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NCT04613362 · ClinicalTrials.gov registry record · NA
TelemEdiciNe-bAsed Cognitive TherapY for Migraines
A NA study of Migraine Headache, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 4
- Study locations
NCT04613362: Completed NA study of Migraine Headache, sponsored by VA Office of Research and Development.
NCT04613362 is a NA study of Migraine Headache that has completed, run by VA Office of Research and Development. The registered enrollment target is 80 participants, below the 146-participant average among 6 other Migraine Headache trials with a reported enrollment target (45% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04613362, a NA study of Migraine Headache, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 4
- Study locations
Study Summary
The goal of this pilot study is to evaluate a bundle of implementation strategies at three Veteran Affairs Medical Centers (VAMCs) to facilitate the referral and adoption of a telehealth based, cognitive behavioral therapy program delivered by Health Psychologists for Veterans with chronic migraine to inform a future fully-powered hybrid type 2 effectiveness-implementation design. Veteran patients will be randomized to either the telehealth delivered CBT or usual care. Headache symptoms and severity will be reported using a VA text messaging application.
Primary Outcome
Daily self-reported migraine headaches using a VA text message protocol
Conditions Studied
Interventions
- BEHAVIORAL TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
- BEHAVIORAL Behavioral Usual Care
Study Locations (4)
Alabama
- Birmingham VA Medical Center, Birmingham, AL - Birmingham
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven
Indiana
- Richard L. Roudebush VA Medical Center, Indianapolis, IN - Indianapolis
Texas
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2023-05-31 |
| Phase | NA |
What the finished NCT04613362 record still lists
NCT04613362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 146-participant average among 6 other Migraine Headache trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Migraine Headache appearing as the primary indexed condition, and to 2 interventions - of which TENACITY Telehealth Cognitive Behavioral Therapy for Migraine is the first listed.
NCT04613362 reports a single indexed study location in Alabama, Connecticut, Indiana.
Frequently Asked Questions
What is clinical trial NCT04613362 about?
NCT04613362 is a clinical study titled "TelemEdiciNe-bAsed Cognitive TherapY for Migraines". The goal of this pilot study is to evaluate a bundle of implementation strategies at three Veteran Affairs Medical Centers (VAMCs) to facilitate the referral and adoption of a telehealth based, cognitive behavioral therapy program delivered by Health Psychologists for Veterans with chronic migraine ...
What is the current status of trial NCT04613362?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2021-04-22. Estimated completion is 2023-05-31.
What conditions does trial NCT04613362 study?
This clinical trial studies the following conditions: Migraine Headache.
What interventions are being tested in trial NCT04613362?
The interventions under investigation include: TENACITY Telehealth Cognitive Behavioral Therapy for Migraine (BEHAVIORAL), Behavioral Usual Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT04613362?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04613362 being conducted?
This trial has 4 study locations across Alabama, Connecticut, Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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