An Intervention to Improve Adolescent Headache Self-management

NCT ID: NCT02475005

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-20
• Study Completion Date: 2017-11-28

Brief Summary

The purpose of this study is to test the efficacy of a new app to help adolescents with chronic or reoccurring headaches self manage pain.

Detailed Description

Headaches dramatically affect adolescents' overall functioning and quality of life. We have developed a highly engaging mobile-based program that will help adolescents to make connections between behaviors and symptoms, and to ultimately improve functioning and quality of life. The mobile-based program will provide a state of the art pain tracker, a variety of coping strategies, and information about self-management of symptoms. This app will offer a maximally engaging way to help adolescents track their pain, make connections between lifestyle and pain, and learn key self-management skills.

The study involves the participant being randomized into either the experimental group, where he/she will be using this mobile application to track their headache symptoms, or the control group, where he/she will receive headache treatment as usual; the control group will not be using an app for this study. The intervention will last for two months.

Participants will be assessed at baseline, at 2-months post baseline, at 3-months post baseline, and at 6-months post baseline. All participants will be asked to complete online questionnaires about their headaches. We plan to enroll 144 adolescent participants with headaches, as well as one caregiver (meaning a parent/guardian) for each adolescent.

Conditions

Pain; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mobile self management app on smartphone

Mobile self management app on smartphone

Group Type: EXPERIMENTAL

pain self management app on smartphone

Intervention Type: BEHAVIORAL

Treatment as usual

Treatment as usual (control group)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pain self management app on smartphone

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between ages 13 and 17 (inclusive)
• Able to read and speak English
• Has recurring headaches that are not related to another medical condition
• iPhone user with access to an iPhone [4/4S or later] for use during the intervention period

Parent or guardian of an adolescent who meets the above eligibility criteria for adolescent participants

Exclusion Criteria

• Secondary headache or seizure disorder. Examples include: increased intracranial pressure, hydrocephalus, traumatic brain injury, benign or cancerous brain
• Cognitive impairment or psychiatric condition that would interfere with ability to use the mobile application or complete the assessments

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stephen F Butler, PhD

INDUSTRY

Sponsor Role: lead

Responsible Party

Stephen F Butler, PhD

Senior VP/Chief Science Officer

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Inflexxion

Newton, Massachusetts, United States

Countries

United States

Other Identifiers

2R44HD066920-03A1

Identifier Type: NIH

Identifier Source: org_study_id

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