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.
Brief Title
Treatment for Migraine and Mood (Team-M)
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
Depression
Eligibility Criteria
Inclusion Criteria:
* Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache
* Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5-14 on the PHQ-9
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent
Exclusion Criteria:
* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the Structure Diagnostic Interview for Headache
* 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
* 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
* Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current meditation practice \>3x/week
* Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache
* Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5-14 on the PHQ-9
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent
Exclusion Criteria:
* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the Structure Diagnostic Interview for Headache
* 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
* 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
* Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current meditation practice \>3x/week
Inclusion Criteria
Inclusion Criteria:
* Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache
* Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5-14 on the PHQ-9
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent
* Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache
* Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5-14 on the PHQ-9
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04992494
Org Class
Other
Org Full Name
NYU Langone Health
Org Study Id
20-01911
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Treatment for Migraine and Mood (Team-M): A Pilot Trial of a Mindfulness-based Training Program
Primary Outcomes
Outcome Description
Treatment Session Adherence is a measure of treatment feasibility and is defined as the number of scheduled treatments that were attended by the participants. This measure will be assessed through electronic monitoring of the attendance logs of each treatment session. A treatment arm will be considered feasible if participants attended/read 75% of sessions on average.
Outcome Measure
Treatment Session Adherence Rate
Outcome Time Frame
Week 8
Outcome Description
The CSQ-8 is an 8-item generic standardized self-report tool to measure satisfaction with health and human services received by individuals and families. An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 version, scores range from 8 to 32, with higher values indicating higher satisfaction. A threshold score of greater than or equal to 24 is the cut-off for "Acceptability."
Outcome Measure
Average Client Satisfaction Questionnaire Score (CSQ-8)
Outcome Time Frame
Week 8
Outcome Description
The mindfulness-based cognitive therapy (MBCT)-TACS is an assessment of treatment fidelity in terms of adherence and competence. 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 higher the fidelity.
Outcome Measure
Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS)
Outcome Time Frame
Week 8
Outcome Description
Defined as the proportion of assigned home-based practice that participants completed each week.
Outcome Measure
Homework Assignment Completion Rate
Outcome Time Frame
Week 8
Secondary Ids
Secondary Id
R01AT011005
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Elizabeth Seng
Investigator Email
elizabeth.seng@einsteinmed.org
Investigator Phone