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Testing myWHI: Online Self-guided Programs for Migraine

This study is currently recruiting participants.
Verified March 2016 by Anna Huguet, IWK Health Centre
Sponsor:
ClinicalTrials.gov Identifier:
NCT02710942
First Posted: March 17, 2016
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Anna Huguet, IWK Health Centre
  Purpose
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).

Condition Intervention
Migraine Headache Behavioral: SPHERE Behavioral: PRISM

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Testing the Feasibility of Two Self-guided Web-based Interventions for Adolescents and Young Adults With Migraine: A Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Anna Huguet, IWK Health Centre:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • Proportion of randomized participants who drop out [ Time Frame: 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 ]
  • 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.

  • Proportion of randomized participants who complete the 4-month post-randomization assessment [ Time Frame: 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 ]
  • 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 ]
  • Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews [ Time Frame: 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 ]

Estimated Enrollment: 60
Study Start Date: March 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710942


Contacts
Contact: Anna Huguet, PhD 902.470.7521 anna.huguet@iwk.nshealth.ca

Locations
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Anna Huguet, PhD       anna.huguet@iwk.nshealth.ca   
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Anna Huguet, PhD IWK Health Centre
  More Information

Additional Information:
Responsible Party: Anna Huguet, Research Scientist, IWK Health Centre
ClinicalTrials.gov Identifier: NCT02710942     History of Changes
Other Study ID Numbers: PSO-EST-2014-9575
First Submitted: November 12, 2015
First Posted: March 17, 2016
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms