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Single Arm Trial Identifying Barriers and Facilitators to Mindfulness Practice

22 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Erin G Mistretta, PhD
  • Telefonnummer: 206-668-4168
  • E-post: emistr@uw.edu

Studera Kontakt Backup

  • Namn: Dawn Ehde, PhD
  • Telefonnummer: 206-744-2811
  • E-post: edhe@uw.edu

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • Rekrytering
        • University of Washington
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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 3 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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 6-12 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.
Beteende: MBCT
Participants will attend eight, 2-hour group treatment MBCT sessions delivered using free video-conferencing technology. Groups will consist of 6-12 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Daily Mindfulness Practice
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Type of Mindfulness Practice
Tidsram: 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
Tidsram: 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)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain Intensity
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Washington

Samarbetspartners

National Center for Complementary and Integrative Health (NCCIH)

Utredare

  • Huvudutredare: Erin Mistretta, PhD, University of Washington

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 juli 2026

Primärt slutförande (Beräknad)

31 mars 2028

Avslutad studie (Beräknad)

30 juni 2028

Studieregistreringsdatum

Först inskickad

1 maj 2026

Först inskickad som uppfyllde QC-kriterierna

1 maj 2026

Första postat (Faktisk)

7 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00023785
  • 1K23AT013270-01A1 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

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Nej

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