Chronic Migraine, HeadacheNCT03465826
Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: AIM 4
A study testing PainCOACH Pain Coping Skills Training and Treatment as Usual in people with Chronic Migraine, Headache, run by Wake Forest University Health Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine, Headache
- What is being tested?
- PainCOACH Pain Coping Skills Training and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: Testing Feasibility, Acceptability, and Utility, AIM 4
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.
Read the 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.
- Conditions
- Chronic Migraine, Headache
- Being tested
- PainCOACH Pain Coping Skills Training, Treatment as Usual
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainCOACH Pain Coping Skills TrainingBehavioural
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 as UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Through study completion, an average of 9 months
Secondary outcomes (6)
Change in Migraine Disability
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.
Measured: Baseline, 2 months, 5 months, and 8 months
Change in HIT-6
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
Measured: Baseline, 2 months, 5 months, and 8 months
Change in pain intensity
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.
Measured: Baseline, 2 months, 5 months, and 8 months
Change in headache management self-efficacy
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.
Measured: Baseline, 2 months, 5 months, and 8 months
Change in headache locus of control scale
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.
Measured: Baseline, 2 months, 5 months, and 8 months
Change in pain catastrophizing
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.
Measured: Baseline, 2 months, 5 months, and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 May 2022 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine, HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Northwestern University
- Responsible party
- Sponsor
- Investigators
- Donald B Penzien, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465826
- Sponsor's protocol ID
- 18-01218
- Status last verified
- Mar 2021
- First submitted
- 2 Feb 2018
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: Testing Feasibility, Acceptability, and Utility, AIM 4
- ClinicalTrials.gov ID
- NCT03465826
- Acronym / sponsor ID
- 18-01218
- Conditions
- Chronic Migraine, Headache
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Duke University, Northwestern University
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PainCOACH Pain Coping Skills Training | Experimental | Behavioral: PainCOACH Pain Coping Skills TrainingMigraineurs 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 as Usual | Active comparator | Behavioral: Treatment as UsualParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PainCOACH Pain Coping Skills TrainingMigraineurs 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. | Behavioural | PainCOACH Pain Coping Skills Training |
| Treatment as UsualParticipants 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. | Behavioural | Treatment as Usual |
Primary outcome
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".
6 secondary outcomes
Change in Migraine Disability
Time frame: Baseline, 2 months, 5 months, and 8 months
Change in HIT-6
Time frame: Baseline, 2 months, 5 months, and 8 months
Change in pain intensity
Time frame: Baseline, 2 months, 5 months, and 8 months
Change in headache management self-efficacy
Time frame: 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
Change in pain catastrophizing
Time frame: Baseline, 2 months, 5 months, and 8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald B Penzien, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing PainCOACH Pain Coping Skills Training and Treatment as Usual in people with Chronic Migraine, Headache, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Engagement (time frame: Through study completion, an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.