Trial Outcomes & Findings for Telehealth Behavioral Migraine Management (NCT NCT03982316)
NCT ID: NCT03982316
Last Updated: 2026-03-11
Results Overview
Feasibility of the study will be based on patient adherence to the protocol. The number of treatment components participants complete (out of 20) will be tabulated. It is hypothesized that at least half of the participants will attend all four study sessions and complete all three self-guided modules. Dropouts will be included in the analysis. Results will be summarized using basic descriptive statistics.
COMPLETED
NA
20 participants
Week 0 through Week 12
2026-03-11
Participant Flow
Participants were permitted to select which arm they wished to enroll in during this study, as this was a pilot for feasibility. No participants chose the third arm.
Participant milestones
| Measure |
Telehealth Behavioral Migraine Management
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
Telehealth Behavioral Migraine Management: 1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
|
Education Modules
Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention
|
Cognitive Behavioral Therapy for Headache Disorders (CBT-HD)
Participants who choose CBT-HD treatment will receive six 50-minute telephone sessions, once every two weeks. These sessions will be provided by a doctoral psychology student in a clinical health psychology program covering these topics.
Participants will complete a daily headache diary throughout the course of treatment. Participants will also complete brief questionnaires after each session.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
0
|
|
Overall Study
COMPLETED
|
7
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
0
|
Reasons for withdrawal
| Measure |
Telehealth Behavioral Migraine Management
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
Telehealth Behavioral Migraine Management: 1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
|
Education Modules
Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention
|
Cognitive Behavioral Therapy for Headache Disorders (CBT-HD)
Participants who choose CBT-HD treatment will receive six 50-minute telephone sessions, once every two weeks. These sessions will be provided by a doctoral psychology student in a clinical health psychology program covering these topics.
Participants will complete a daily headache diary throughout the course of treatment. Participants will also complete brief questionnaires after each session.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
0
|
Baseline Characteristics
Telehealth Behavioral Migraine Management
Baseline characteristics by cohort
| Measure |
Telehealth Behavioral Migraine Management
n=14 Participants
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
Telehealth Behavioral Migraine Management: 1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
|
Education Modules
n=6 Participants
Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
20 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 9.8 • n=9 Participants
|
40.4 years
STANDARD_DEVIATION 3.7 • n=9 Participants
|
40.6 years
STANDARD_DEVIATION 8.6 • n=18 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
20 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
5 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
13 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=9 Participants
|
6 participants
n=9 Participants
|
20 participants
n=18 Participants
|
|
Quality of Life (Migraine Specific)
|
43.6 score on a scale
STANDARD_DEVIATION 19.0 • n=9 Participants
|
58.6 score on a scale
STANDARD_DEVIATION 22.6 • n=9 Participants
|
47.8 score on a scale
STANDARD_DEVIATION 21.2 • n=18 Participants
|
|
Monthly Proportion of Headache Days
|
0.52 Proportion of headache days/month
STANDARD_DEVIATION 0.002 • n=9 Participants
|
0.44 Proportion of headache days/month
STANDARD_DEVIATION 0.01 • n=9 Participants
|
0.50 Proportion of headache days/month
STANDARD_DEVIATION 0.04 • n=18 Participants
|
PRIMARY outcome
Timeframe: Week 0 through Week 12Population: Outcome measure only applies to participants in the TeleBMM study arm.
Feasibility of the study will be based on patient adherence to the protocol. The number of treatment components participants complete (out of 20) will be tabulated. It is hypothesized that at least half of the participants will attend all four study sessions and complete all three self-guided modules. Dropouts will be included in the analysis. Results will be summarized using basic descriptive statistics.
Outcome measures
| Measure |
Telehealth Behavioral Migraine Management
n=14 Participants
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
Telehealth Behavioral Migraine Management: 1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
|
Education Modules
Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, \\Biofeedback, and Relapse Prevention. Participants will complete a daily headache diary throughout the course of treatment.
Education Modules: Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete.
|
|---|---|---|
|
Feasibility of TeleBMM
|
14.2 Treatment Components Completed
Standard Deviation 5.6
|
—
|
PRIMARY outcome
Timeframe: Post-treatment survey at Week 12Population: Satisfaction surveys were not administered as they were omitted from the post-test forms. Consequently, no participants completed the patient satisfaction survey item and there are no results to report for this outcome.
Patient-rated satisfaction (acceptability) with the program will be based on responses to the overall satisfaction question on a satisfaction survey. Participants are asked to rate overall satisfaction with the Telehealth Behavioral Management Program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied"). Acceptability was to have been evaluated both on completers and assuming that individuals who dropped out were not satisfied (i.e., "Not at all satisfied").
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Pre-treatment (Week 0) to Post-treatment (Week 12)Population: One participant did not complete this measure.
Change in Migraine-related disability over the prior 4 week period was assessed based on Version 2.1 of the Migraine Specific Quality of Life Questionnaire (MSQ). The MSQ is a 14-item survey assessing quality of life in people with migraine. Responses from the 14 Items (which are reverse-coded) encompassing three domains (Role Restriction - 7 items; Role Prevention - 4 items; and Emotional Function - 3 items) were rated on a 6-point scale ranging from 1 ("None of the time") to 6 ("All of the time"). Raw scores were summed and linearly converted to a 0-100 scale wherein higher scores are associated with a better quality of life. For purposes of this study, change from baseline was assessed such that higher scores reflect an increased quality of life from baseline and negative scores reflect a decreased quality of life from baseline. Scores are summarized by study arm using descriptive statistics.
Outcome measures
| Measure |
Telehealth Behavioral Migraine Management
n=6 Participants
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
Telehealth Behavioral Migraine Management: 1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
|
Education Modules
n=2 Participants
Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, \\Biofeedback, and Relapse Prevention. Participants will complete a daily headache diary throughout the course of treatment.
Education Modules: Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete.
|
|---|---|---|
|
Change in Quality of Life (Migraine Specific)
|
9.3 score on a scale
Standard Deviation 27.6
|
-11.4 score on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Change from Week 0 to Week 12Population: Results summarized in proportion of headache days/month to account for "missingness" of calendar days over the three month period.
Participants were asked to complete a daily headache diary, on which each 7 day week they denoted whether they have had a headache attack. Slope change from Week 0 to Week 12 is reported as a proportion of headache days/month (ranging from 0-1) and is summarized by study arm.
Outcome measures
| Measure |
Telehealth Behavioral Migraine Management
n=11 Participants
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
Telehealth Behavioral Migraine Management: 1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
|
Education Modules
n=5 Participants
Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, \\Biofeedback, and Relapse Prevention. Participants will complete a daily headache diary throughout the course of treatment.
Education Modules: Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete.
|
|---|---|---|
|
Change in Headache Frequency
|
.13 proportion of headache days/month
Standard Deviation .004
|
.18 proportion of headache days/month
Standard Deviation .017
|
Adverse Events
Telehealth Behavioral Migraine Management
Education Modules
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place