TelemEdiciNe-bAsed Cognitive TherapY for Migraines (TENACITY)
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| ClinicalTrials.gov Identifier: NCT04613362 |
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Recruitment Status :
Recruiting
First Posted : November 3, 2020
Last Update Posted : January 20, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine Headache | Behavioral: TENACITY Telehealth Cognitive Behavioral Therapy for Migraines Behavioral: Usual Care Outpatient Cognitive Behavioral Therapy for Migraines Face to Face | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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 outpatient CBT delivered face to face at the VA medical center plus education. |
| Masking: | Double (Participant, Outcomes Assessor) |
| Masking Description: | The participant will be randomized by mode of delivery to the telehealth or the outpatient, in person CBT 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. To ensure adequate representation from female Veterans, we will oversample and stratify by female Veterans. |
| Primary Purpose: | Health Services Research |
| Official Title: | TENACITY: TelemEdiciNe-bAsed Cognitive Therapy for Migraine |
| Actual Study Start Date : | December 1, 2020 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | June 20, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: TENACITY Telehealth Cognitive Behavioral Therapy
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.
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Behavioral: TENACITY Telehealth Cognitive Behavioral Therapy for Migraines
Clinical health psychology therapy delivered via telehealth |
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Active Comparator: Usual Care Outpatient Cognitive Behavioral Therapy Face to Fa
Usual care Cognitive Behavioral Therapy will be delivered by clinical health psychologists for patients with diagnosed chronic migraines face to face at the VAMC outpatient clinics. All patients have access to a set of standardized educational, headache self-management materials.
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Behavioral: Usual Care Outpatient Cognitive Behavioral Therapy for Migraines Face to Face
Clinical health psychology therapy delivered face to face at VA Medical Center outpatient clinic |
- Number of Headache Days in the 30 days Prior to 3-Month Mark [ Time Frame: 30 days prior to 3-Month Outcomes after Baseline ]Daily self-reported migraine headaches using a VA text message protocol
- Implementation fidelity to the core functions of TENACITY [ Time Frame: 3 months ]Degree to which the core components of TENACITY are delivered as intended
- Budget Impact Analysis [ Time Frame: 2 years ]Costs associated with program implementation
- Headache Triggers Sensitivity and Avoidance Questionnaire (HTSAQ) [ Time Frame: 3 and 6 months ]Self-reported headache triggers
- Migraine-Specific Quality of Life Questionnaire (MSQ) [ Time Frame: 3 and 6 months ]Self-reported migraine related functioning
- Migraine Disability Assessment (MIDAS) [ Time Frame: 3 and 6 months ]Self-reported disability due to migraines
- Headache-specific Pain Catastrophizing Scale (HPCS) [ Time Frame: 3 and 6 months ]Self-reported headache pain
- Headache Management Self-Efficacy Scale (HMSE) [ Time Frame: 3 and 6 months ]Self-reported confidence to manage headaches
- The Chronic Pain Acceptance Questionnaire (CPAQ) [ Time Frame: 3 and 6 months ]Self-reported chronic pain
- Personal Health Inventory short form [ Time Frame: 3 and 6 months ]Self-reported health
- Perceived Stress Scale [ Time Frame: 3 and 6 months ]4 items on self-reported current perceived stress
- PTSD Checklist-5 [ Time Frame: 3 and 6 months ]PCL-5 5 items on PTSD symptoms
- Patient Health Questionnaire - PHQ8 [ Time Frame: 3 and 6 months ]Self-reported depressive symptoms
- Generalized Anxiety Disorder (GAD-7) [ Time Frame: 3 and 6 months ]Self-reported anxiety symptoms
- Veterans Rand 12 Items HRQo L [ Time Frame: 3 and 6 months ]VR - 12 self-reported functioning and well-being
- Insomnia Severity Index (ISI) [ Time Frame: 3 and 6 months ]Self-reported sleep disruptions
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613362
| Contact: Teresa M Damush, PhD | (317) 201-3661 | Teresa.Damush@va.gov | |
| Contact: Samantha Calcatera, PhD BS | samantha.calcatera@va.gov |
| United States, Alabama | |
| Birmingham VA Medical Center, Birmingham, AL | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Emily L Schlitz, MD Lane.schlitz@gmail.com | |
| United States, Connecticut | |
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Recruiting |
| West Haven, Connecticut, United States, 06516 | |
| Contact: Jason Sico, MD jason.sico@va.gov | |
| United States, Indiana | |
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Recruiting |
| Indianapolis, Indiana, United States, 46202-2884 | |
| Contact: Angela L Rollins, PhD 317-679-0434 Angela.Rollins@va.gov | |
| Contact: Linda A Collins, BS CRA (317) 988-2722 linda.collins4@va.gov | |
| Principal Investigator: Teresa M. Damush, PhD | |
| United States, Texas | |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Paul Hurd, MD paul.hurd@va.gov | |
| Principal Investigator: | Teresa M. Damush, PhD | Richard L. Roudebush VA Medical Center, Indianapolis, IN |
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT04613362 |
| Other Study ID Numbers: |
IRP 20-002 |
| First Posted: | November 3, 2020 Key Record Dates |
| Last Update Posted: | January 20, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Time Frame: | To be determined |
| 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 |
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Implementation Science Telehealth Cognitive Behavioral Therapy |
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Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations |