- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465826
Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: AIM 4
Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: Testing Feasibility, Acceptability, and Utility, AIM 4
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and Engagement
Time Frame: Through study completion, an average of 9 months
|
"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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Migraine Disability
Time Frame: Baseline, 2 months, 5 months, and 8 months
|
The MIDAS (NINDS CDE 2.0 "highly recommended") was developed to assess headache-related disabilities focusing on care for persons with migraine [[Stewart 2000, 2001]].
Headache sufferers answer 5 questions (self-administered) related to the last 3 months, indicating the number of days their everyday life has been limited by migraines.
MIDAS assesses disability in 3 areas: a) household work, b) paid work and/or school, and c) social, leisure, and family activities.
MIDAS is valuable for quantification of headache disability and as a reference for measuring improvement.
The MIDAS is widely employed, internally consistent, highly reliable, valid, and correlates with physicians' clinical judgments.
The instrument usually takes less than 5 minutes to complete and is easy to understand.
|
Baseline, 2 months, 5 months, and 8 months
|
Change in HIT-6
Time Frame: Baseline, 2 months, 5 months, and 8 months
|
The HIT-6 (NINDS CDE 2.0 "highly recommended") is a 6-question self-report tool that measures the impact headaches have on a person's ability to function on the job, at home, at school, and in social situations, with items that address a spectrum of health outcomes (ranging from pain to emotional distress)81,82.
The HIT-6 is widely use and well validated, and employs a recall period of 4 weeks
|
Baseline, 2 months, 5 months, and 8 months
|
Change in pain intensity
Time Frame: Baseline, 2 months, 5 months, and 8 months
|
The Pain NRS (Numeric Rating Scale) will be used to assess pain intensity and to facilitate comparison of findings across trials examining PainCOACH.
Specifically, patients are asked to rate average, worst, and least levels of pain intensity over the past week on a scale with ratings ranging from 0 "no pain" to 10 "worst possible pain."
Minimally, moderately, and substantially important clinical change are represented by a decrease in score by 10% to 20%, >=30%, and >=50%, respectively80.
The Pain NRS has been validated as a treatment outcome measure and is recommended as a core outcome measure of clinical trials in chronic pain patients at the IMPAACT-II consensus meeting.
|
Baseline, 2 months, 5 months, and 8 months
|
Change in headache management self-efficacy
Time Frame: Baseline, 2 months, 5 months, and 8 months
|
The HMSE (Headache Management Self-Efficacy scale) is a 25-item headache-specific measure of self-efficacy employing Likert-type rating scale ranging from 1 to 7 with questions in order to quantify headache patients' confidence in their own ability to prevent and manage headache attacks.
The HMSE is established as both reliable and valid.
|
Baseline, 2 months, 5 months, and 8 months
|
Change in headache locus of control scale
Time Frame: Baseline, 2 months, 5 months, and 8 months
|
The HSLC (Headache-Specific Locus of Control Scale) is a 33-item self-report questionnaire designed specifically for recurrent headache sufferers to assess the individual's perceptions that headache problems and headache relief are determined primarily by the individual's behavior (Internal Locus of Control), the actions of health care professionals (Health Care Professionals Locus of Control), or chance factors (Chance Locus of Control).
The Likert-type item responses range from 1 (strongly disagree) to 5 (strongly agree).
Factor analysis confirmed the 3-factor structure of the HSLC, and the reliability of the subscales is established (Cronbach ́s α of .86,
.84 and .88 for each factor, respectively) and confirmed.
|
Baseline, 2 months, 5 months, and 8 months
|
Change in pain catastrophizing
Time Frame: Baseline, 2 months, 5 months, and 8 months
|
The PCS (Pain Catastrophizing Scale) is a 13-item self-report measure of the tendency to ruminate, magnify, or feel hopeless about, that is, catastrophize about pain.
Each item is rated on a 5-point scale ranging from 0 "not at all" to 4 "all the time," with a total summed scale score ranging from 0 to 52.
A score of >=30 is suggestive of clinically relevant levels of catastrophizing.
The PCS was administered at the beginning of each session.
|
Baseline, 2 months, 5 months, and 8 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Donald B Penzien, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-01218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Migraine, Headache
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Assiut UniversityRecruitingChronic Migraine | Chronic Migraine, HeadacheEgypt
-
Kanuni Sultan Suleyman Training and Research HospitalCompleted
-
Milton S. Hershey Medical CenterTerminatedChronic Migraine, HeadacheUnited States
-
University of SaskatchewanSaskatchewan Health Research FoundationNot yet recruiting
-
Universidad Autonoma de MadridCompletedChronic Migraine | Chronic HeadacheSpain
-
Children's Hospital of PhiladelphiaNational Institute of Neurological Disorders and Stroke (NINDS)Completed
-
MedtronicNeuroCompletedChronic Migraine HeadacheUnited States, Canada, United Kingdom
-
AbbVieActive, not recruitingChronic Migraine | Episodic MigraineUnited States, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Spain, Taiwan, United Kingdom
-
AbbVieActive, not recruitingChronic Migraine | Episodic MigraineJapan
Clinical Trials on PainCOACH Pain Coping Skills Training
-
Duke UniversityCompletedPCST-Full (Pain Coping Skills Training) | PCST-BriefUnited States
-
Duke UniversityCompletedMobile Pain Coping Skills Training | In Person Pain Coping Skills TrainingUnited States
-
Duke UniversityCompletedStem Cell TransplantUnited States
-
University of North Carolina, Chapel HillPatient-Centered Outcomes Research InstituteCompletedOsteoarthritisUnited States
-
Duke UniversityAmerican Cancer Society, Inc.RecruitingPain | Advanced Solid TumorUnited States
-
Duke UniversityIcahn School of Medicine at Mount SinaiCompleted
-
Wake Forest University Health SciencesHonorHealth Research InstituteRecruitingCIPN - Chemotherapy-Induced Peripheral NeuropathyUnited States
-
Duke UniversityRecruitingBreast CancerUnited States
-
Virginia Commonwealth UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedKnee OsteoarthritisUnited States
-
Northwestern UniversityNational Cancer Institute (NCI); Duke UniversityRecruitingBreast Cancer | Arthralgia | Pain, ChronicUnited States