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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002556 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This project aims to develop the protocol and obtain feasibility and acceptability information for Telehealth Behavioral Migraine Management in a single-arm pre-post pilot study. The investigator and study team aim to recruit 20 people with migraine from the Montefiore Headache Center in the Bronx New York. Participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth Behavioral Migraine Management | Experimental | 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. |
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| Education Modules | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Behavioral Migraine Management | Behavioral | 1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of TeleBMM | 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. | Week 0 through Week 12 |
| Acceptability - Patient-Rated Satisfaction | 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"). | Post-treatment survey at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life (Migraine Specific) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth K Seng, Ph.D. | Yeshiva University/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of TeleBMM | 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 measure only applies to participants in the TeleBMM study arm. | Posted | Mean | Standard Deviation | Treatment Components Completed | Week 0 through Week 12 |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The study did not achieve targeted sample per arm and therefore results are not generalizable and should be considered hypothesis-generating.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Seng | Albert Einstein College of Medicine | 646-592-4368 | Elizabeth.Seng@yu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2023 | Dec 16, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2024 | Dec 16, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Education Modules | Behavioral | Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete. |
|
| Change from Pre-treatment (Week 0) to Post-treatment (Week 12) |
| Change in Headache Frequency | 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. | Change from Week 0 to Week 12 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Quality of Life (Migraine Specific) | Migraine-related disability over the prior 4 week period was assessed at baseline using V2.1 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 reverse-coded Items encompassing 3 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 converted to a 0-100 scale. Higher scores are associated with a better quality of life. | Mean | Standard Deviation | score on a scale |
|
| Monthly Proportion of Headache Days | At baseline, following consent and group assignment, participants were queried regarding recent headache frequency using a survey. Based on responses, the monthly proportion of headache days was quantified. Results have been summarized by study arm. | Mean | Standard Deviation | Proportion of headache days/month |
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|
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| Primary | Acceptability - Patient-Rated Satisfaction | 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"). | 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. | Posted | Post-treatment survey at Week 12 |
|
|
| Secondary | Change in Quality of Life (Migraine Specific) | 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. | One participant did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | Change from Pre-treatment (Week 0) to Post-treatment (Week 12) |
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|
|
|
| Secondary | Change in Headache Frequency | 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. | Results summarized in proportion of headache days/month to account for "missingness" of calendar days over the three month period. | Posted | Mean | Standard Deviation | proportion of headache days/month | Change from Week 0 to Week 12 |
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|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D009422 | Nervous System Diseases |
| Slope |
| 18.58 |
| 2-Sided |
| 95 |
| -1.85 |
| 39.02 |
| Other |
Change from Week 0 to Week 12 |
| Odds Ratio (OR) |
| 1.026 |
| 2-Sided |
| 95 |
| 1.001 |
| 1.050 |
| Other |
Within-group change over time |