TelemEdiciNe-bAsed Cognitive TherapY for Migraines (TENACITY)

  • STATUS
    Recruiting
  • End date
    Jun 20, 2023
  • participants needed
    150
  • sponsor
    VA Office of Research and Development
Updated on 25 March 2022
headache
chronic migraine

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.

Description

With VHA's infrastructure dedicated to efficient telehealth delivery into patient homes, the delivery of a behavioral intervention for chronic migrane, 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, multi-disciplinary HCoE, and Birmingham VA Medical Center [BVAMC], a smaller VA Headache Consortium Center. The HCoEs are charged with improving headache care throughout the VA, not just within an individual VAMC. As part of this study, a non-HCoE will also participate, providing an opportunity for the TENACITY study to extend this virtual specialty headache care to Veterans without headache specialty care. Dallas VA Medical Center, also known as the North Texas Health Care System [NTHCS] will participate as a third site.

The investigators will determine whether TENACITY can be efficiently delivered through the vehicle of telehealth by conducting a pilot randomly controlled trial (RCT) comparing a) TENACITY to b). usual care plus education.

The investigators will recruit Veterans diagnosed with chronic migraine headaches until the investigators have reached approximately 150 eligible Veterans participants across the 3 VAMCs. The investigators will randomize eligible Veterans to participate either in the TENACITY intervention (n=75) or treatment as usual(n=75).

The specific aims are threefold:

Aim 1: To develop a bundle of evidence-based practice (EBP) implementation strategies to engage 3 VA Medical Centers [2 Headache Centers of Excellence HCoEs and 1 general neurology service] and facilitate their local adaptation and implementation of Cognitive Behavioral Therapy (CBT) (TENACITY) through the vehicle of telehealth services.

Hypothesis 1a. HCoE clinical providers will report high acceptability, appropriateness and fidelity of TENACITY at 3 months and maintenance at 6 months.

Hypothesis 1b. TENACITY reach, adoption, and implementation will vary by HCoE local context as evaluated by the Consolidated Framework for Implementation Research (CFIR) inner settings.

Aim 2. To conduct a pilot RCT and determine the preliminary efficacy and feasibility of TENACITY compared to usual care in outpatient, in person facilities across 3 VA HCoE sites.

Hypothesis 2: Veterans receiving TENACITY will experience a statistically significant reduction in routine clinical headache metrics: headache frequency [headache days per month] (primary outcome), headache-related impairment and psychological symptoms (secondary outcomes) compared to usual care at 3 and 6 months.

Aim 3: The investigators will conduct exploratory cost analysis of TENACITY from the Veteran's perspective, using inputs from the pilot RCT, and a two-year budget impact analysis from the VHA's perspective, incorporating the costs of implementation as well as direct costs (and cost-savings,) of providing the TENACITY intervention over all HCoEs to VHA.

Hypothesis 3: TENACITY will be cost-effective and provide value to Veterans and VHA.

Details
Condition Migraine Headache
Treatment TENACITY Telehealth Cognitive Behavioral Therapy for Migraines, Usual Care Outpatient Cognitive Behavioral Therapy for Migraines Face to Face
Clinical Study IdentifierNCT04613362
SponsorVA Office of Research and Development
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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 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
Veterans patients whose primary pain complaint is not headache
Veteran patients who have received 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 1 year before diagnosis of Chronic Migraine, or worsening of Chronic Migraine
Veteran patients who have had suicidal ideation within the last 2 weeks and as indicated by the PHQ-9
Veteran patients who have severe depression, as indicated by PHQ-9 score greater than 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 clinical health psychologist in the last two years utilizing CBT
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