Trial Outcomes & Findings for Bronx MBCT-Migraine (NCT NCT02443519)
NCT ID: NCT02443519
Last Updated: 2020-10-12
Results Overview
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."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Change from Month 1 to Month 4
Results posted on
2020-10-12
Participant Flow
Participant milestones
| Measure |
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.
MBCT for Migraine: 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
|
Wait List/Treatment as Usual
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
29
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bronx MBCT-Migraine
Baseline characteristics by cohort
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Headache Disability Inventory (HDI)
|
52.5 units on a scale
STANDARD_DEVIATION 21.2 • n=5 Participants
|
50.2 units on a scale
STANDARD_DEVIATION 16.2 • n=7 Participants
|
51.4 units on a scale
STANDARD_DEVIATION 19.0 • n=5 Participants
|
|
Migraine Disability Assessment (MIDAS) Score >=21
MIDAS Severe (Score >=21)
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Migraine Disability Assessment (MIDAS) Score >=21
MIDAS Not Severe (Score < 21)
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Headache Day Frequency (>=15 days/30 days)
>= 15 days/month
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Headache Day Frequency (>=15 days/30 days)
< 15 days/month
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Month 1 to Month 4The 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."
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Proportion of People With "Severe" Scores on the Migraine Disability Assessment
Month 1
|
77.4 percentage of participants
|
89.7 percentage of participants
|
|
Proportion of People With "Severe" Scores on the Migraine Disability Assessment
Month 4
|
58.1 percentage of participants
|
75.9 percentage of participants
|
PRIMARY outcome
Timeframe: Change from Month 1 to Month 425-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.
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Headache-Related Disability Index
Month 1
|
52.5 score on a scale
Standard Deviation 21.2
|
50.2 score on a scale
Standard Deviation 16.2
|
|
Headache-Related Disability Index
Month 4
|
38.2 score on a scale
Standard Deviation 16.6
|
50.4 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 4Number of headache days/month for the month prior to treatment, and the month after treatment
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Headache Days (Over Course of 1 Month)
Month 1
|
16.5 Days/30 days
Standard Deviation 6.0
|
15.5 Days/30 days
Standard Deviation 5.9
|
|
Headache Days (Over Course of 1 Month)
Month 4
|
14.8 Days/30 days
Standard Deviation 4.8
|
14.2 Days/30 days
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 4Headache 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.
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Average Headache Severity for Headache Days Recorded Over 30 Days
Month 1
|
1.7 units on a scale
Standard Deviation 0.3
|
1.8 units on a scale
Standard Deviation 0.3
|
|
Average Headache Severity for Headache Days Recorded Over 30 Days
Month 4
|
1.6 units on a scale
Standard Deviation 0.3
|
1.7 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 413-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.
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
The Pain Catastrophizing Scale
Month 1
|
22.6 score on a scale
Standard Deviation 8.7
|
22.0 score on a scale
Standard Deviation 7.8
|
|
The Pain Catastrophizing Scale
Month 4
|
15.6 score on a scale
Standard Deviation 8.8
|
22.6 score on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 420-item, self-report measure of pain-related acceptance. Total scores range from 0-156 with higher scores indicating higher pain acceptance.
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Chronic Pain Acceptance Questionnaire
Month 1
|
60.7 score on a scale
Standard Deviation 20.2
|
60.3 score on a scale
Standard Deviation 14.0
|
|
Chronic Pain Acceptance Questionnaire
Month 4
|
68.0 score on a scale
Standard Deviation 9.2
|
64.7 score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 439-item self-report instrument assessing mindfulness. Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire
Month 1
|
128.5 score on a scale
Standard Deviation 17.6
|
132.9 score on a scale
Standard Deviation 18.3
|
|
Five Facet Mindfulness Questionnaire
Month 4
|
116.0 score on a scale
Standard Deviation 8.6
|
117.7 score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 433-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.
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Headache Specific Locus of Control
Month 1
|
86.0 score on a scale
Standard Deviation 10.5
|
87.5 score on a scale
Standard Deviation 14.3
|
|
Headache Specific Locus of Control
Month 4
|
80.3 score on a scale
Standard Deviation 11.8
|
89.8 score on a scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 425-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
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Headache Management Self-efficacy Scale
Month 1
|
108.1 score on a scale
Standard Deviation 11.9
|
111.8 score on a scale
Standard Deviation 13.5
|
|
Headache Management Self-efficacy Scale
Month 4
|
113.8 score on a scale
Standard Deviation 12.6
|
115.4 score on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 48-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.
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
NIH PROMIS Depression Short Form
Month 1
|
54.0 score on a scale
Standard Deviation 60.2
|
53.1 score on a scale
Standard Deviation 7.4
|
|
NIH PROMIS Depression Short Form
Month 4
|
52.2 score on a scale
Standard Deviation 6.8
|
55.9 score on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 48-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.
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
NIH PROMIS Anxiety Short Form
Month 1
|
56.7 score on a scale
Standard Deviation 8.2
|
56.2 score on a scale
Standard Deviation 6.2
|
|
NIH PROMIS Anxiety Short Form
Month 4
|
55.7 score on a scale
Standard Deviation 8.1
|
59.2 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Change from Month 1 through Month 4A 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.
Outcome measures
| Measure |
MBCT for Migraine
n=31 Participants
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
|
Wait List/Treatment as Usual
n=29 Participants
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Average Monthly Migraine Disability Index
Month 1
|
2.8 score on a scale
Standard Deviation 1.6
|
3.4 score on a scale
Standard Deviation 2.0
|
|
Average Monthly Migraine Disability Index
Month 4
|
1.7 score on a scale
Standard Deviation 2.7
|
4.4 score on a scale
Standard Deviation 1.3
|
Adverse Events
MBCT for Migraine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Wait List/Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MBCT for Migraine
n=31 participants at risk
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
|
Wait List/Treatment as Usual
n=29 participants at risk
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
|
|---|---|---|
|
Psychiatric disorders
Flooding
|
3.2%
1/31 • Number of events 1 • 4 months
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).
|
0.00%
0/29 • 4 months
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).
|
|
Nervous system disorders
Increase in headache frequency and intensity
|
3.2%
1/31 • Number of events 1 • 4 months
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).
|
0.00%
0/29 • 4 months
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).
|
Additional Information
Dr. Elizabeth Seng
Yeshiva University & Albert Einstein College of Medicine
Phone: 646-592-4368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place