Mood Tracker Smartphone App for Management of Emotional Distress After TBI

Status unconfirmed · Phase 2

Conditions studied: Emotional Distress

In brief

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.

Key facts

Study ID

NCT04410770

Run by

Memorial Hermann Health System

People needed

126

Starts

2019-04-23

Expected to finish

2022-09-29

Last updated by the study team

2020-09-02

Who can join

Age: 18 and older, up to 62. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medically documented complicated mild, moderate, or severe TBI
• Previous assent to be contacted regarding TBI related studies
• One year or greater post-injury
• Age 18 to 62 years at time of screening
• Adequately fluent in English to complete an interview and all study measures
• Living in a residential setting in the community
• Has capacity to give consent to medical research
• Access to a smartphone with capacity to download and run the T2 Mood Tracker app
• Acknowledges some degree of emotional distress

You may not qualify if…

• Has capacity to give consent to medical research
• Access to a smartphone with capacity to download and run the T2 Mood Tracker app
• Acknowledges some degree of emotional distress

Where it is running

• Memorial Hermann Hospital-Texas Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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