Healthy Living Partnerships for Veterans With Migraine

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• W.G. Bill Hefner Medical Center

  collaborator FED

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Mara Vitolins, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-30

Primary Completion

2026-06-30

Completion

2026-06-30