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Treatment for Migraine and Mood (Team-M) (TEAM-M)

Primary Purpose

Migraine, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MBCT-Telephone
MBCT-Video
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)

MBCT-V (Mindfulness-Based Cognitive Therapy - Video)

Arm Description

Mindfulness-based cognitive therapy delivered by Telephone

Mindfulness-based cognitive therapy delivered by Video

Outcomes

Primary Outcome Measures

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.
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."
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.
Homework Assignment Completion Rate
Defined as the proportion of assigned home-based practice that participants completed each week.

Secondary Outcome Measures

Full Information

First Posted
August 1, 2021
Last Updated
June 26, 2023
Sponsor
NYU Langone Health
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04992494
Brief Title
Treatment for Migraine and Mood (Team-M)
Acronym
TEAM-M
Official Title
Treatment for Migraine and Mood (Team-M): A Pilot Trial of a Mindfulness-based Training Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)
Arm Type
Experimental
Arm Description
Mindfulness-based cognitive therapy delivered by Telephone
Arm Title
MBCT-V (Mindfulness-Based Cognitive Therapy - Video)
Arm Type
Experimental
Arm Description
Mindfulness-based cognitive therapy delivered by Video
Intervention Type
Behavioral
Intervention Name(s)
MBCT-Telephone
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MBCT-Video
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Session Adherence Rate
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.
Time Frame
Week 8
Title
Average Client Satisfaction Questionnaire Score (CSQ-8)
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."
Time Frame
Week 8
Title
Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS)
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.
Time Frame
Week 8
Title
Homework Assignment Completion Rate
Description
Defined as the proportion of assigned home-based practice that participants completed each week.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Shallcross, ND, MPH
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

Treatment for Migraine and Mood (Team-M)

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