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Bronx MBCT-Migraine (BMBCT-M)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443519
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Elizabeth Seng, Albert Einstein College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine
Intervention Behavioral: MBCT for Migraine
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Period Title: Overall Study
Started 31 29
Completed 29 26
Not Completed 2 3
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual Total
Hide Arm/Group Description

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint. Total of all reporting groups
Overall Number of Baseline Participants 31 29 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 29 participants 60 participants
36.2  (10.6) 44.2  (11.5) 40.1  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
Female
29
  93.5%
26
  89.7%
55
  91.7%
Male
2
   6.5%
3
  10.3%
5
   8.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
Hispanic or Latino
5
  16.1%
5
  17.2%
10
  16.7%
Not Hispanic or Latino
26
  83.9%
24
  82.8%
50
  83.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   6.5%
1
   3.4%
3
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   3.4%
1
   1.7%
White
26
  83.9%
23
  79.3%
49
  81.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   9.7%
4
  13.8%
7
  11.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 29 participants 60 participants
31 29 60
Headache Disability Inventory (HDI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants 29 participants 60 participants
52.5  (21.2) 50.2  (16.2) 51.4  (19.0)
[1]
Measure Description: The HDI is a scale that ranges from 0-100, with higher scores indicating higher levels of headache disability.
Migraine Disability Assessment (MIDAS) Score >=21   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
MIDAS Severe (Score >=21)
24
  77.4%
26
  89.7%
50
  83.3%
MIDAS Not Severe (Score < 21)
7
  22.6%
3
  10.3%
10
  16.7%
[1]
Measure Description: The MIDAS is a scale 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).
Headache Day Frequency (>=15 days/30 days)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
>= 15 days/month
16
  51.6%
15
  51.7%
31
  51.7%
< 15 days/month
15
  48.4%
14
  48.3%
29
  48.3%
1.Primary Outcome
Title Proportion of People With "Severe" Scores on the Migraine Disability Assessment
Hide Description 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."
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 77.4 89.7
Month 4 58.1 75.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .027
Comments Significance threshold set a priori at .025 to adjust for two co-primary outcomes.
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-0.7 to 3.9
Estimation Comments A positive slope indicates greater reduction in the proportino of people with Severe MIDAS scores (Score >=21) in the MBCT-M group vs. the WL/TAU group.
2.Primary Outcome
Title Headache-Related Disability Index
Hide Description 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.
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 52.5  (21.2) 50.2  (16.2)
Month 4 38.2  (16.6) 50.4  (14.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.004
Comments Significance threshold set a priori at .025 to account for two co-primary outcomes.
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value 14.1
Confidence Interval (2-Sided) 95%
0.8 to 21.8
Estimation Comments Positive slope indicated larger reductions in HDI in the MBCT-M group compared to the WL/TAU group.
3.Secondary Outcome
Title Headache Days (Over Course of 1 Month)
Hide Description Number of headache days/month for the month prior to treatment, and the month after treatment
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: Days/30 days
Month 1 16.5  (6.0) 15.5  (5.9)
Month 4 14.8  (4.8) 14.2  (4.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .773
Comments Threshold for statistical significance set a priori at .05.
Method Mixed Models Analysis
Comments Key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with Treatment and Time in the model
Method of Estimation Estimation Parameter Slope
Estimated Value -.05
Confidence Interval (2-Sided) 95%
-3.7 to 2.8
Estimation Comments A positive slope indicates greater reduction in headache days in the MBCT-M group vs. the WL/TAU group.
4.Secondary Outcome
Title Average Headache Severity for Headache Days Recorded Over 30 Days
Hide Description 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.
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 1.7  (0.3) 1.8  (0.3)
Month 4 1.6  (0.3) 1.7  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .888
Comments Threshold for significance set a priori at .05.
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.14 to 0.16
Estimation Comments A positive slope indicates a greater reduction in headache attack pain intensity in the MBCT-M group vs. WL/TAU.
5.Secondary Outcome
Title The Pain Catastrophizing Scale
Hide Description 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.
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 22.6  (8.7) 22.0  (7.8)
Month 4 15.6  (8.8) 22.6  (10.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .035
Comments [Not Specified]
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value 7.45
Confidence Interval (2-Sided) 95%
2.48 to 12.42
Estimation Comments A positive slope indicates a greater reduction in Pain Catastrophizing Scale in the MBCT-M group vs. WL/TAU.
6.Secondary Outcome
Title Chronic Pain Acceptance Questionnaire
Hide Description 20-item, self-report measure of pain-related acceptance. Total scores range from 0-156 with higher scores indicating higher pain acceptance.
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 60.7  (20.2) 60.3  (14.0)
Month 4 68.0  (9.2) 64.7  (7.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .572
Comments [Not Specified]
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value -3.05
Confidence Interval (2-Sided) 95%
-10.83 to 4.74
Estimation Comments A negative slope indicates a greater improvement in Chronic Pain Acceptance in the MBCT-M group vs. WL/TAU.
7.Secondary Outcome
Title Five Facet Mindfulness Questionnaire
Hide Description 39-item self-report instrument assessing mindfulness. Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 128.5  (17.6) 132.9  (18.3)
Month 4 116.0  (8.6) 117.7  (10.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .609
Comments Threshold for significance set a priori at .05.
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value -2.65
Confidence Interval (2-Sided) 95%
-11.76 to 6.46
Estimation Comments A negative slope indicates a smaller decrease in the Five Factor Mindfulness Questionnaire in the MBCT-M group vs. WL/TAU.
8.Secondary Outcome
Title Headache Specific Locus of Control
Hide Description 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.
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 86.0  (10.5) 87.5  (14.3)
Month 4 80.3  (11.8) 89.8  (17.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .022
Comments Threshold for significance set a priori at .05.
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value 8.45
Confidence Interval (2-Sided) 95%
2.99 to 13.91
Estimation Comments A positive slope indicates a greater reduction in Headache Specific Locus of Control Scale score in the MBCT-M group vs. WL/TAU.
9.Secondary Outcome
Title Headache Management Self-efficacy Scale
Hide Description 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
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 108.1  (11.9) 111.8  (13.5)
Month 4 113.8  (12.6) 115.4  (11.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .124
Comments Threshold for significance set a priori at .05.
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value -2.01
Confidence Interval (2-Sided) 95%
-7.56 to 3.53
Estimation Comments A negative slope indicates a greater improvement in Headache Management Self-Efficacy Scale score in the MBCT-M group vs. WL/TAU.
10.Secondary Outcome
Title NIH PROMIS Depression Short Form
Hide Description 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.
Time Frame Change from Month 1 to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 54.0  (60.2) 53.1  (7.4)
Month 4 52.2  (6.8) 55.9  (6.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .017
Comments Threshold for significance set a priori at .05.
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value 3.48
Confidence Interval (2-Sided) 95%
0.63 to 6.33
Estimation Comments A positive slope indicates a greater reduction in PROMIS-Depression score in the MBCT-M group vs. WL/TAU.
11.Secondary Outcome
Title NIH PROMIS Anxiety Short Form
Hide Description 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.
Time Frame Change from Month 1 to Month 4
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 56.7  (8.2) 56.2  (6.2)
Month 4 55.7  (8.1) 59.2  (7.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .259
Comments Threshold for significance set a priori at .05.
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value 2.82
Confidence Interval (2-Sided) 95%
-0.03 to 5.68
Estimation Comments A positive slope indicates a greater reduction in PROMIS-Anxiety score in the MBCT-M group vs. WL/TAU.
12.Secondary Outcome
Title Average Monthly Migraine Disability Index
Hide Description 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.
Time Frame Change from Month 1 through Month 4
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description:

