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Treatment for Migraine and Mood RCT (TEAM-M)

Primary Purpose

Migraine, Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone
Video
Online
Sponsored by
Albert Einstein College of Medicine
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 (International Classification for Headache Disorders - 3rd Edition) criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
  • Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
  • Score between 5-14 on the PHQ-9 (Patient Health Questionnaire)
  • Age ≥ 18
  • Ability to read and speak English
  • Capacity to consent
  • Prospective diary-confirmed 4-14 headache days per month, with at least one attack meeting migraine criteria
  • ≥1 year of migraine

Exclusion Criteria:

  • Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module
  • Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake
  • Changes in longer-term migraine prevention (onabotulinum toxin A, injectable or oral anti-calcitonin gene related peptide treatment; neuromodulatory device) within 3 months of intake
  • Changes in acute migraine treatment started within 4 weeks of enrollment
  • Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the 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; bipolar disorder; obsessive-compulsive disorder, drug use
  • Prior history of engaging in formal mindfulness-based interventions including: MBSR (Mindfulness-based stress reduction), MBCT (Mindfulness-based cognitive therapy), Acceptance and Commitment therapy, Dialectical Behavior Therapy
  • Current daily meditation practice
  • Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days)
  • Unwilling to maintain stable current acute or preventive medication dosages for study duration
  • Any condition that would prevent being a suitable candidate or interfere with medical care needs
  • Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days).

Sites / Locations

  • Albert Einstein College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Telephone

Video

Online

Arm Description

8 weekly classes delivered via telephone.

8 weekly classes delivered via video.

8 weekly online modules delivered via web portal.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 10, 2022
Last Updated
September 6, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
Yeshiva University, Wake Forest University Health Sciences, The Cleveland Clinic, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05576467
Brief Title
Treatment for Migraine and Mood RCT
Acronym
TEAM-M
Official Title
Treatment for Migraine and Mood
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
Yeshiva University, Wake Forest University Health Sciences, The Cleveland Clinic, 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 three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (Telephone), video (Video) or online education modules (Online).
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 pilot is aimed evaluating the feasibility and acceptability of the Telephone and Video MBCT and Online education modules 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, Depressive Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telephone
Arm Type
Active Comparator
Arm Description
8 weekly classes delivered via telephone.
Arm Title
Video
Arm Type
Active Comparator
Arm Description
8 weekly classes delivered via video.
Arm Title
Online
Arm Type
Active Comparator
Arm Description
8 weekly online modules delivered via web portal.
Intervention Type
Behavioral
Intervention Name(s)
Telephone
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Treatment Session Adherence
Description
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.
Time Frame
Week 8
Title
Client Satisfaction Questionnaire - 8 (CSQ-8)
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change in Headache Disability Inventory (HDI)
Description
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.
Time Frame
Month 0 to Month 3
Title
Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)
Description
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.
Time Frame
Month 0 to Month 3
Title
Change in Quick Inventory of Depressive Symptomatology - Self-Report 16 (QIDS-SR16)
Description
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.
Time Frame
Month 0 to Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently meets ICHD-3 (International Classification for Headache Disorders - 3rd Edition) criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria Score between 5-14 on the PHQ-9 (Patient Health Questionnaire) Age ≥ 18 Ability to read and speak English Capacity to consent Prospective diary-confirmed 4-14 headache days per month, with at least one attack meeting migraine criteria ≥1 year of migraine Exclusion Criteria: Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake Changes in longer-term migraine prevention (onabotulinum toxin A, injectable or oral anti-calcitonin gene related peptide treatment; neuromodulatory device) within 3 months of intake Changes in acute migraine treatment started within 4 weeks of enrollment Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the 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; bipolar disorder; obsessive-compulsive disorder, drug use Prior history of engaging in formal mindfulness-based interventions including: MBSR (Mindfulness-based stress reduction), MBCT (Mindfulness-based cognitive therapy), Acceptance and Commitment therapy, Dialectical Behavior Therapy Current daily meditation practice Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days) Unwilling to maintain stable current acute or preventive medication dosages for study duration Any condition that would prevent being a suitable candidate or interfere with medical care needs Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Ladenheim, Ph.D.
Phone
914 468-4575
Email
barbara.ladenheim@einsteinmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth K Seng, Ph.D.
Organizational Affiliation
Albert Einstein College of Medicine and Yeshiva University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda J Shallcross, M.P.H., N.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth seng.elizabeth@gmail.com, PhD
Phone
646-592-4368
First Name & Middle Initial & Last Name & Degree
Barbara Ladenheim, PhD
Phone
914-468-4575
Email
barbara.ladenheim@einsteinmed.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Individual participant data will become available at the conclusion of the study upon request by qualified individuals in the research community.

Learn more about this trial

Treatment for Migraine and Mood RCT

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