Trials / Active Not Recruiting
Active Not RecruitingNCT05576467
Treatment for Migraine and Mood
Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- Amanda Shallcross · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | MBCT-Telephone | 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. |
| BEHAVIORAL | MBCT-Video | 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. |
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2024-03-17
- Primary completion
- 2026-03-31
- Completion
- 2026-10-20
- First posted
- 2022-10-12
- Last updated
- 2026-02-11
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05576467. Inclusion in this directory is not an endorsement.