Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: AIM 4
WithdrawnNot applicableNCT03465826
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: Testing Feasibility, Acceptability, and Utility, AIM 4
- Conditions
- Interventions
- Behavioral: PainCOACH Pain Coping Skills Training
- Behavioral: Treatment as Usual
- Sponsor
- Wake Forest University Health Sciences
- Collaborators
- Duke University; Northwestern University
- Start date
- 2022-05-01
- Primary completion
- 2026-04-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 18 years old or older * Chronic migraine (diagnosed as 15 or more headaches per month) * Willing and able to provide consent * Able to speak and read English Exclusion Criteria: * headache disorder other than migraine * change in preventive medications within 3 weeks prior to enrollment * pain disorder other than migraine as a primary problem * pregnant or planning pregnancy * medical or psychiatric comorbidities likely to interfere with participation * less than 7th grade reading proficiency
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03465826