Testing myWHI: Online Self-guided Programs for Migraine

Migraine Headache Clinical Trial

Official title:

Testing the Feasibility of Two Self-guided Web-based Interventions for Adolescents and Young Adults With Migraine: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710942
• Other study ID #: PSO-EST-2014-9575
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2018
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Behavioral:
• SPHERE

• PRISM

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Proportion of randomized participants who drop out		At 4-month post-randomization
Primary	Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically		At 4-month post-randomization
Primary	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
Primary	Proportion of randomized participants who complete the 4-month post-randomization assessment		At 4-month post-randomization
Primary	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
Primary	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
Primary	Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews		At 4-mont post-randomization
Primary	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

External Links

•   Link