Trial results for a study investigating Telehealth Behavioral Migraine Management (TeleBMM) for Migraine were posted on ClinicalTrials.gov on 2026-03-11. This pilot study enrolled 20 participants to assess the feasibility and acceptability of the intervention.
Background
Migraine is a debilitating neurological condition characterized by severe headaches, often accompanied by symptoms such as throbbing pain, nausea, vomiting, and sensitivity to light and sound. It significantly impacts quality of life and productivity. While pharmacological treatments are available, behavioral therapies, including cognitive behavioral therapy (CBT), have shown efficacy in migraine management by helping patients cope with pain, reduce headache frequency, and improve overall well-being. The integration of telehealth technologies can make these behavioral interventions more accessible, particularly for individuals who face barriers to in-person care.
Trial design
This completed study, designated as Phase NA, was a single-arm pre-post pilot study that enrolled 20 participants with Migraine from the Montefiore Headache Center. The project aimed to develop a protocol and obtain feasibility and acceptability information for Telehealth Behavioral Migraine Management. Participants received a 12-week protocol that included a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.
Key results
The trial reported several key measurements:
- Feasibility of TeleBMM (Treatment Components Completed):
- For Telehealth Behavioral Migraine Management, the mean was 14.2 (Standard Deviation 5.6).
- Change in Quality of Life (Migraine Specific) (score on a scale):
- For Telehealth Behavioral Migraine Management, the mean change was 9.3 (Standard Deviation 27.6).
- For Education Modules, the mean change was -11.4 (Standard Deviation 14.4).
- Change in Headache Frequency (proportion of headache days/month):
- For Telehealth Behavioral Migraine Management, the mean change was 0.13 (Standard Deviation 0.004).
- For Education Control, the mean change was 0.18 (Standard Deviation 0.017).
Additional analyses reported:
- A Slope of -2.32 (95.0% Confidence Interval: -27.07 to 22.44).
- A Slope of 18.58 (95.0% Confidence Interval: -1.85 to 39.02).
- An Odds Ratio (OR) of 1.009 (95.0% Confidence Interval: 1.001 to 1.017).
- An Odds Ratio (OR) of 1.026 (95.0% Confidence Interval: 1.001 to 1.05).
What this means
The posted results from this pilot study provide initial data on the feasibility and preliminary outcomes of a Telehealth Behavioral Migraine Management program. The reported mean of 14.2 treatment components completed suggests a reasonable level of engagement with the intervention. The observed mean change of 9.3 in migraine-specific quality of life for the Telehealth Behavioral Migraine Management group indicates a potential positive impact, while a mean reduction of 0.13 in the proportion of headache days/month also suggests a favorable direction. These findings support the potential utility of telehealth-based behavioral interventions for migraine, warranting further investigation in larger, controlled studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03982316, titled "Telehealth Behavioral Migraine Management", were posted on 2026-03-11 on clinicaltrials.gov.