Back to results

Testing myWHI: Online Self-guided Programs for Migraine

Primary Purpose

Migraine Headache

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

SPHERE

PRISM

About this trial

This is an interventional treatment trial for Migraine Headache

Eligibility Criteria

14 Years - 35 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

SPHERE intervention

PRISM intervention

Usual care

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Proportion of randomized participants who drop out

Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically

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.

Proportion of randomized participants who complete the 4-month post-randomization assessment

Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the 8-item Client Satisfaction Questionnaire (CSQ-8)

Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the single-item Patients' Global Impression of Change Scale (PGIC)

Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02710942

First Posted

November 12, 2015

Last Updated

October 15, 2018

Sponsor

IWK Health Centre

1. Study Identification

Unique Protocol Identification Number

NCT02710942

Brief Title

Testing myWHI: Online Self-guided Programs for Migraine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IWK Health Centre

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SPHERE intervention

Arm Type

Experimental

Arm Description

Arm Title

PRISM intervention

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

SPHERE

Intervention Type

Behavioral

Intervention Name(s)

PRISM

Primary Outcome Measure Information:

Title

Average number of individuals who complete the online screening per month

Description

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.

Time Frame

After reaching our desired sample size for randomization

Title

Proportion of recruited participants who are eligible for study entry

Description

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.

Time Frame

After reaching our desired sample size for randomization

Title

Proportion of eligible participants who consent

Description

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.

Time Frame

After reaching our desired sample size for randomization

Title

Proportion of consented participants who are randomized

Description

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.

Time Frame

After reaching our desired sample size for randomization

Title

Proportion of randomized participants who drop out

Time Frame

At 4-month post-randomization

Title

Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically

Time Frame

At 4-month post-randomization

Title

Proportion of consented participants who complete the baseline assessment

Description

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.

Time Frame

After reaching our desired sample size for randomization

Title

Proportion of randomized participants who complete the 4-month post-randomization assessment

Time Frame

At 4-month post-randomization

Title

Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the 8-item Client Satisfaction Questionnaire (CSQ-8)

Time Frame

At 4-mont post-randomization

Title

Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the single-item Patients' Global Impression of Change Scale (PGIC)

Time Frame

At 4-mont post-randomization

Title

Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews

Time Frame

At 4-mont post-randomization

Title

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

Time Frame

At 4-mont post-randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Huguet, PhD

Organizational Affiliation

IWK Health Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

IWK Health Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://mywhi.ca/info/

Description

Related Info

Learn more about this trial

Testing myWHI: Online Self-guided Programs for Migraine

We'll reach out to this number within 24 hrs