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

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Chronic Migraine, Headache

Treatments: Behavioral: Treatment as Usual; Behavioral: PainCOACH Pain Coping Skills Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03465826

18-01218

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

PainCOACH Pain Coping Skills Training

Experimental group

Description:

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.

Treatment:

Behavioral: PainCOACH Pain Coping Skills Training

Treatment as Usual

Active Comparator group

Description:

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.

Treatment:

Behavioral: Treatment as Usual