Clinical trial NCT02710942: Testing myWHI: Online Self-guided Programs for Migraine
Official title: Testing the Feasibility of Two Self-guided Web-based Interventions for Adolescents and Young Adults With Migraine: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Headache
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Average number of individuals who complete the online screening per month
timeFrame: After reaching our desired sample size for randomization
measure: Proportion of recruited participants who are eligible for study entry
timeFrame: After reaching our desired sample size for randomization
measure: Proportion of eligible participants who consent
timeFrame: After reaching our desired sample size for randomization
measure: Proportion of consented participants who are randomized
timeFrame: After reaching our desired sample size for randomization
measure: Proportion of randomized participants who drop out
timeFrame: At 4-month post-randomization
measure: Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically
timeFrame: At 4-month post-randomization
measure: Proportion of consented participants who complete the baseline assessment
timeFrame: After reaching our desired sample size for randomization
measure: Proportion of randomized participants who complete the 4-month post-randomization assessment
timeFrame: At 4-month post-randomization
measure: Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the 8-item Client Satisfaction Questionnaire (CSQ-8)
timeFrame: At 4-mont post-randomization
measure: Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the single-item Patients' Global Impression of Change Scale (PGIC)
timeFrame: At 4-mont post-randomization
measure: Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews
timeFrame: At 4-mont post-randomization
measure: 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
timeFrame: At 4-mont post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Anna Huguet, PhD
role: PRINCIPAL_INVESTIGATOR
References: