- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05195320
Reinventing Yourself With Multiple Sclerosis (MS)
Reinventing Yourself With Multiple Sclerosis (MS): An Intervention Aimed at Improving Self-Efficacy, Coping, Psychological Well-being, and Quality of Life in MS
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Lauren Strober, PhD
- Numer telefonu: 973-324-8459
- E-mail: lstrober@kesslerfoundation.org
Kopia zapasowa kontaktu do badania
- Nazwa: Amanda L Botticello, PhD
- Numer telefonu: 973-243-6973
- E-mail: abotticello@kesslerfoundation.org
Lokalizacje studiów
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New Jersey
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East Hanover, New Jersey, Stany Zjednoczone, 07036
- Rekrutacyjny
- Kessler Foundation
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Kontakt:
- Rachel Byrne, MA
- Numer telefonu: 973-324-3567
- E-mail: rbyrne@kesslerfoundation.org
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Kontakt:
- Lauren Strober, PhD
- Numer telefonu: 973.324.8459
- E-mail: lstrober@kesslerfoundation.org
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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A manualized group therapy to build self-efficacy among people living with multiple sclerosis.
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Komparator placebo: 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.
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A manualized group therapy to build self-efficacy among people living with multiple sclerosis.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Multiple Sclerosis Self-Efficacy Scale
Ramy czasowe: Through study completion, an average of 6 months
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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.
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Through study completion, an average of 6 months
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General Self-Efficacy Scale
Ramy czasowe: Through study completion, an average of 6 months
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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
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Through study completion, an average of 6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Health Status Questionnaire
Ramy czasowe: Through study completion, an average of 6 months
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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.
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Through study completion, an average of 6 months
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Satisfaction with Life Scale
Ramy czasowe: Through study completion, an average of 6 months
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This scale measures global assessment of one's life on a scale of 5-35.
Higher scores indicate greater satisfaction.
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Through study completion, an average of 6 months
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Ryff Psychological Well-being Scales
Ramy czasowe: Through study completion, an average of 6 months
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This is a global assessment of quality of life.
Scores range from 14-84.
Higher scores indicate greater well-being.
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Through study completion, an average of 6 months
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Participation Assessment with Recombined Tools-Objective (PART-O)
Ramy czasowe: Through study completion, an average of 6 months
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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
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Through study completion, an average of 6 months
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Chicago Multiscale Depression Inventory
Ramy czasowe: Through study completion, an average of 6 months
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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.
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Through study completion, an average of 6 months
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State Trait Anxiety Scale
Ramy czasowe: Through study completion, an average of 6 months
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This scale measures momentary (state anxiety) and general (trait anxiety).
Scores range from 20-80.
Higher scores indicate greater anxiety
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Through study completion, an average of 6 months
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Connor-Davidson Resilience Scale
Ramy czasowe: Through study completion, an average of 6 months
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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.
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Through study completion, an average of 6 months
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Benefit Finding in Multiple Sclerosis Scale
Ramy czasowe: Through study completion, an average of 6 months
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This scale measures finding meaning and positive adjustment to MS. Scores range from 43-139.
Higher scores indicate greater benefit finding.
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Through study completion, an average of 6 months
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Cope Inventory
Ramy czasowe: Through study completion, an average of 6 months
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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.
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Through study completion, an average of 6 months
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- R-1164-21
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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Badania kliniczne na Reinvention with MS
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Hasselt UniversityZakończony
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