TENACITY: TelemEdiciNe-bAsed Cognitive Therapy for Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Number of Headache Days at 3 Months
研究概览
简要总结
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.
详细描述
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, 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) behavioral treatment as usual (TAU; i.e., behavioral usual care).
The investigators will recruit Veterans diagnosed with chronic migraine during the one-year recruitment period across the 3 VAMCs. The investigators will randomize eligible Veterans to participate either in the TENACITY intervention (n=50) or treatment as usual (n=50).
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant will be randomized by mode of delivery to the telehealth or TAU treatment stratified by site (VA Medical Center). Upon completion of the baseline evaluation, the project coordinator will assign random assignment. The research assistants will be masked to random assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Headache Days at 3 Months
时间窗: 3 Months after Baseline
Daily self-reported migraine headaches using a VA text message protocol
Budget Impact Analysis - Cost of Training (Implementation)
时间窗: 2 years
Costs associated with program implementation
Budget Impact Analysis - Time
时间窗: 2 years
Time associated with program implementation
Budget Impact Analysis - Cost Per Veteran
时间窗: 2 years
Costs associated with intervention per Veteran
次要结局
未报告次要终点