Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: AIM 4

Summary

This ClinicalTrials.gov record pertains only to the clinical trial described below in Aim 4. Aims 1-3 and 5 are described here as background information. This study will be a two-site collaborative research effort (Wake Forest \& Duke Univ.) drawing on expertise of investigators steeped in PCST, Internet-based treatment delivery, and development of cost-efficient and maximally-accessible behavioral interventions for migraine and chronic pain. This research will address four specific aims via a mixed-methods approach. In Aim 1 subjects (n=20) will be recruited to participate in user testing of the extant program (PainCOACH1). In Aim 2 subjects (n=64, including migraineurs, members of migraine patient advocacy groups, and clinical professionals trained in headache medicine) will participate in focus groups to provide guidance for appropriately tailoring the program for the treatment of chronic migraine. In Aim 3 feedback from Aims 1 and 2 will be employed to build and develop PainCOACH Migraine which will be beta-tested and refined. In Aim 4 subjects (n=144) will be recruited to participate in a randomized, controlled trial of the PainCOACH Migraine program (versus Medical Treatment as Usual) to demonstrate its feasibility, acceptability and engagement, and promise. Guided by findings from these aims a final exploratory aim will be conducted to optimize the program using prediction models to identify patients at risk for poor outcomes or attrition, and an adaptive therapeutic process targeting improved outcomes for such patients. Ultimately these research efforts will provide data and experience needed to support a subsequent large-scale and methodologically rigorous adaptive trial to test PainCOACH Migraine and enhance understanding of the potentials for Internet-based delivery of behavioral programs for individuals with chronic migraine.

Conditions

• Chronic Migraine, Headache

Interventions

BEHAVIORAL

PainCOACH Pain Coping Skills Training

Migraineurs will participate in 4 weeks of daily headache monitoring, baseline questionnaires, followed by 8 weeks of the PainCOACH migraine mHealth Pain Coping Skills Training program (developed by Drs. Keefe and Rini based on social cognitive theory and in-person pain coping therapy sessions). Following the 8 week mHealth intervention, participants will immediately complete post-treatment assessments and later will complete follow-up assessments at 3 and 6 months.

BEHAVIORAL

Treatment as Usual

Participants will keep headache diaries for 4 weeks, followed by baseline assessments + 8 weeks of daily headache monitoring (as a parallel to the PainCOACH intervention). Post-assessments will immediately follow, and participants later will complete follow-up assessments at 3 and 6 months.

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Donald B Penzien, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2026-04-30

Completion

2027-04-30