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Multiple SclerosisNCT07555015

An Online Nurse-Led Purpose-Focused Group Program for Adult Women With Multiple Sclerosis: Effects on Meaning and Quality of Life

A study testing Nurse-Led Purpose-Building Intervention in people with Multiple Sclerosis, run by Texas Woman's University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Multiple Sclerosis
What is being tested?
Nurse-Led Purpose-Building Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
14 Jul 2026to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Woman's University

    Denton, Texas, 76204

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.

Read the 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:

  1. Opening Orientation (5-10 minutes): Review of group norms, brief grounding, and a reflective prompt related to meaning, identity, or purpose.
  2. 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.
  3. 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.
  4. 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.

Being tested
Nurse-Led Purpose-Building Intervention
Keywords
Multiple Sclerosis, Quality of Life, Meaning in Life, Nurse-led behavioral intervention, Purpose-building intervention, Meaning-centered intervention, virtual group intervention, Nurse-guided, Psychological adaptations, Purpose in life
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurse-Led Purpose-Building InterventionBehavioural

    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.

Study groups in NCT07555015
Study groupRoleWhat they receive
Nurse-Led Virtual Purpose-Building InterventionExperimentalNot described
Receives: Behavioral: Nurse-Led Purpose-Building Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Quality of Life (Multiple Sclerosis Quality of Life-29 Scale)

    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.

    Measured: Baseline, Week 3, Week 6

Secondary outcomes (2)
  1. Change in Search for Meaning (Meaning in Life Questionnaire - Search Subscale)

    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.

    Measured: Baseline, Week 3, Week 6

  2. Change in Presence of Meaning (Meaning in Life Questionnaire - Presence Subscale)

    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.

    Measured: Baseline, Week 3, Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2026
  2. Study start14 Jul 2026
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555015
Sponsor's protocol ID
IRB-FY2026-50
Status last verified
Apr 2026
First submitted
21 Apr 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to the small sample size and risk of re-identification. However, de-identified aggregate results will be shared publicly through publications and conference presentations.

Questions about this trial

What is this clinical trial studying?

A study testing Nurse-Led Purpose-Building Intervention in people with Multiple Sclerosis, run by Texas Woman's University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality of Life (Multiple Sclerosis Quality of Life-29 Scale) (time frame: Baseline, Week 3, Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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