Testing myWHI: Online Self-guided Programs for Migraine

NCT02710942 | Completed

• 1 other identifier: PSO-EST-2014-9575
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (3)

SPHERE intervention

EXPERIMENTAL

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

PRISM intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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

Interventions

SPHERE BEHAVIORAL

SPHERE intervention

PRISM BEHAVIORAL

PRISM intervention

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anna Huguet, PhD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: March 17, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)