N/A
N=57
TelemEdiciNe-bAsed Cognitive TherapY for Migraines
Migraine Headache
Bottom Line
View on ClinicalTrials.gov: NCT04613362 ↗Enrolled (actual)
57
Serious AEs
7.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Headache Days at 3 Months — 18.17; 19.19; 16.47; 18.26 headache days — p=0.61
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TENACITY Telehealth Cognitive Behavioral Therapy for Migraine (Behavioral); Behavioral Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Headache Days at 3 Months |
18.17; 19.19; 16.47; 18.26 | 0.61 |
| PRIMARY Budget Impact Analysis - Cost of Training (Implementation) |
12020.99; 271.57 | — |
| PRIMARY Budget Impact Analysis - Time |
201.1; 4.0 | — |
| PRIMARY Budget Impact Analysis - Cost Per Veteran |
194.46; 113.52 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04613362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.