TelemEdiciNe-bAsed Cognitive TherapY for Migraines

Migraine Headache Clinical Trial

— TENACITY  

Official title:

TENACITY: TelemEdiciNe-bAsed Cognitive Therapy for Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613362
• Other study ID #: IRP 20-002
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Behavioral:
• TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
Clinical health psychology therapy delivered via telehealth
• Behavioral Usual Care
Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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 Sep 13;99(18):e1979-92 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Migraine-Specific Quality of Life Questionnaire (MSQ)	Self-reported migraine related functioning	3 and 6 months
Other	Migraine Disability Assessment (MIDAS)	Self-reported disability due to migraines	3 and 6 months
Other	Headache-specific Pain Catastrophizing Scale (HPCS)	Self-reported headache pain	3 and 6 months
Other	Headache Management Self-Efficacy Scale (HMSE)	Self-reported confidence to manage headaches	3 and 6 months
Other	Personal Health Inventory short form	Self-reported health	3 and 6 months
Other	PCL-5 (PTSD Checklist for DSM-5)	Self-reported PTSD symptoms	3 and 6 months
Other	Patient Health Questionnaire - PHQ-9	Self-reported depressive symptoms	3 and 6 months
Other	Generalized Anxiety Disorder (GAD-7)	Self-reported anxiety symptoms	3 and 6 months
Other	Veterans RAND 12 (VR-12)	Self-reported functioning and well-being	3 and 6 months
Other	Insomnia Severity Index (ISI)	Self-reported sleep disruptions	3 and 6 months
Primary	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	Implementation fidelity to the core functions of TENACITY	Degree to which the core components of TENACITY are delivered as intended	3 months
Secondary	Budget Impact Analysis	Costs associated with program implementation	2 years