TelemEdiciNe-bAsed Cognitive TherapY for Migraines (TENACITY)

TENACITY: TelemEdiciNe-bAsed Cognitive Therapy for Migraine

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.

Study Overview

• Status: Completed
• Conditions: Migraine Headache
• Intervention / Treatment: Behavioral: TENACITY Telehealth Cognitive Behavioral Therapy for Migraine; Behavioral: Behavioral Usual Care

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.

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 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Birmingham VA Medical Center, Birmingham, AL
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Indiana
    • Indianapolis, Indiana, United States, 46202-2884
      • Richard L. Roudebush VA Medical Center, Indianapolis, IN
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENACITY Telehealth Cognitive Behavioral Therapy for Migraine; Six sessions of standardized Cognitive Behavioral Therapy for patients with diagnosed chronic migraine headaches will be delivered by a clinical health psychologist via telehealth platform. All patients have access to a set of standardized educational, headache self-management materials.	Behavioral: TENACITY Telehealth Cognitive Behavioral Therapy for Migraine; Clinical health psychology therapy delivered via telehealth
Active Comparator: Behavioral Usual Care; Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW. Behavioral usual care will be delivered by clinicians for patients with diagnosed chronic migraine.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Headache Days in the 30 days Prior to 3-Month Mark	Daily self-reported migraine headaches using a VA text message protocol	30 days prior to 3-Month Outcomes after Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation fidelity to the core functions of TENACITY	Degree to which the core components of TENACITY are delivered as intended	3 months
Budget Impact Analysis	Costs associated with program implementation	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine-Specific Quality of Life Questionnaire (MSQ)	Self-reported migraine related functioning	3 and 6 months
Migraine Disability Assessment (MIDAS)	Self-reported disability due to migraines	3 and 6 months
Headache-specific Pain Catastrophizing Scale (HPCS)	Self-reported headache pain	3 and 6 months
Headache Management Self-Efficacy Scale (HMSE)	Self-reported confidence to manage headaches	3 and 6 months
Personal Health Inventory short form	Self-reported health	3 and 6 months
PCL-5 (PTSD Checklist for DSM-5)	Self-reported PTSD symptoms	3 and 6 months
Patient Health Questionnaire - PHQ-9	Self-reported depressive symptoms	3 and 6 months
Generalized Anxiety Disorder (GAD-7)	Self-reported anxiety symptoms	3 and 6 months
Veterans RAND 12 (VR-12)	Self-reported functioning and well-being	3 and 6 months
Insomnia Severity Index (ISI)	Self-reported sleep disruptions	3 and 6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Teresa M. Damush, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Publications and helpful links

General Publications

• 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.
• 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 Sep 13;99(18):e1979-92. doi: 10.1212/WNL.0000000000200888. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Telehealth; Cognitive Behavioral Therapy; Implementation Science
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: IRP 20-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study completion and the planned and secondary analyses are published by the study team, a limited de-identified data set will be made available upon request for a limited period.
• IPD Sharing Time Frame: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No