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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02443519
Other study ID # 2015-4684
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date February 2019

Study information

Verified date September 2020
Source Albert Einstein College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2019
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MBCT for Migraine
8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework

Locations

Country Name City State
United States Yeshiva University Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of People With "Severe" Scores on the Migraine Disability Assessment 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." Change from Month 1 to Month 4
Primary Headache-Related Disability Index 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. Change from Month 1 to Month 4
Secondary Headache Days (Over Course of 1 Month) Number of headache days/month for the month prior to treatment, and the month after treatment Change from Month 1 to Month 4
Secondary Average Headache Severity for Headache Days Recorded Over 30 Days 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. Change from Month 1 to Month 4
Secondary The Pain Catastrophizing Scale 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. Change from Month 1 to Month 4
Secondary Chronic Pain Acceptance Questionnaire 20-item, self-report measure of pain-related acceptance. Total scores range from 0-156 with higher scores indicating higher pain acceptance. Change from Month 1 to Month 4
Secondary Five Facet Mindfulness Questionnaire 39-item self-report instrument assessing mindfulness. Total scores range from 39-195, with higher scores indicating higher levels of mindfulness. Change from Month 1 to Month 4
Secondary Headache Specific Locus of Control 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. Change from Month 1 to Month 4
Secondary Headache Management Self-efficacy Scale 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 Change from Month 1 to Month 4
Secondary NIH PROMIS Depression Short Form 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. Change from Month 1 to Month 4
Secondary NIH PROMIS Anxiety Short Form 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. Change from Month 1 to Month 4
Secondary Average Monthly Migraine Disability Index 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. Change from Month 1 through Month 4
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