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 2.8  (1.6) 3.4  (2.0)
Month 4 1.7  (2.7) 4.4  (1.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBCT for Migraine, Wait List/Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .007
Comments [Not Specified]
Method Mixed Models Analysis
Comments The key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with both Treatment and Time in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.6 to -0.3
Estimation Comments A negative slope indicated a larger decrease in MIDI scores in the MBCT-M group vs. WL/TAU
Time Frame 4 months
Adverse Event Reporting Description Adverse events were tracked on a monthly basis by research staff in both groups. Participants in the MBCT-M group were also tracked weekly by the study therapist during the two-month treatment period (Month 2 and Month 3).
 
Arm/Group Title MBCT for Migraine Wait List/Treatment as Usual
Hide Arm/Group Description

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.

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

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
All-Cause Mortality
MBCT for Migraine Wait List/Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)      0/29 (0.00%)    
Hide Serious Adverse Events
MBCT for Migraine Wait List/Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/29 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MBCT for Migraine Wait List/Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/31 (6.45%)      0/29 (0.00%)    
Nervous system disorders     
Increase in headache frequency and intensity * [1]  1/31 (3.23%)  1 0/29 (0.00%)  0
Psychiatric disorders     
Flooding * [2]  1/31 (3.23%)  1 0/29 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Sudden and severe increase in headache frequency and intensity
[2]
A vivid recollection of a traumatic event
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Dr. Elizabeth Seng
Organization: Yeshiva University & Albert Einstein College of Medicine
Phone: 646-592-4368
EMail: elizabeth.seng@yu.edu
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Responsible Party: Elizabeth Seng, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02443519    
Other Study ID Numbers: 2015-4684
First Submitted: May 8, 2015
First Posted: May 14, 2015
Results First Submitted: November 6, 2019
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020