NCT04373330

Healthy Living Partnerships for Veterans With Migraine

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot study, modeled upon the successful and empirically validated HELP Prevent Diabetes Intervention, incorporates a migraine education component describing the links between lifestyle behaviors and migraine activity (e.g., frequency, impairment) into an existing lifestyle intervention used previously for Veterans at risk for developing Type II diabetes. The principal objectives of this research are to assess the feasibility, acceptability (recruitment), engagement (retention, adherence), and promise of implementing the HELP-VM at the Salisbury. To achieve our objectives, the investigators propose to assess the acceptability of HELP-VM by determining our ability to recruit Veterans to participate in the HELP-VM intervention as administered through the existing structure of the Salisbury VAMC's Whole Health Program, to evaluate the feasibility of implementing HELP-VM by assessing Veterans' adherence to HELP-VM and our capacity to retain them in a clinical trial, and to evaluate the promise of HELP-VM by obtaining preliminary data to estimate variances of primary (headache frequency, headache-related impairment) and secondary/exploratory outcome measures (e.g., emotional distress, use of analgesics/opiates, headache self-efficacy, pain catastrophizing) to inform a future, large-scale trial.

Detailed description

Headache disorders such as migraine occur commonly among Veterans and contribute to disability and reduced quality of life. Veterans with migraine are more likely than those without headache to experience medically related discharge/retirement, post-traumatic stress disorder, sleep disturbances, and difficulty reintegrating back into civilian life. Despite advances in our understanding of migraine, it remains poorly understood and often proves refractory to validated drug and non-drug interventions. Therefore, there is tremendous potential value in pursuing alternate intervention pathways for migraine management. Although empirical support remains limited, engagement in regular exercise routinely is recommended for managing and preventing migraine. This innovative approach, if successful, could be disseminated rapidly to the VAMC in the United States, thereby making a substantial impact on the public health burden of migraine and other lifestyle related chronic diseases amongst our nation's Veterans. Consistent with the VA's Whole Health Initiative, this HELP-VM approach facilitates and supports Veterans' capacity to take charge of their own health and well-being, and recognizes the many health benefits of reducing sedentary activity for migraine and beyond.

Conditions

• Migraine
• Migraine Disorders
• Migraine With Aura
• Migraine Without Aura

Interventions

Type	Name	Description
BEHAVIORAL	Intensive Lifestyle Intervention	There will be 14 sessions delivered over the course of 6 months; materials consist of CHW lesson plans, participant workbooks, and the DVD series. These materials will be adapted for use in HELP-VM and will include information on migraine and its management as well as mental health resources available to Veterans for common illnesses like depression and post-traumatic stress disorder and modifying physical activity recommendations for Veterans with limited mobility.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-05-04
• Last updated: 2025-07-02