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Completed

NCT Number: NCT03982316

Telehealth Behavioral Migraine Management

This project aims to develop the protocol and obtain feasibility and acceptability information for Telehealth Behavioral Migraine Management in a single-arm pre-post pilot study. The investigator and study team aim to recruit 20 people with migraine from the Montefiore Headache Center in the Bronx New York. Participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physician diagnosis of migraine
  • Current self-reported symptoms meeting the International Classification for Headache Disorders -- 3 criteria for migraine
  • Self-reported between 4 and 20 headache days/month
  • Aged 18-65
  • Can read English
  • Capacity to consent

Exclusion criteria

  • Psychiatric illness that would interfere with study participation
  • Meeting criteria for probable medication overuse headache

Treatment and study plan

Telehealth Behavioral Migraine Management

Behavioral
  • Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.

Education Modules

Behavioral

Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete.

Primary outcomes

  1. Feasibility of TeleBMM

    Time frame: Week 0 through Week 12

    Feasibility of the study will be based on patient adherence to the protocol. The number of treatment components participants complete (out of 20) will be tabulated. It is hypothesized that at least half of the participants will attend all four study sessions and complete all three self-guided modules. Dropouts will be included in the analysis. Results will be summarized using basic descriptive statistics.

  2. Acceptability - Patient-Rated Satisfaction

    Time frame: Post-treatment survey at Week 12

    Patient-rated satisfaction (acceptability) with the program will be based on responses to the overall satisfaction question on a satisfaction survey. Participants are asked to rate overall satisfaction with the Telehealth Behavioral Management Program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied"). Acceptability was to have been evaluated both on completers and assuming that individuals who dropped out were not satisfied (i.e., "Not at all satisfied").

Secondary outcomes

  1. Change in Quality of Life (Migraine Specific)

    Time frame: Change from Pre-treatment (Week 0) to Post-treatment (Week 12)

    Change in Migraine-related disability over the prior 4 week period was assessed based on Version 2.1 of the Migraine Specific Quality of Life Questionnaire (MSQ). The MSQ is a 14-item survey assessing quality of life in people with migraine. Responses from the 14 Items (which are reverse-coded) encompassing three domains (Role Restriction - 7 items; Role Prevention - 4 items; and Emotional Function - 3 items) were rated on a 6-point scale ranging from 1 ("None of the time") to 6 ("All of the time"). Raw scores were summed and linearly converted to a 0-100 scale wherein higher scores are associated with a better quality of life. For purposes of this study, change from baseline was assessed such that higher scores reflect an increased quality of life from baseline and negative scores reflect a decreased quality of life from baseline. Scores are summarized by study arm using descriptive statistics.

  2. Change in Headache Frequency

    Time frame: Change from Week 0 to Week 12

    Participants were asked to complete a daily headache diary, on which each 7 day week they denoted whether they have had a headache attack. Slope change from Week 0 to Week 12 is reported as a proportion of headache days/month (ranging from 0-1) and is summarized by study arm.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Acronym: TeleBMM

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2019
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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