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Reinventing Yourself With Multiple Sclerosis (MS)

12. října 2022 aktualizováno: Kessler Foundation

Reinventing Yourself With Multiple Sclerosis (MS): An Intervention Aimed at Improving Self-Efficacy, Coping, Psychological Well-being, and Quality of Life in MS

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

48

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: Reinvention with MS
A manualized group therapy to build self-efficacy among people living with multiple sclerosis.
Komparátor placeba: 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.
Behaviorální: Reinvention with MS
A manualized group therapy to build self-efficacy among people living with multiple sclerosis.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Multiple Sclerosis Self-Efficacy Scale
Časové okno: 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.
Through study completion, an average of 6 months
General Self-Efficacy Scale
Časové okno: 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
Through study completion, an average of 6 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Health Status Questionnaire
Časové okno: Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
Satisfaction with Life Scale
Časové okno: Through study completion, an average of 6 months
This scale measures global assessment of one's life on a scale of 5-35. Higher scores indicate greater satisfaction.
Through study completion, an average of 6 months
Ryff Psychological Well-being Scales
Časové okno: Through study completion, an average of 6 months
This is a global assessment of quality of life. Scores range from 14-84. Higher scores indicate greater well-being.
Through study completion, an average of 6 months
Participation Assessment with Recombined Tools-Objective (PART-O)
Časové okno: Through study completion, an average of 6 months
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
Through study completion, an average of 6 months
Chicago Multiscale Depression Inventory
Časové okno: Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
State Trait Anxiety Scale
Časové okno: Through study completion, an average of 6 months
This scale measures momentary (state anxiety) and general (trait anxiety). Scores range from 20-80. Higher scores indicate greater anxiety
Through study completion, an average of 6 months
Connor-Davidson Resilience Scale
Časové okno: Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
Benefit Finding in Multiple Sclerosis Scale
Časové okno: Through study completion, an average of 6 months
This scale measures finding meaning and positive adjustment to MS. Scores range from 43-139. Higher scores indicate greater benefit finding.
Through study completion, an average of 6 months
Cope Inventory
Časové okno: Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Kessler Foundation

Spolupracovníci

University of Minnesota
Craig Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. srpna 2022

Primární dokončení (Očekávaný)

30. září 2024

Dokončení studie (Očekávaný)

30. září 2024

Termíny zápisu do studia

První předloženo

15. listopadu 2021

První předloženo, které splnilo kritéria kontroly kvality

4. ledna 2022

První zveřejněno (Aktuální)

18. ledna 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. října 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. října 2022

Naposledy ověřeno

1. října 2022

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • R-1164-21

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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