Testing myWHI: Online Self-guided Programs for Migraine

IWK Health Centre

Status: Completed

Conditions: Migraine Headache

Treatments: Behavioral: PRISM; Behavioral: SPHERE

Study type: Interventional

Funder types: Other

Identifiers

NCT02710942

PSO-EST-2014-9575

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 14 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

SPHERE intervention

Experimental group

Description:

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.

Treatment:

Behavioral: SPHERE

PRISM intervention

Experimental group

Description:

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.

Treatment:

Behavioral: PRISM

Usual care

No Intervention group

Description:

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