- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555015
An Online Nurse-Led Purpose-Focused Group Program for Adult Women With Multiple Sclerosis: Effects on Meaning and Quality of Life
The Impact of a Nurse-Led Virtual Group Intervention on Purpose and Quality of Life in Adult Women With Multiple Sclerosis
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 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The intervention consists of six weekly synchronous group sessions delivered via a secure videoconferencing platform. Sessions are guided by a facilitator manual that standardizes structure, sequence, and fidelity expectations across all cohorts. Weekly sessions include the following components:
Opening Orientation (5-10 minutes):
Review of group norms, brief grounding, and a reflective prompt related to meaning, identity, or purpose.
Guided Reflective Dialogue (25-30 minutes):
Facilitated discussion encouraging participants to articulate interpretations of their lived experiences, explore evolving self-concepts, and consider how MS shapes or interacts with their sense of purpose. Facilitators support engagement without directing content.
Integrative Meaning Exercise (15-20 minutes):
A structured activity (e.g., brief journaling, values clarification task, narrative framing, or identification of meaningful actions) designed to encourage internalization of insights. Exercises are consistent across cohorts but do not require participants to share personal details unless they choose.
- Closing Synthesis (5 minutes):
Participants reflect on key takeaways and identify one meaning-related intention for the coming week. No assignments are collected as data.
This structure is consistent across all sessions; however, thematic emphasis naturally evolves as participants deepen their engagement with reflective processes. Facilitators complete fidelity checklists each week.
No counseling, psychotherapy, or clinical decision-making occurs within the sessions. The facilitator's role is strictly reflective, supportive, and protocol guided.
Participants complete electronic surveys at three time points. Measures include:
- Meaning in Life Questionnaire-Search (MLQ-S)
- Meaning in Life Questionnaire-Presence (MLQ-P)
- MSQOL-29 These instruments were selected based on reliability, chronic illness relevance, and suitability for repeated assessments over a short intervention period. Data are linked to a unique study identifier and stored in encrypted institutional systems.
Women comprise the majority of adults living with MS and frequently describe meaning-related disruptions following diagnosis, including changes in identity, purpose, and role engagement. Examining meaning and quality-of-life processes within a women-focused cohort provides foundational evidence for future expansions to more diverse populations and allows exploratory examination of meaning-making patterns within a demographic known to encounter distinct illness experiences.
This is a minimal-risk behavioral study. The primary potential risks involve psychological discomfort during reflective dialogue. Participants may pause or decline participation in any exercise. Privacy expectations and strategies to maintain confidentiality in a virtual group setting are reviewed during consent and reiterated at session onset. Because group participants can see one another, confidentiality among members cannot be guaranteed; however, participants may use alternative names if preferred.
Study data are de-identified and stored in compliance with institutional and regulatory requirements.
Descriptive statistics will summarize demographic characteristics and baseline distributions. Repeated-measures ANOVA or linear mixed models will evaluate change over time for each outcome. Model assumptions will be assessed, and corrective methods (e.g., Greenhouse-Geisser adjustment, mixed-effects modeling) will be applied as needed. Effect sizes will be calculated to estimate magnitude of change. Missing data will be evaluated for patterns, and appropriate handling strategies (e.g., model-based approaches) will be used.
This study provides preliminary evaluation of a theoretically anchored, nurse-facilitated behavioral intervention centered on meaning-making among women with MS. Findings will guide protocol refinement, inform sample size estimates for future trials, and contribute to the development of purpose-building interventions within nursing and chronic illness research.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lisa Kelly
- Phone Number: 254-368-7638
- Email: lkelly5@twu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- women
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nurse-Led Virtual Purpose-Building Intervention
|
The Nurse-Led Virtual Purpose-Building Intervention is a six-week, synchronous behavioral program delivered in small groups through a secure videoconferencing platform.
Sessions are facilitated by a registered nurse trained in the study protocol.
Each weekly session lasts 60 minutes and follows a standardized structure that includes: (1) an opening reflective prompt or grounding exercise, (2) guided group dialogue focused on meaning, identity, and purpose in the context of living with Multiple Sclerosis, (3) a brief integrative activity such as journaling or values-based reflection, and (4) a closing synthesis.
The intervention emphasizes person-centered exploration, reflective engagement, and meaning-making rather than clinical counseling or symptom management.
No medical treatments, diagnostic procedures, or therapeutic techniques are used.
Fidelity to session structure is supported through a facilitator manual and weekly documentation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Search for Meaning (Meaning in Life Questionnaire - Search Subscale)
Time Frame: 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.
|
Baseline, Week 3, Week 6
|
|
Change in Quality of Life (Multiple Sclerosis Quality of Life-29 Scale)
Time Frame: 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.
|
Baseline, Week 3, Week 6
|
|
Change in Presence of Meaning (Meaning in Life Questionnaire - Presence Subscale)
Time Frame: 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.
|
Baseline, Week 3, Week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Chanam Shin, PhD, Texas Woman's University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY2026-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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