Treatment for Migraine and Mood (Team-M)
TEAM-M
2 other identifiers
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2021
CompletedFirst Posted
Study publicly available on registry
August 5, 2021
CompletedStudy Start
First participant enrolled
November 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2022
CompletedResults Posted
Study results publicly available
July 18, 2023
CompletedJuly 18, 2023
June 1, 2023
7 months
August 1, 2021
June 1, 2023
June 26, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Treatment Session Adherence Rate
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.
Week 8
Average Client Satisfaction Questionnaire Score (CSQ-8)
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."
Week 8
Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS)
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.
Week 8
Homework Assignment Completion Rate
Defined as the proportion of assigned home-based practice that participants completed each week.
Week 8
Study Arms (2)
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)
EXPERIMENTALMindfulness-based cognitive therapy delivered by Telephone
MBCT-V (Mindfulness-Based Cognitive Therapy - Video)
EXPERIMENTALMindfulness-based cognitive therapy delivered by Video
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amanda Shallcross
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda Shallcross, ND, MPH
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2021
First Posted
August 5, 2021
Study Start
November 11, 2021
Primary Completion
June 13, 2022
Study Completion
June 13, 2022
Last Updated
July 18, 2023
Results First Posted
July 18, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.