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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT011005 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Yeshiva University | OTHER |
| Wake Forest University Health Sciences | OTHER |
| The Cleveland Clinic | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) |
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The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).
This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This pilot is aimed at evaluating the feasibility and acceptability of the Telephone and Video MBCT and EUC in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBCT-Telephone | Active Comparator | 8 weekly classes delivered via telephone. |
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| MBCT-Video | Active Comparator | 8 weekly classes delivered via video. |
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| Enhanced Usual Care (EUC) | Active Comparator | 8 weekly online modules delivered via web portal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBCT-Telephone | Behavioral | Classes follow MBCT protocol delivered via telephone by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treatment Session Adherence | Treatment Session Adherence is a measure of treatment feasibility. This measure will be assessed through electronic monitoring of the attendance logs of each treatment session. The number of treatment sessions attended will be recorded. A treatment arm will be considered feasible if participants attended/read 75% of sessions on average. | Week 8 |
| Client Satisfaction Questionnaire - 8 (CSQ-8) | The CSQ-8 assesses treatment acceptability. The CSQ-8 is an 8-item self-report measure designed to assess satisfaction with mental health services. Response options are coded on a 4-point scale and summed to produce a total score ranging from 8-32. The measure has consistently demonstrated excellent reliability and validity, and is commonly used in behavioral treatment trials. For the purposes of this study, a CSQ-8 score > 24 is considered acceptable. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Headache Disability Inventory (HDI) | The HDI is a 25-item self-report survey which assesses perceived emotional and functional impact of headache on daily activities. Sample items include, "Because of my headaches I feel restricted in performing my routine daily activities," with response options of "Yes," "Sometimes," and "No." Total scores range from 0-100, with higher scores indicating higher disability. The slope of change between Month 0 and 3 represents a secondary outcome designed to evaluate clinical signal in this pilot study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth K Seng, Ph.D. | Albert Einstein College of Medicine and Yeshiva University | Principal Investigator |
| Amanda J Shallcross, M.P.H., N.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States | ||
| Wake Forest University School of Medicine |
Individual participant data will be available upon request to qualified individuals in the research community. If this research develops or improves any technologies or techniques, this work will be made available to qualified individuals in the research community.
Individual participant data will become available at the conclusion of the study upon request by qualified individuals in the research community.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| NIH |
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| MBCT-Video | Behavioral | Classes follow MBCT protocol delivered via video by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium. |
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| Enhanced Usual Care (EUC) | Behavioral | Weekly online modules follow migraine and behavior principles delivered via web portal developed by a team of licensed clinical psychologists, neurologists, and mental health providers. |
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| Month 0 to Month 3 |
| Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ) | The MSQ is a 14-item self-report survey which assesses quality of life over the past 4 weeks in people with migraine. Items comprise three subscales: Role Restriction, Role Prevention, and Emotion Function. Each item is scored on a Likert-type scale from 1 ("None of the time") to 6 ("All of the time"). Total scores range from 14-84. The slope of change between Month 0 and 3 represents a secondary outcome designed to evaluate clinical signal in this pilot study. | Month 0 to Month 3 |
| Change in Quick Inventory of Depressive Symptomatology - Self-Report 16 (QIDS-SR16) | The QIDS-SR16 measures depressive symptom domains during the prior 7 days. Each item is scored on a scale from 0 to 3 points. Total scores range from 0 to 27. Score cutoffs are: 1-5 for no depression, 6-10 for mild depression, 11-15 for moderate depression, 16-20 for severe depression, and 17-27 for very severe depression. The slope of change between Month 0 and 3 represents a secondary outcome designed to evaluate clinical signal in this pilot study. | Month 0 to Month 3 |
| Winston-Salem |
| North Carolina |
| 27101 |
| United States |
| The Cleveland Clinic | Cleveland | Ohio | 44106 | United States |
| D009422 | Nervous System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |