant impact. The proposed investigation will consist of two phases involving participant recruitment and data collection. Phase 1 will consist of a focus group aimed at identifying the unique needs of individuals with MS, and findings will be used to adapt the Reinventing Yourself after Spinal Cord Injury (SCI) intervention to Reinventing Yourself with MS. Phase 2 will consist of a randomized controlled trial (RCT) in which the feasibility and efficacy of the intervention in a new population can be examined.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Staff administering assessments will be blinded to group assignment (Intervention or control). Participants and group facilitators will be carefully instructed not to reveal group assignment to assessment administrators. Following each assessment, the blinded data collector will note whether unblinding occurred; this information will be entered into the study's web database. As an additional protection, blinded data collectors will have restricted access to the study database as some of the information that is collected would reveal group assignment (e.g., attendance of group members at sessions); this information will be entered into the database by unblinded staff. To track potential unblinding, blinded data collectors will respond to a two-item assessment of unblinding following each outcome assessment administered.
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 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).
排除标准
- •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
结局指标
主要结局
Multiple Sclerosis Self-Efficacy Scale
时间窗: Through study completion, an average of 6 months
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.
General Self-Efficacy Scale
时间窗: Through study completion, an average of 6 months
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
次要结局
- Health Status Questionnaire(Through study completion, an average of 6 months)
- Ryff Psychological Well-being Scales(Through study completion, an average of 6 months)
- Participation Assessment with Recombined Tools-Objective (PART-O)(Through study completion, an average of 6 months)
- Chicago Multiscale Depression Inventory(Through study completion, an average of 6 months)
- State Trait Anxiety Scale(Through study completion, an average of 6 months)
- Satisfaction with Life Scale(Through study completion, an average of 6 months)
- Connor-Davidson Resilience Scale(Through study completion, an average of 6 months)
- Benefit Finding in Multiple Sclerosis Scale(Through study completion, an average of 6 months)
- Cope Inventory(Through study completion, an average of 6 months)