Testing myWHI: Online Self-guided Programs for Migraine

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: Completed
• Conditions: Migraine Headache
• Intervention / Treatment: Behavioral: SPHERE; Behavioral: PRISM

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Average number of individuals who complete the online screening per month	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	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	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	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		At 4-month post-randomization
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 consented participants who complete the baseline assessment	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		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)		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)		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 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

Collaborators and Investigators

• Sponsor: IWK Health Centre

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (ESTIMATE): March 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: PSO-EST-2014-9575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO