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TelemEdiciNe-bAsed Cognitive TherapY for Migraines

NCT04613362 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Migraine Headache

Interventions

BEHAVIORAL

TENACITY Telehealth Cognitive Behavioral Therapy for Migraine

Clinical health psychology therapy delivered via telehealth

BEHAVIORAL

Behavioral Usual Care

Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Teresa M. Damush, PhD · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2023-04-29
Completion
2023-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04613362 on ClinicalTrials.gov