Phase 2
N=16
Treatment for Migraine and Mood (Team-M)
Migraine · Depression
Bottom Line
View on ClinicalTrials.gov: NCT04992494 ↗Enrolled (actual)
16
Serious AEs
—
Results posted
Jul 2023
Primary outcome: Primary: Treatment Session Adherence Rate — 7.88; 8 Number of sessions attended
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MBCT-Telephone (Behavioral); MBCT-Video (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Session Adherence Rate |
7.88; 8 | — |
| PRIMARY Average Client Satisfaction Questionnaire Score (CSQ-8) |
29.3; 28.3 | — |
| PRIMARY Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS) |
2.9; 2.8 | — |
| PRIMARY Homework Assignment Completion Rate |
0.77; 0.57 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04992494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.