Expired Study
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Newton, Massachusetts 02464


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02475005


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Newton, Massachusetts 02464
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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