Migraine HeadacheTENACITYNCT04613362

TelemEdiciNe-bAsed Cognitive TherapY for Migraines

A study testing TENACITY Telehealth Cognitive Behavioral Therapy for Migraine in people with Migraine Headache, run by VA Office of Research and Development at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine Headache
What is being tested?: TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 4 sitesUnited States
Study dates: 22 Apr 2021to 31 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Show all 19Show fewer

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Migraine Headache
Being tested: TENACITY Telehealth Cognitive Behavioral Therapy for Migraine, Behavioral Usual Care
Keywords: Implementation Science, Telehealth, Cognitive Behavioral Therapy
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04613362
Study group	Role	What they receive
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine	Experimental	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. Receives: Behavioral: TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
Behavioral Usual Care	Active comparator	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. Receives: Behavioral: Behavioral Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Headache Days at 3 Months
Daily self-reported migraine headaches using a VA text message protocol
Measured: 3 Months after Baseline
Budget Impact Analysis - Cost of Training (Implementation)
Costs associated with program implementation
Measured: 2 years
Budget Impact Analysis - Time
Time associated with program implementation
Measured: 2 years
Budget Impact Analysis - Cost Per Veteran
Costs associated with intervention per Veteran
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 202131 May 2023

First posted3 Nov 2020
Study start22 Apr 2021
Primary completion29 Apr 2023
Study completion31 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Migraine HeadacheStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04613362
Sponsor's protocol ID: IRP 20-002
Acronym: TENACITY
Status last verified: Aug 2024
First submitted: 27 Oct 2020
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

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.
PubMed 35293614
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.
PubMed 36100439
Damush TM, Calcatera SM, Datre O, Hayley L, Austin C, Schlitz EL, Eubanks CL, Harrison L, Yuan D, Taylor S, Flanagan M, Ney J, Seng EK, Sico JJ, Grinberg AS. Telemedicine-based cognitive behavioral therapy (TENACITY) for Veterans with chronic migraine: A pilot randomized controlled trial protocol. Cephalalgia Rep. 2025 Sep 1;8:10.1177/25158163251374156. doi: 10.1177/25158163251374156.
PubMed 42266645

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
Not yet recruiting
Laser Acupuncture for Chronic Migraine: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Function
Chronic Migraine Headache
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
Not yet recruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine

All Migraine Headache trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TENACITY: TelemEdiciNe-bAsed Cognitive Therapy for Migraine
ClinicalTrials.gov ID: NCT04613362
Acronym / sponsor ID: TENACITY / IRP 20-002
Conditions: Migraine Headache
Keywords: Implementation Science, Telehealth, Cognitive Behavioral Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 22 Apr 2021 (actual)
Primary completion: 29 Apr 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 3 Nov 2020 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The specific aims are threefold:

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

Hypothesis 3: TENACITY will be cost-effective and provide value to Veterans and VHA.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine	Experimental	Behavioral: TENACITY Telehealth Cognitive Behavioral Therapy for MigraineSix 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 Usual Care	Active comparator	Behavioral: Behavioral Usual CareBehavioral 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (19 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TENACITY Telehealth Cognitive Behavioral Therapy for MigraineClinical health psychology therapy delivered via telehealth	Behavioural	TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
Behavioral Usual CareBehavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.	Behavioural	Behavioral Usual Care

Primary outcome

Number of Headache Days at 3 Months
Time frame: 3 Months after Baseline
Daily self-reported migraine headaches using a VA text message protocol
Budget Impact Analysis - Cost of Training (Implementation)
Time frame: 2 years
Costs associated with program implementation
Budget Impact Analysis - Time
Time frame: 2 years
Time associated with program implementation
Budget Impact Analysis - Cost Per Veteran
Time frame: 2 years
Costs associated with intervention per Veteran

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine	30	30
Behavioral Usual Care	27	27

Primary outcome: Number of Headache Days at 3 Months

Time frame: 3 Months after Baseline. Mean (Standard Deviation). Unit: headache days

Measure	TENACITY Telehealth Cognitive Behavioral Therapy for Migraine n = 30	Behavioral Usual Care n = 27
Baseline	18.17 (7.82)	19.19 (8.54)
3 months	16.47 (10.17)	18.26 (11.05)

TENACITY Telehealth Cognitive Behavioral Therapy for Migraine vs Behavioral Usual Care: Odds Ratio (OR): 0.82 (95% CI 0.34 to 1.97), p = 0.61, Mixed Models Analysis

Primary outcome: Budget Impact Analysis - Cost of Training (Implementation)

Time frame: 2 years. Number. Unit: dollars

Measure	TENACITY Telehealth Cognitive Behavioral Therapy for Migraine n = 30	Behavioral Usual Care n = 27
Value	12020.99	271.57

Population analysed: Summary Costs

Primary outcome: Budget Impact Analysis - Time

Time frame: 2 years. Number. Unit: hours

Measure	TENACITY Telehealth Cognitive Behavioral Therapy for Migraine n = 30	Behavioral Usual Care n = 27
Value	201.1	4.0

Population analysed: Summary Time (hours of training)

Primary outcome: Budget Impact Analysis - Cost Per Veteran

Time frame: 2 years. Mean (Standard Deviation). Unit: dollars

Measure	TENACITY Telehealth Cognitive Behavioral Therapy for Migraine n = 30	Behavioral Usual Care n = 27
Value	194.46 (107.47)	113.52 (210.40)

Population analysed: Summary Costs

Adverse events

Time frame: Adverse event data were collected up to 7 months after participants started treatment which was the end of the study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine	1 of 30 (3.3%)	13 of 30 (43.3%)	0 of 30
Behavioral Usual Care	3 of 27 (11.1%)	10 of 27 (37%)	0 of 27

Limitations and caveats (from the sponsor): Limitations include not reaching the target number of participants needed to achieve sufficient statistical power. We initially consented 80 participants of which 57 of the 80 were eligible to be randomized based on the 30 day headache diary outcomes confirming chronic headache. The study was conducted during the COVID-19 pandemic. Thus, the enhanced headache usual treatment was often offered via telehealth.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35293614Goldman 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.
Results publication: PubMed 36100439Seng 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.
Derived from this study: PubMed 42266645Damush TM, Calcatera SM, Datre O, Hayley L, Austin C, Schlitz EL, Eubanks CL, Harrison L, Yuan D, Taylor S, Flanagan M, Ney J, Seng EK, Sico JJ, Grinberg AS. Telemedicine-based cognitive behavioral therapy (TENACITY) for Veterans with chronic migraine: A pilot randomized controlled trial protocol. Cephalalgia Rep. 2025 Sep 1;8:10.1177/25158163251374156. doi: 10.1177/25158163251374156.
Individual participant dataSharing planned: Yes. 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.

Related trials for Migraine Headache

RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
Not yet recruiting
Laser Acupuncture for Chronic Migraine: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Function
Chronic Migraine Headache
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
Not yet recruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
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Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Teresa M. Damush, PhD principal investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TENACITY Telehealth Cognitive Behavioral Therapy for Migraine in people with Migraine Headache, run by VA Office of Research and Development at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Headache Days at 3 Months (time frame: 3 Months after Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04613362, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.