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- Klinische proef NCT02443519
Bronx MBCT-Migraine (BMBCT-M)
17 september 2020 bijgewerkt door: 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.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New York
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Bronx, New York, Verenigde Staten, 10461
- Yeshiva University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Geen tussenkomst: Wait List/Treatment as Usual
Patients will continue with standard care.
Patients will be offered MBCT after the primary endpoint.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Proportion of People With "Severe" Scores on the Migraine Disability Assessment
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Headache Days (Over Course of 1 Month)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2015
Primaire voltooiing (Werkelijk)
1 oktober 2018
Studie voltooiing (Werkelijk)
1 februari 2019
Studieregistratiedata
Eerst ingediend
8 mei 2015
Eerst ingediend dat voldeed aan de QC-criteria
11 mei 2015
Eerst geplaatst (Schatting)
14 mei 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 oktober 2020
Laatste update ingediend die voldeed aan QC-criteria
17 september 2020
Laatst geverifieerd
1 september 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2015-4684
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