TENACITY Telehealth Cognitive Behavioral Therapy for Migraines for Migraine

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Migraine+2 More
TENACITY Telehealth Cognitive Behavioral Therapy for Migraines - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new therapy delivered by telehealth for Veterans with chronic migraines. The hope is that this will be an effective and more accessible way to provide care for this population.

Eligible Conditions
  • Migraine

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 2 years

2 years
Budget Impact Analysis
3 and 6 months
Generalized Anxiety Disorder (GAD-7)
Headache Management Self-Efficacy Scale (HMSE)
Headache Triggers Sensitivity and Avoidance Questionnaire (HTSAQ)
Headache-specific Pain Catastrophizing Scale (HPCS)
Insomnia Severity Index (ISI)
Migraine Disability Assessment (MIDAS)
Migraine-Specific Quality of Life Questionnaire (MSQ)
PCL-5 (PTSD Checklist for DSM-5)
PTSD Checklist-5
Patient Health Questionnaire - PHQ-9
Patient Health Questionnaire - PHQ8
Perceived Stress Scale
Personal Health Inventory short form
The Chronic Pain Acceptance Questionnaire (CPAQ)
Veterans RAND 12 (VR-12)
Veterans Rand 12 Items HRQo L
3 months
Implementation fidelity to the core functions of TENACITY
Day 30
Number of Headache Days in the 30 days Prior to 3-Month Mark

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Usual Care Outpatient Cognitive Behavioral Therapy Face to Face
1 of 5
Usual Care Outpatient Cognitive Behavioral Therapy Face to Fa
1 of 5
Behavioral Usual Care
1 of 5
TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
1 of 5
TENACITY Telehealth Cognitive Behavioral Therapy
1 of 5
Active Control
Experimental Treatment

80 Total Participants · 5 Treatment Groups

Primary Treatment: TENACITY Telehealth Cognitive Behavioral Therapy for Migraines · No Placebo Group · N/A

TENACITY Telehealth Cognitive Behavioral Therapy for Migraine
Behavioral
Experimental Group · 1 Intervention: TENACITY Telehealth Cognitive Behavioral Therapy for Migraine · Intervention Types: Behavioral
TENACITY Telehealth Cognitive Behavioral Therapy
Behavioral
Experimental Group · 1 Intervention: TENACITY Telehealth Cognitive Behavioral Therapy for Migraines · Intervention Types: Behavioral
Usual Care Outpatient Cognitive Behavioral Therapy Face to Face
Behavioral
ActiveComparator Group · 1 Intervention: Usual Care Outpatient Cognitive Behavioral Therapy for Migraines Face to Face · Intervention Types: Behavioral
Usual Care Outpatient Cognitive Behavioral Therapy Face to Fa
Behavioral
ActiveComparator Group · 1 Intervention: Usual Care Outpatient Cognitive Behavioral Therapy for Migraines Face to Face · Intervention Types: Behavioral
Behavioral Usual Care
Behavioral
ActiveComparator Group · 1 Intervention: Behavioral Usual Care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,472 Previous Clinical Trials
2,741,614 Total Patients Enrolled
Teresa M. Damush, PhDPrincipal InvestigatorRichard L. Roudebush VA Medical Center, Indianapolis, IN
3 Previous Clinical Trials
438 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a chronic migraine headache.
You have completed at least 28 headache diary days.
You have a confirmed frequency of at least 8 headache days per month.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.