Clinical trial NCT04613362: TelemEdiciNe-bAsed Cognitive TherapY for Migraines
Official title: TENACITY: TelemEdiciNe-bAsed Cognitive Therapy for Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Headache
Keywords: Implementation Science
Telehealth
Cognitive Behavioral Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-11-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled feasibility pilot with a single intervention arm, and a usual care control arm. The intervention arm includes participation in the TENACITY telehealth cognitive behavioral therapy CBT program for headache plus education. The usual care arm includes behavioral treatment as usual which may include outpatient clinic-based health psychology in the VA or in the community, or mindfulness sessions by LCSW.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Aim 2. To conduct a pilot RCT and determine the preliminary efficacy and feasibility of TENACITY compared to TAU across 3 VA 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.

Eligibility criteria: 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 at least 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;
* 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

Primary outcomes:
measure: Number of Headache Days at 3 Months
timeFrame: 3 Months after Baseline
measure: Budget Impact Analysis - Cost of Training (Implementation)
timeFrame: 2 years
measure: Budget Impact Analysis - Time
timeFrame: 2 years
measure: Budget Impact Analysis - Cost Per Veteran
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: Migraine-Specific Quality of Life Questionnaire (MSQ)
timeFrame: 3 months, 6 months
measure: Migraine Disability Assessment (MIDAS)
timeFrame: 3 and 6 months
measure: Headache-specific Pain Catastrophizing Scale (HPCS)
timeFrame: 3 and 6 months
measure: Headache Management Self-Efficacy Scale (HMSE)
timeFrame: 3 and 6 months
measure: PCL-5 (Post-Traumatic Stress Disorder Checklist)
timeFrame: Baseline
measure: Patient Health Questionnaire - PHQ-9
timeFrame: 3 and 6 months
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 3 and 6 months
measure: Veterans RAND 12 (VR-12)
timeFrame: 3 and 6 months
measure: Insomnia Severity Index (ISI)
timeFrame: 3 and 6 months
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center, Birmingham, AL
state: Alabama
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Teresa M. Damush, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldman RE, Damush TM, Kuruvilla DE, Lindsey H, Baird S, Riley S, Burrone Bs L, Grinberg AS, Seng EK, Fenton BT, Sico JJ. Essential components of care in a multidisciplinary headache center: Perspectives from headache neurology specialists. Headache. 2022 Mar;62(3):306-318. doi: 10.1111/head.14277. Epub 2022 Mar 16.
citation: Seng EK, Fenton BT, Wang K, Lipton RB, Ney J, Damush T, Grinberg AS, Skanderson M, Sico JJ. Frequency, Demographics, Comorbidities, and Health Care Utilization by Veterans With Migraine: A VA Nationwide Cohort Study. Neurology. 2022 Oct 31;99(18):e1979-e1992. doi: 10.1212/WNL.0000000000200888.