Testing myWHI: Online Self-guided Programs for Migraine

Not Applicable

Completed

• Conditions: Migraine Headache

• Registration Number: NCT02710942
• Lead Sponsor: IWK Health Centre

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-12
• Study Start: 2016-02
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-17
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of consented participants who are randomized	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 complete the baseline assessment	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.
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the single-item Patients' Global Impression of Change Scale (PGIC)	At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the 8-item Client Satisfaction Questionnaire (CSQ-8)	At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews	At 4-mont post-randomization
Proportion of eligible participants who consent	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.
Average number of individuals who complete the online screening per month	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	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.
Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically	At 4-month post-randomization
Proportion of randomized participants who complete the 4-month post-randomization assessment	At 4-month 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	At 4-mont post-randomization
Proportion of randomized participants who drop out	At 4-month post-randomization

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada