TelemEdiciNe-bAsed Cognitive TherapY for Migraines

NCT04613362 | Completed Results DMC

• 1 other identifier: IRP 20-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Migraine Headache

Keywords

Implementation Science; Telehealth; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (4)

• Number of Headache Days at 3 Months

  Daily self-reported migraine headaches using a VA text message protocol

  3 Months after Baseline

• Budget Impact Analysis - Cost of Training (Implementation)

  Costs associated with program implementation

  2 years

• Budget Impact Analysis - Time

  Time associated with program implementation

  2 years

• Budget Impact Analysis - Cost Per Veteran

  Costs associated with intervention per Veteran

  2 years

Other Outcomes (9)

• Migraine-Specific Quality of Life Questionnaire (MSQ)

  3 months, 6 months

• Migraine Disability Assessment (MIDAS)

  3 and 6 months

• Headache-specific Pain Catastrophizing Scale (HPCS)

  3 and 6 months

Study Arms (2)

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.

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.

Behavioral: Behavioral Usual Care

Interventions

TENACITY Telehealth Cognitive Behavioral Therapy for Migraine BEHAVIORAL

Clinical health psychology therapy delivered via telehealth

TENACITY Telehealth Cognitive Behavioral Therapy for Migraine

Behavioral Usual Care BEHAVIORAL

Behavioral usual care may include outpatient clinic-based health psychology in the VA or Community Care, or mindfulness sessions with LCSW.

Behavioral Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

Related 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 Mar;62(3):306-318. doi: 10.1111/head.14277. Epub 2022 Mar 16.

  PMID: 35293614 RESULT

• 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.

  PMID: 36100439 RESULT

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Teresa Damush
• Organization: Richard L. Roudebush VA Medical Center

teresa.damush@va.gov

317-988-4277

Study Officials

• Teresa M. Damush, PhD

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant will be randomized by mode of delivery to the telehealth or TAU 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 3, 2020
• Study Start: April 22, 2021
• Primary Completion: April 29, 2023
• Study Completion: May 31, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: To be determined

Locations

US (4)