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Single Arm Trial Identifying Barriers and Facilitators to Mindfulness Practice

1 maja 2026 zaktualizowane przez: Erin Mistretta, University of Washington
This observational study will examine what emotional, physical, and environmental factors make it easier or harder for people with multiple sclerosis (MS) and chronic pain to practice mindfulness daily while participating in a group-based Mindfulness-Based Cognitive Therapy (MBCT) program.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Chronic pain affects about half of people with multiple sclerosis (PwMS), and standard drug treatments often provide limited relief. Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week program that combines mindfulness practices with cognitive and behavioral coping skills and has shown positive effects on pain severity, pain interference, and pain catastrophizing in PwMS. However, daily home practice is essential to achieving these benefits, and adherence is poor. People with chronic pain complete less than 40 out of every 100 recommended practice sessions. PwMS face unique barriers to practice including pain, fatigue, cognitive difficulties, and mood changes that can fluctuate within a single day. Understanding what drives or interferes with daily practice in this population is critical to improving MBCT outcomes.

This single-arm trial is the first aim of a research project designed to develop and optimize a smartphone-based just-in-time adaptive intervention (JITAI) to support mindfulness practice in PwMS during MBCT for chronic pain (1K23AT013270-01A1, Mistretta, PI). In this aim, 80 PwMS will participate in an 8-week group-based MBCT program delivered via telehealth. Ecological momentary assessment (EMA), a method of collecting real-time self-report data via smartphone, will be used to capture emotional, physical, and environmental factors as they naturally occur in daily life. Participants will complete twice-daily EMA surveys using an EMA smartphone app for 1 week before the program, during the 8-week program, and for 1 week after the program ends. Patient-reported outcome measures will be collected before and after the program.

The primary outcome is whether a participant practiced mindfulness between each EMA survey. Secondary outcomes include minutes practiced, type of practice (formal or informal), and self-rated quality of practice. Time-varying predictors assessed via EMA include positive and negative affect, stress, pain severity, pain interference, fatigue, sleep, location, social context, and time of day. Time-invariant predictors assessed at baseline include pain severity, pain interference, fatigue, pain catastrophizing, dispositional mindfulness, sleep, self-efficacy, depression, and cognitive functioning.

Multilevel modeling will be used to account for the nested data structure (assessments within days, within participants). A two-part modeling approach will assess both whether practice occurred on a given day and, on days when practice did occur, how much practice was completed. Three sets of models will examine same-day, longitudinal, and lagged relationships between predictors and practice outcomes. Predictors demonstrating at least a medium within-person effect on mindfulness practice will be considered as tailoring variables for the JITAI developed in the next phase of this project.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Erin G Mistretta, PhD
  • Numer telefonu: 206-668-4168
  • E-mail: emistr@uw.edu

Kopia zapasowa kontaktu do badania

  • Nazwa: Dawn Ehde, PhD
  • Numer telefonu: 206-744-2811
  • E-mail: edhe@uw.edu

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Have an MS diagnosis of any subtype per record review
  • Average pain intensity in past week of at least moderate severity (>3 on the 0-10 numerical rating scale)
  • Report pain >50% of days in the past 6 months.
  • Are able to comply with study procedures and complete measures independently via self-report (on mobile phone)

Exclusion Criteria:

  • Less than 18 years of age
  • Score greater than 8 on the Expanded Disability Status Scale
  • Have significant cognitive impairment as indicated by 1 or more errors on the 6-item Cognitive Screener
  • Change in disease modifying medications in the past 3 months assessed via self-report (although participants will be considered eligible after the 3-month window)
  • History of MS relapse within the last 30 days prior to screening assessed via self-report (although participants will be considered eligible after the 3-month window)
  • Current suicidal ideation with intent or plan as indicated by a score of 1 or higher on the Patient Health Questionnaire-9 suicide item and further assessment with the Columbia-Suicide Severity Rating Scale (although individuals with suicidal ideation but no intent or plan will be considered eligible)
  • Currently engaged in psychotherapy for pain assessed via self-report
  • Currently have a "regular" mindfulness practice defined as > 3 days per week assessed via self-report
  • Inability to read or speak English

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Mindfulness-Based Cognitive Therapy (MBCT)
Participants will attend eight, 2-hour group treatment MBCT sessions delivered using free video-conferencing technology. Groups will consist of 8-10 people who also have MS and chronic pain. Participants will be asked to practice skills learned in session between sessions. MBCT integrates mindfulness meditation practices within a CBT-oriented framework to address not only unhelpful pain cognitions and behaviors but also attentional control, decoupling of attention from emotion, mindful cognitions, and meditative behavior.
Behawioralne: MBCT
Participants will attend eight, 2-hour group treatment MBCT sessions delivered using free video-conferencing technology. Groups will consist of 8-10 people who also have MS and chronic pain. Participants will be asked to practice skills learned in session between sessions. MBCT integrates mindfulness meditation practices within a CBT-oriented framework to address not only unhelpful pain cognitions and behaviors but also attentional control, decoupling of attention from emotion, mindful cognitions, and meditative behavior.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Daily Mindfulness Practice
Ramy czasowe: Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)
Whether a participant engaged in any formal (for example, sitting meditation) or informal (for example, mindfully engaging in a daily task) mindfulness practice since the last check-in, assessed via a single yes or now question delivered twice daily through the smartphone app. This will also be tracked passively by indicating whether participants accessed a guided meditation in the app itself.
Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Type of Mindfulness Practice
Ramy czasowe: Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)
Whether the mindfulness practice completed since the last check-in was formal (for example, sitting meditation using a guided audio recording) or informal (for example, mindfully engaging in a daily task), assessed via a single multiple choice question delivered twice daily through the smartphone app.
Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)
Quality of Mindfulness Practice
Ramy czasowe: Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)
A participant's self-rated quality of their most recent mindfulness practice since the last check-in, assessed via the 1-item Practice Quality-Mindfulness (PQM) scale delivered twice daily through the smartphone app. A higher score indicates higher self-report practice quality.
Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Pain Intensity
Ramy czasowe: Pre-intervention and post-intervention (approximately 10 weeks apart)
Participant-rated pain severity assessed via the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity scale at pre- and post-intervention.
Pre-intervention and post-intervention (approximately 10 weeks apart)
Pain Interference
Ramy czasowe: Pre-intervention and post-intervention (approximately 10 weeks apart)
The degree to which pain limits a participant's daily activities and functioning, assessed via the 6-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale at pre- and post-intervention.
Pre-intervention and post-intervention (approximately 10 weeks apart)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Washington

Współpracownicy

National Center for Complementary and Integrative Health (NCCIH)

Śledczy

  • Główny śledczy: Erin Mistretta, PhD, University of Washington

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2027

Ukończenie studiów (Szacowany)

30 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

1 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 maja 2026

Pierwszy wysłany (Rzeczywisty)

7 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY00023785
  • 1K23AT013270-01A1 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Upon publication, researchers may request a de-identified dataset containing all variables used in the published article. Requestors will receive the published article, a variable list with labels, and the dataset as an SPSS (.sav) file. Although data files will be stripped of identifiers prior to sharing, there remains a small risk that individuals with unusual combinations of characteristics could potentially be re-identified through deduction. To minimize this risk, the investigators will review each dataset prior to sharing and remove or collapse any variables that could increase re-identification risk.

Ramy czasowe udostępniania IPD

The data used for the analyses for any papers published will become available to interested researchers by request after that article is published. Those data will continue to be available for at least five years following the publication of the article.

Kryteria dostępu do udostępniania IPD

The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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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