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Mood Tracker Smartphone App for Management of Emotional Distress After TBI

NCT04410770 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2020-09-02

No results posted yet for this study

Summary

Traumatic brain injury (TBI) is a common type of injury that affects thousands of people a year. TBI can cause a number of disabilities such as impaired cognition, decreased strength, decreased balance, problems controlling feelings, and difficulty communicating with others. Other problems that persons with TBI can have in the period after hospital discharge are anxiety and depress. These problems are common. At about one year after being injured, 44% of people have anxiety and 40% have depression. By five years after injury, 28% have depression and 17% have anxiety. If we think of emotional distress as having depression, anxiety, or both, at one year, 53% of people with TBI have emotional distress and, at five years, 38% have emotional distress. Many people with TBI are reluctant to seek help for emotional problems and when they do want help, it is hard to find. Many states have a shortage of mental health providers, many injured persons lack insurance that would pay for mental health treatment, and treatment may only be available a long distance from where people live.

In an attempt to address this problem, we are conducting a study designed to determine whether a self-management strategy can improve emotional distress or make emotional distress less like to develop. Previous studies have shown that simply keeping track of a problem may improve it. For example, tracking how often one has headaches can result in fewer headaches. Keeping track of one's blood pressure can lead to lower blood pressure. We are conducting this study to see if tracking one's level of emotional distress will result in lower levels of emotional distress. We are asking people with TBI to rate their levels of emotional distress several times a week using a special smart phone app. We will then conduct statistical tests to see if completing these ratings can cause people to have less emotional distress or prevent emotional distress from developing.

Conditions

  • Emotional Distress

Interventions

BEHAVIORAL

Mood tracker ratings

The participant rates his/her emotional distress several times a week using a specially developed smart phone app. The participant receives support call to ensure that self-ratings are being completed.

Sponsors & Collaborators

  • TIRR Memorial Hermann

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Memorial Hermann Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2022-04-30
Completion
2022-09-29

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04410770 on ClinicalTrials.gov