TelemEdiciNe-bAsed Cognitive TherapY for Migraines

Completed · Not applicable

Conditions studied: Migraine Headache

In brief

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.

Key facts

Study ID

NCT04613362

Run by

VA Office of Research and Development

People needed

80

Starts

2021-04-22

Expected to finish

2023-05-31

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States
• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States
• Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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