- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02443519
Bronx MBCT-Migraine (BMBCT-M)
17. september 2020 opdateret af: Elizabeth Seng, Albert Einstein College of Medicine
Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial
This randomized clinical trial aims to examine the effect of a standardized 8-week course of Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people with migraine.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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Bronx, New York, Forenede Stater, 10461
- Yeshiva University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- ICHD-3 beta headache diagnosis of migraine,
- self-reported and diary-confirmed 4-20 headache days per month
- aged 18-65
- ability to read English
- capacity to consent.
Exclusion Criteria:
- no ICHD-3 beta headache diagnosis of migraine
- fewer than 4 or greater than 20 headache days per month
- under 18 or over 65
- inability to read English
- lacking the capacity to consent
- utilization of new preventative pain treatments within four weeks of the baseline assessment, or a plan to utilize new preventive pain medications during the duration of the study
- severe psychiatric illness that would interfere with participation in the treatment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: MBCT for Migraine
In this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day & Thorn).
Participants will attend weekly 75-90 minute individual sessions for eight weeks.
At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain).
Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc).
Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.
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8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
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Ingen indgriben: Wait List/Treatment as Usual
Patients will continue with standard care.
Patients will be offered MBCT after the primary endpoint.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of People With "Severe" Scores on the Migraine Disability Assessment
Tidsramme: Change from Month 1 to Month 4
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The MIDAS is a 5-item, self-report instrument that assesses the number of days in the past three months participants experienced partially or fully reduced functioning in a variety of contexts (work, school, social).
MIDAS scores are totaled and interpreted in the following grades: 0-5 = Grade I (Little or no disability); 6-10 = Grade II (Mild disability); 11-20 = Grade III (Moderate disability); 21+ = Grade IV (Severe disability).
Scores were dichotomized at "Not Severe" (Grades I, II, and III) and "Severe "(Grade IV).
The outcome was the proportion of participants who reported "Severe Disability."
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Change from Month 1 to Month 4
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Headache-Related Disability Index
Tidsramme: Change from Month 1 to Month 4
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25-item, self-report questionnaire of the emotional and functional impact of headache on daily activities.
Total scores range from 0-100, with higher scores indicating higher levels of disability.
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Change from Month 1 to Month 4
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Headache Days (Over Course of 1 Month)
Tidsramme: Change from Month 1 to Month 4
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Number of headache days/month for the month prior to treatment, and the month after treatment
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Change from Month 1 to Month 4
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Average Headache Severity for Headache Days Recorded Over 30 Days
Tidsramme: Change from Month 1 to Month 4
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Headache Severity was recorded for every headache day on a scale of 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Average headache severity was averaged across all headache days for each month.
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Change from Month 1 to Month 4
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The Pain Catastrophizing Scale
Tidsramme: Change from Month 1 to Month 4
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13-item self-report measure that conveys a participant's level of pain-related, catastrophic thinking during painful experiences.
Total scores range from 0-52, with higher scores indicating higher levels of catastrophizing.
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Change from Month 1 to Month 4
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Chronic Pain Acceptance Questionnaire
Tidsramme: Change from Month 1 to Month 4
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20-item, self-report measure of pain-related acceptance.
Total scores range from 0-156 with higher scores indicating higher pain acceptance.
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Change from Month 1 to Month 4
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Five Facet Mindfulness Questionnaire
Tidsramme: Change from Month 1 to Month 4
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39-item self-report instrument assessing mindfulness.
Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.
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Change from Month 1 to Month 4
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Headache Specific Locus of Control
Tidsramme: Change from Month 1 to Month 4
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33-item measure designed to assess the extent to which individuals with recurrent headaches expect that the occurrence, worsening, and improvement of their headaches are influenced primarily by their own behavior, by chance or fate, or by the actions of medical professionals.
Total scores range from 33-165, with higher scores indicating more external (vs.
internal) locus of control.
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Change from Month 1 to Month 4
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Headache Management Self-efficacy Scale
Tidsramme: Change from Month 1 to Month 4
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25-item self-report scale designed to capture the confidence a patient believes they have in their own abilities to prevent headache episodes and manage their pain.
Total scores range from 25-175, with higher scores indicating higher levels of self-efficacy
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Change from Month 1 to Month 4
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NIH PROMIS Depression Short Form
Tidsramme: Change from Month 1 to Month 4
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8-item self-report measure that assesses emotional distress in the past week focusing on negative mood and negative self-views.
Scores are normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of depressive symptoms.
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Change from Month 1 to Month 4
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NIH PROMIS Anxiety Short Form
Tidsramme: Change from Month 1 to Month 4
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8-item self-report measure that assesses emotional distress in the past week focusing on fear, worry and hyper-arousal.
Scores were normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of anxious symptoms.
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Change from Month 1 to Month 4
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Average Monthly Migraine Disability Index
Tidsramme: Change from Month 1 through Month 4
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A daily 4-item measure of migraine related disability.
Scores range from 0-10, with higher scores indicating higher levels of disability.
Scores are averaged across all headache days recorded each month.
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Change from Month 1 through Month 4
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2015
Primær færdiggørelse (Faktiske)
1. oktober 2018
Studieafslutning (Faktiske)
1. februar 2019
Datoer for studieregistrering
Først indsendt
8. maj 2015
Først indsendt, der opfyldte QC-kriterier
11. maj 2015
Først opslået (Skøn)
14. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015-4684
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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