Testing myWHI: Online Self-guided Programs for Migraine

NCT ID: NCT02710942

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

SPHERE

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

PRISM

Intervention Type BEHAVIORAL

Usual care

Participants can continue doing what they usually do to deal with their migraines.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SPHERE

Intervention Type BEHAVIORAL

PRISM

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IWK Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Anna Huguet

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Huguet, PhD

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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PSO-EST-2014-9575

Identifier Type: -

Identifier Source: org_study_id

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