MigraineTEAM-MNCT05576467
Treatment for Migraine and Mood
A study testing MBCT-Telephone and MBCT-Video in people with Migraine and Depressive Symptoms, run by Amanda Shallcross at 3 sites in United States.
Trial summary
The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Depressive Symptoms
- What is being tested?
- MBCT-Telephone and MBCT-Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Mar 2024to 26 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently meets ICHD-3 criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
- Self-reported 4-20 headache days per month
- Score between 5-19 on the PHQ-8
- Age ≥ 18
- Ability to read and speak English
- Capacity to consent
- ≥1 year of migraine
Who cannot join
- 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 anti-depressant medication within 6 weeks of intake
- Starting or changing a migraine preventive treatment (i.e., oral medication, injection, preventive medicine, neuromodulatory device) within 12 weeks 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 MBCT-T intervention, including but not limited to: active suicidal ideation; current or recent history (in the last six months) of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities;, discomfort participating in a group-based intervention, drug use
- Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
Show all 10Show fewer
- Current daily meditation practice
- Unwilling to maintain stable current acute or preventive medication dosages for study duration
- Any condition that would prevent being a suitable candidate for the group intervention
- Medication overuse headache with migraine treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Cleveland Clinic
Cleveland, Ohio, 44106
Albert Einstein College of Medicine
The Bronx, New York, 10461
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
About this study
Official title: Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program
The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).
Read the 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 at evaluating the feasibility and acceptability of the Telephone and Video MBCT and EUC 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).
- Conditions
- Migraine, Depressive Symptoms
- Being tested
- MBCT-Telephone, MBCT-Video, Enhanced Usual Care (EUC)
- Keywords
- mindfulness, mindfulness-based cognitive therapy
- Medical subject headings
- Migraine Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT-TelephoneBehavioural
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.
MBCT-VideoBehavioural
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.
Enhanced Usual Care (EUC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBCT-Telephone | Active comparator | 8 weekly classes delivered via telephone. Receives: Behavioral: MBCT-Telephone |
| MBCT-Video | Active comparator | 8 weekly classes delivered via video. Receives: Behavioral: MBCT-Video |
| Enhanced Usual Care (EUC) | Active comparator | 8 weekly online modules delivered via web portal. Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
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.
Measured: Week 8
Secondary outcomes (3)
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.
Measured: Month 0 to Month 3
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.
Measured: Month 0 to Month 3
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.
Measured: Month 0 to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start17 Mar 2024
- Primary completion24 Mar 2026
- Study completion26 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amanda Shallcross
- Sponsor type
- University, hospital or other
- Collaborators
- Yeshiva University, Wake Forest University Health Sciences, The Cleveland Clinic, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Amanda Shallcross, The Cleveland Clinic
- Investigators
- Elizabeth K Seng, Ph.D., Principal investigator, Albert Einstein College of Medicine and Yeshiva UniversityAmanda J Shallcross, M.P.H., N.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576467
- Sponsor's protocol ID
- 20225608
- Other IDs
- R01AT011005
- Acronym
- TEAM-M
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Siwik CJ, Tankha H, Hill JD, Visvanathan P, Gaskins D, DeSciscio M, McCarty N, O'Brien H, Salvaterra M, Wang C, Lipton R, Wells RE, Seng E, Shallcross AJ. Evaluating an Abbreviated Version of Mindfulness-Based Cognitive Therapy Delivered via Telephone or Videoconferencing Compared to Enhanced Usual Care-Treatment for Migraine and Mood (TEAM-M) Study: Protocol for a Three-Arm Multisite Randomized Controlled Feasibility Trial. JMIR Res Protoc. 2026 Jun 5;15:e93627. doi: 10.2196/93627.
PubMed 42247631
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program
- ClinicalTrials.gov ID
- NCT05576467
- Acronym / sponsor ID
- TEAM-M / 20225608
- Conditions
- Migraine, Depressive Symptoms
- Keywords
- mindfulness, mindfulness-based cognitive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Amanda ShallcrossUniversity, hospital or other
- Collaborators
- Yeshiva University, Wake Forest University Health Sciences, The Cleveland Clinic, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 17 Mar 2024 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 26 Oct 2026 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).
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 at evaluating the feasibility and acceptability of the Telephone and Video MBCT and EUC 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBCT-Telephone | Active comparator | Behavioral: MBCT-Telephone8 weekly classes delivered via telephone. |
| MBCT-Video | Active comparator | Behavioral: MBCT-Video8 weekly classes delivered via video. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual Care (EUC)8 weekly online modules delivered via web portal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Currently meets ICHD-3 criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
- Self-reported 4-20 headache days per month
- Score between 5-19 on the PHQ-8
- Age ≥ 18
- Ability to read and speak English
Key exclusion criteria (10 listed)
- 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 anti-depressant medication within 6 weeks of intake
- Starting or changing a migraine preventive treatment (i.e., oral medication, injection, preventive medicine, neuromodulatory device) within 12 weeks 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 MBCT-T intervention, including but not limited to: active suicidal ideation; current or recent history (in the last six months) of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities;, discomfort participating in a group-based intervention, drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBCT-TelephoneClasses 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. | Behavioural | MBCT-Telephone |
| MBCT-VideoClasses 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. | Behavioural | MBCT-Video |
| Enhanced Usual Care (EUC)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. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
Percentage of Treatment Session Adherence
Time frame: 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 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)
Time frame: Week 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.
3 secondary outcomes
Change in Headache Disability Inventory (HDI)
Time frame: Month 0 to Month 3
Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)
Time frame: Month 0 to Month 3
Change in Quick Inventory of Depressive Symptomatology - Self-Report 16 (QIDS-SR16)
Time frame: Month 0 to Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 42247631Siwik CJ, Tankha H, Hill JD, Visvanathan P, Gaskins D, DeSciscio M, McCarty N, O'Brien H, Salvaterra M, Wang C, Lipton R, Wells RE, Seng E, Shallcross AJ. Evaluating an Abbreviated Version of Mindfulness-Based Cognitive Therapy Delivered via Telephone or Videoconferencing Compared to Enhanced Usual Care-Treatment for Migraine and Mood (TEAM-M) Study: Protocol for a Three-Arm Multisite Randomized Controlled Feasibility Trial. JMIR Res Protoc. 2026 Jun 5;15:e93627. doi: 10.2196/93627.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K Seng, Ph.D. principal investigator
Albert Einstein College of Medicine and Yeshiva University
Amanda J Shallcross, M.P.H., N.D. principal investigator
The Cleveland Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT-Telephone and MBCT-Video in people with Migraine and Depressive Symptoms, run by Amanda Shallcross at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Treatment Session Adherence (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.