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Search / Trial NCT04613362

TelemEdiciNe-bAsed Cognitive TherapY for Migraines

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Oct 27, 2020

Trial Information

Current as of April 28, 2025

Completed

Keywords

Implementation Science Telehealth Cognitive Behavioral Therapy

ClinConnect Summary

With VHA's infrastructure dedicated to efficient telehealth delivery into patient homes, the delivery of a behavioral intervention for chronic migraine, CM, via the telehealth platform is primed to address barriers of in-person care delivery and holds considerable promise to reach and improve Veteran headache-related quality of life. Therefore, the goal is to evaluate an adapted bundle of EB implementation strategies to increase adoption of a Telemedicine-based Cognitive Behavioral Therapy (CBT) program (TENACITY) for CM in 2 VA HCoEs (VA Connecticut Healthcare System \[VACHS\], a large, mu...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Veteran patients eligible to participate must have:
  • A chronic migraine headache ICD-10 diagnosis;
  • Completion of at least 28 headache diary days;
  • A confirmed frequency of at least 8 headache days per month;
  • A primary complaint of headache
  • Exclusion Criteria:
  • Veteran patients not eligible to participate include:
  • Non-Veterans;
  • Veteran patients without a CM headache ICD-10 diagnosis;
  • Veteran patients whose primary pain complaint is not headache;
  • Veteran patients who have received greater than or equal to 90 days of opioid therapy for chronic low back pain from the date of chart screening;
  • Veteran patients who do not speak English;
  • Veteran patients who have a current diagnosis of severe cognitive impairment indicated by clinical provider, medical chart, or Short Portable Mental Status Questionnaire (SPMSQ);
  • Veteran patients who have Post Traumatic headache;
  • Veteran patients who have a diagnosis of cluster headache, other primary headache, post-whiplash headache, secondary headache, or trigeminal autonomic cephalalgia.
  • Any patients currently suffering from a disabling psychiatric illness (as noted by clinician);
  • Veteran patients who self-report Traumatic Brain Injury less than or equal to 1 year before diagnosis of Chronic Migraine, or worsening of Chronic Migraine.
  • Veteran patients who relate daily suicidal ideation within the last 2 weeks as indicated by the PHQ-9 with an answer of "3" to question nine;
  • Veteran patients who have severe depression, as indicated by PHQ-9 score greater than or equal to 20;
  • Veteran patients who are deemed by clinicians who are unable to participate in this trial;
  • Patients who are terminally ill (life expectancy of \<12 months as noted by clinician);
  • Patients who are homeless or live in long-term care, nursing home, rehabilitation, or domiciliary services, etc.
  • Veteran patients who decline to or cannot use the Annie App;
  • Veteran patients who decline to or cannot use My HealtheVet secure messaging
  • Veteran patients who have been treated by a HCoE clinical health psychologist in the last two years

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Dallas, Texas, United States

Birmingham, Alabama, United States

Indianapolis, Indiana, United States

West Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Teresa M. Damush, PhD

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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