An Intervention to Improve Adolescent Headache Self-management (TH)

Stephen F Butler, PhD

Status

Completed

Conditions

Pain

Headache

Treatments

Behavioral: pain self management app on smartphone

Study type

Interventional

Funder types

Industry

Identifiers

NCT02475005

2R44HD066920-03A1

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,200 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

[The above age limits are specific to adolescent participants.]

Inclusion Criteria - Adolescents

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

Exclusion Criteria - Adolescents

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

Inclusion Criteria - Caregivers

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