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

NCT03465826 | Withdrawn DMC

• 1 other identifier: 18-01218
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Migraine, Headache

Outcome Measures

Primary Outcomes (1)

• Feasibility and Engagement

  "Feasibility and Engagement" represent a single outcome measure that is measured using the PainCOACH Feasibility Questionnaire, which was developed by Co-Investigators Dr. Rini and Dr. Keefe for evaluating patients'experiences and satisfaction with PainCOACH. This measure has been used extensively in past and present studies conducted by their research teams and others. These instruments will be administered ONLY during the post-treatment assessment interval and includes both qualitative and quantitative survey items. Quantitative survey items will be scaled from 1 to 5 to indicate level of agreement, where "1" indicates "strong agreement" and "5" indicates "strong disagreement".

  Through study completion, an average of 9 months

Secondary Outcomes (6)

• Change in Migraine Disability

  Baseline, 2 months, 5 months, and 8 months

• Change in HIT-6

  Baseline, 2 months, 5 months, and 8 months

• Change in pain intensity

  Baseline, 2 months, 5 months, and 8 months

• Change in headache management self-efficacy

  Baseline, 2 months, 5 months, and 8 months

• Change in headache locus of control scale

  Baseline, 2 months, 5 months, and 8 months

Study Arms (2)

PainCOACH Pain Coping Skills Training

EXPERIMENTAL

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: PainCOACH Pain Coping Skills Training

Treatment as Usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual

Interventions

PainCOACH Pain Coping Skills Training BEHAVIORAL

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.

PainCOACH Pain Coping Skills Training

Treatment as Usual BEHAVIORAL

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 as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Duke University: collaborator
• Northwestern University: collaborator

MeSH Terms

Conditions

Headache

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald B Penzien, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: March 14, 2018
• Study Start: May 1, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share