Clinical trial NCT03465826: Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: AIM 4
Official title: Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: Testing Feasibility, Acceptability, and Utility, AIM 4
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Migraine, Headache
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Duke University
name: Northwestern University
First posted: 2018-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: In addition to experiencing chronic pain, disability, and diminished quality of life, individuals with chronic migraine face critical access barriers to traditional, validated, clinic-based behavioral headache treatments (eg, availability of trained therapists, cost, absences from work). Internet-based and mHealth technologies show promise for the treatment of chronic pain conditions and are primed to address barriers to treatment, but have not yet been optimally translated into interventions for chronic migraine. A program of development is proposed to transform a validated, 8-week Internet-based pain-coping skills training (PCST) program (PainCOACH I; original) into a version specific for chronic migraine.

PainCOACH I was designed to retain key therapeutic components of in-clinic protocols and includes 8 modules of self-directed, tailored, interactive training in cognitive behavioral pain coping skills. A "virtual coach" provides verbal and visual instruction, feedback, and encouragement guided by theoretically-based learning principles. PainCOACH I has been successfully tested for populations with osteoarthritis and cancer pain, and has been studied in the US and Australia.

This clinical trial registration pertains only to Aim 4 of the study. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and Engagement
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
measure: Change in Migraine Disability
timeFrame: Baseline, 2 months, 5 months, and 8 months
measure: Change in HIT-6
timeFrame: Baseline, 2 months, 5 months, and 8 months
measure: Change in pain intensity
timeFrame: Baseline, 2 months, 5 months, and 8 months
measure: Change in headache management self-efficacy
timeFrame: Baseline, 2 months, 5 months, and 8 months
measure: Change in headache locus of control scale
timeFrame: Baseline, 2 months, 5 months, and 8 months
measure: Change in pain catastrophizing
timeFrame: Baseline, 2 months, 5 months, and 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Donald B Penzien, PhD
role: PRINCIPAL_INVESTIGATOR
References: