TEAM-M: Treatment for Migraine and Mood (Team-M)
Study Details
Study Description
Brief Summary
The researchers propose a two-arm pilot study of telephone and video delivered Mindfulness-based Cognitive Therapy (MBCT-T and MBCT-V) in people with migraine and depressive symptoms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This first phase is aimed at fidelity optimization of MBCT-T and MBCT-V 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) Mindfulness-based cognitive therapy delivered by Telephone |
Behavioral: MBCT-Telephone
Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via telephone by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.
|
| Experimental: MBCT-V (Mindfulness-Based Cognitive Therapy - Video) Mindfulness-based cognitive therapy delivered by Video |
Behavioral: MBCT-Video
Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via WebEx video-conferencing by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Treatment Session Adherence [Week 8]
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 MBCT-T/V treatment sessions attended will be recorded. A treatment arm will be considered feasible if participants attended/read 75% of sessions on average.
- Percentage of participants with greater than or equal to 95% of treatment components on Fidelity Checklist [Week 8]
The Fidelity Checklist has 30 treatment components. Each component is marked yes or no. If > 28 components are marked yes, it would be reported as greater than equal to 95%.
- Percentage of Scores on MBCT-T/V Adherence & Competence Scales (MBCT-TACS) that are on average greater than or equal to 2.5. [Week 8]
The scale has two components: formal components and teaching goals. The scores per session are recorded between 0-3 and averaged to get the total score. The total range of score is 0-3; the higher the score, the better.
- Percentage of Homework assignment adherence [Week 8]
Homework assignment adherence is another measure of treatment feasibility. During the intervention period, participants in the MBCT groups will be asked to record the amount of assigned home-based practice they completed each week.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache
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Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
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Score between 5-14 on the PHQ-9
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Age ≥ 18
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Ability to read and speak English
-
Capacity to consent
Exclusion Criteria:
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Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the Structure Diagnostic Interview for Headache
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Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake; changes in longer-term migraine prevention (onobotulinum toxin A, anti-calcitonin gene related peptide treatment) within 3 months of intake
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Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities
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Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
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Current meditation practice >3x/week
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Amanda Shallcross, ND, MPH, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-01911
- R01AT011005