Testing myWHI: Online Self-guided Programs for Migraine

October 15, 2018 updated by: Anna Huguet, IWK Health Centre

Testing the Feasibility of Two Self-guided Web-based Interventions for Adolescents and Young Adults With Migraine: A Pilot Randomized Controlled Trial

The goal for this pilot study is to assess the acceptability of two online self-guided programs for migraines. The programs are part of the investigators' collection of "my Wireless Headache Interventions" (myWHI). The Specialized Program for Headache Reduction (SPHERE) is a program that teaches cognitive and behavioural skills/techniques to help manage headaches. The PeRsonalized Intervention for Self-Management of Migraine (PRISM) helps users to discover their headache triggers and provides recommendations for managing them. This pilot will also assess the feasibility of the study protocol to inform a full scale randomized controlled trial (RCT).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 14-35 years
  • fluent in the English language (i.e., speaking, reading and writing);
  • suffer from headaches for a minimum of one year
  • stable pattern of headache symptoms (e.g., headache frequency, severity, location of pain, symptoms associated with headache) for the past 6 months
  • suffer from migraine headaches as indicated with a score of 2 and above on the ID Migraine
  • use the Smartphone for activities other than texting and calling (e.g., email, Facebook)
  • have daily Internet access from their Smartphone
  • minimum of four headache days during 4 weeks of using an electronic headache diary

Exclusion Criteria:

  • health care professional has not ruled out any underlying medical condition related to their headaches (e.g., head trauma, meningitis)
  • are pregnant, planning to get pregnant (in the next 4 to 6 months), or breastfeeding
  • have an impairment which compromises their ability to give informed consent
  • having been diagnosed with psychosis and/or schizophrenia
  • they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: SPHERE intervention
It is a comprehensive self-guided Internet-based cognitive-behavioral therapy (CBT) that includes three components: (1) the myWHI diary. (2) 30 multi-media learning topics that the user is encouraged to go through in a sequential way. The topics contain education information and teach strategies to cope better with their headaches.
Behavioral: SPHERE
EXPERIMENTAL: PRISM intervention
It is a targeted self-guided Internet-based CBT intervention. PRISM was built upon the myWHI diary, an electronic headache diary. PRISM helps users discover their headache triggers by analyzing the inputted diary data using association rule mining. Once one or multiple headache triggers are identified the application uses an algorithm to provide the user with a few personalized recommendations to help them to cope with these triggers. The algorithm is based on the opinion of clinical experts (e.g., medical health professionals, psychologists). The user chooses recommendations to follow and sets goals in the application to follow them. To support the process, the application checks in with users about their goals and tracks goal completion.
Behavioral: PRISM
NO_INTERVENTION: Usual care
Participants can continue doing what they usually do to deal with their migraines.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average number of individuals who complete the online screening per month
Time Frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
After reaching our desired sample size for randomization
Proportion of recruited participants who are eligible for study entry
Time Frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
After reaching our desired sample size for randomization
Proportion of eligible participants who consent
Time Frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
After reaching our desired sample size for randomization
Proportion of consented participants who are randomized
Time Frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
After reaching our desired sample size for randomization
Proportion of randomized participants who drop out
Time Frame: At 4-month post-randomization
At 4-month post-randomization
Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically
Time Frame: At 4-month post-randomization
At 4-month post-randomization
Proportion of consented participants who complete the baseline assessment
Time Frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
After reaching our desired sample size for randomization
Proportion of randomized participants who complete the 4-month post-randomization assessment
Time Frame: At 4-month post-randomization
At 4-month post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the 8-item Client Satisfaction Questionnaire (CSQ-8)
Time Frame: At 4-mont post-randomization
At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the single-item Patients' Global Impression of Change Scale (PGIC)
Time Frame: At 4-mont post-randomization
At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews
Time Frame: At 4-mont post-randomization
At 4-mont post-randomization
Proportion of participants in the control group who show clinically significant improvement (50% or greater reduction) from baseline in number of headache days in the last 4 weeks
Time Frame: At 4-mont post-randomization
At 4-mont post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSO-EST-2014-9575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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