MigrainePhase 2TEAM-MNCT04992494
Treatment for Migraine and Mood (Team-M)
A Phase 2 study testing MBCT-Telephone and MBCT-Video in people with Migraine and Depression, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Depression
- 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
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 13 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment for Migraine and Mood (Team-M): A Pilot Trial of a Mindfulness-based Training Program
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.
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 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).
- Conditions
- Migraine, Depression
- Being tested
- MBCT-Telephone, MBCT-Video
- 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
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.
MBCT-VideoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | Experimental | Mindfulness-based cognitive therapy delivered by Telephone Receives: Behavioral: MBCT-Telephone |
| MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Experimental | Mindfulness-based cognitive therapy delivered by Video Receives: Behavioral: MBCT-Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: 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.
Measured: Week 8
Homework Assignment Completion Rate
Defined as the proportion of assigned home-based practice that participants completed each week.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start11 Nov 2021
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Amanda Shallcross, ND, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992494
- Sponsor's protocol ID
- 20-01911
- Other IDs
- R01AT011005
- Acronym
- TEAM-M
- Status last verified
- Jun 2023
- First submitted
- 1 Aug 2021
- Last updated
- 18 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Seng EK, Hill J, Reeder AK, Visvanathan P, Wells RE, Lipton RB, Minen M, Shallcross AJ. Feasibility, acceptability, and fidelity of remote-delivered abbreviated mindfulness-based cognitive therapy interventions for patients with migraine and depressive symptoms. Headache. 2025 Apr;65(4):545-557. doi: 10.1111/head.14857. Epub 2024 Oct 14.
PubMed 39400343
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Migraine and Mood (Team-M): A Pilot Trial of a Mindfulness-based Training Program
- ClinicalTrials.gov ID
- NCT04992494
- Acronym / sponsor ID
- TEAM-M / 20-01911
- Conditions
- Migraine, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Posted 18 Jul 2023
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) | Experimental | Behavioral: MBCT-TelephoneMindfulness-based cognitive therapy delivered by Telephone |
| MBCT-V (Mindfulness-Based Cognitive Therapy - Video) | Experimental | Behavioral: MBCT-VideoMindfulness-based cognitive therapy delivered by Video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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-TelephoneMindfulness-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. | Behavioural | MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone) |
| MBCT-VideoMindfulness-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. | Behavioural | MBCT-V (Mindfulness-Based Cognitive Therapy - Video) |
Primary outcome
Treatment Session Adherence Rate
Time frame: Week 8
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)
Time frame: Week 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)
Time frame: Week 8
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
Time frame: Week 8
Defined as the proportion of assigned home-based practice that participants completed each week.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39400343Seng EK, Hill J, Reeder AK, Visvanathan P, Wells RE, Lipton RB, Minen M, Shallcross AJ. Feasibility, acceptability, and fidelity of remote-delivered abbreviated mindfulness-based cognitive therapy interventions for patients with migraine and depressive symptoms. Headache. 2025 Apr;65(4):545-557. doi: 10.1111/head.14857. Epub 2024 Oct 14.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Migraine, Migraine in Adolescence
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.
Amanda Shallcross, ND, MPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBCT-Telephone and MBCT-Video in people with Migraine and Depression, run by NYU Langone Health at 1 site 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 6 inclusion and 5 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 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Session Adherence Rate (time frame: Week 8). The study lists 4 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 NCT04992494, 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 18 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.