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Completed

NCT Number: NCT02710942

Testing myWHI: Online Self-guided Programs for Migraine

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).

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Key information

Conditions

Migraine Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

14 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPHERE

Behavioral

PRISM

Behavioral

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Proportion of randomized participants who drop out

    Time frame: At 4-month post-randomization

  6. 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

  7. 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.

  8. Proportion of randomized participants who complete the 4-month post-randomization assessment

    Time frame: At 4-month post-randomization

  9. 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

  10. 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

  11. Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews

    Time frame: At 4-mont post-randomization

  12. 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

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2016
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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