The Impact of a Nurse-Led Virtual Group Intervention on Purpose and Quality of Life in Adult Women With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Search for Meaning (Meaning in Life Questionnaire - Search Subscale)
研究概览
简要总结
The goal of this study is to learn how a six-week, nurse-led virtual group program may affect meaning in life and quality of life in adult women living with Multiple Sclerosis (MS). Many people with MS describe changes in identity, purpose, and daily life. This study will help researchers understand whether a structured group program can support women as they explore meaning and purpose while living with MS.
The main questions this study aims to answer are:
- How does the program affect how participants search for meaning in life?
- How does it affect their sense of life purpose or direction?
- How does it affect their overall quality of life?
This study uses a single-group design. All participants will take part in the six-week virtual group program. The program is led by a registered nurse and focuses on guided reflection, values exploration, and group discussion.
Participants will:
- Attend one virtual group session for one hour each week for six weeks
- Take part in guided discussions and reflection exercises
- Complete three online surveys: one before the program begins, one at Week 3, and one after Week 6
- Use a computer, tablet, or phone to join all virtual sessions
The surveys will ask about:
- How participants search for meaning in their lives
- How much purpose and direction they feel
- Their physical and emotional quality of life
There are no medications, invasive procedures, or in-person visits in this study.
详细描述
Living with Multiple Sclerosis (MS) involves complex psychological and existential challenges that may influence well-being, identity, and perceived life direction. PURPOSE-MS is a structured behavioral intervention designed to support meaning-making and purpose exploration among adult women with MS. This study uses a repeated-measures, single-group design to evaluate within-participant change across meaning-related constructs and quality of life over a six-week intervention period.
The study integrates two complementary frameworks. The quantitative portion is grounded in the Purpose and Meaning in Life tradition, which conceptualizes meaning as both an evaluative state (Presence of Meaning) and an active cognitive process (Search for Meaning). These constructs serve as the measurable variables for hypothesis testing.
Parse's Human Becoming Theory provides the philosophical structure for how the intervention is facilitated. Consistent with Parse, the intervention prioritizes participants' interpretations, reflective engagement, and the co-creation of meaning within a relational environment. Parse guides facilitator posture and session flow but does not function as the causal mechanism under evaluation.
A single-arm, quasi-experimental repeated-measures design is used. Participants complete standardized assessments at baseline, midpoint, and post-intervention. This design allows examination of temporal change and feasibility ahead of future controlled trials. The analytic strategy focuses on patterns of change rather than group comparisons.
Informed consent is obtained electronically prior to participation. Eligible individuals receive a secure link to the consent form and meet synchronously with study personnel to review the study purpose, expectations, risks, confidentiality protections, and voluntary nature of participation. Participants have the opportunity to ask questions before signing electronically. They are informed that they may withdraw at any time without penalty, may skip any activity, and that data will be de-identified and stored securely. Consent is documented within the institution's approved electronic record-keeping system. No identifiable health information is collected beyond contact information needed for study communication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •over the age of 18
- •a diagnosis of Multiple Sclerosis (Primary Progressive, Relapsing-Remitting, Secondary Progressive)
- •access to a device with internet capability as well as audio and video functions
- •comfortable reading, writing, and participating in group discussions in English
排除标准
- •currently enrolled (or have been enrolled within the last 4 weeks) of any similar group based intervention therapy (logotherapy, Acceptance and Commitment Therapy, or Cognitive Behavioral Therapy)
研究组 & 干预措施
Nurse-Led Virtual Purpose-Building Intervention
干预措施: Nurse-Led Purpose-Building Intervention (Behavioral)
结局指标
主要结局
Change in Search for Meaning (Meaning in Life Questionnaire - Search Subscale)
时间窗: Baseline, Week 3, Week 6
The Search for Meaning subscale of the Meaning in Life Questionnaire (MLQ-S) assesses the degree to which individuals are actively seeking purpose or meaning in their lives. Scores range from 5 to 35, with higher scores indicating a greater search for meaning. The outcome is the change in MLQ-S scores from Baseline to Week 3 and Week 6.
Change in Quality of Life (Multiple Sclerosis Quality of Life-29 Scale)
时间窗: Baseline, Week 3, Week 6
Quality of life will be assessed using the Multiple Sclerosis Quality of Life-29 (MSQOL-29), which generates composite scores for physical and mental well-being. Subscale scores are standardized from 0 to 100, with higher scores indicating better quality of life. The outcome is the change in MSQOL-29 composite scores from Baseline to Week 3 and Week 6.
Change in Presence of Meaning (Meaning in Life Questionnaire - Presence Subscale)
时间窗: Baseline, Week 3, Week 6
The Presence of Meaning subscale of the Meaning in Life Questionnaire (MLQ-P) measures the extent to which individuals perceive their lives as meaningful. Scores range from 5 to 35, with higher scores indicating greater perceived meaning. The outcome is the change in MLQ-P scores from Baseline to Week 3 and Week 6.
次要结局
- Change in Search for Meaning (Meaning in Life Questionnaire - Search Subscale)(Baseline, Week 3, Week 6)
- Change in Presence of Meaning (Meaning in Life Questionnaire - Presence Subscale)(Baseline, Week 3, Week 6)
研究者
Lisa Kelly
Principal Investigator
Texas Woman's University
