NCT04410770

Mood Tracker Smartphone App for Management of Emotional Distress After TBI

Status unknown Phase 2 Last updated 2 September 2020

What this trial tests

Phase 2 trial testing Mood tracker ratings in Emotional Distress in 126 participants. Status unknown.

Timeline

23 April 2019

Primary endpoint
30 April 2022

29 September 2022

Quick facts

Lead sponsor	Memorial Hermann Health System
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	126
Start date	23 April 2019
Primary completion	30 April 2022
Estimated completion	29 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Mood tracker ratings

Conditions studied

• Emotional Distress — all drugs for Emotional Distress →

Sponsor

Memorial Hermann Health System

Who can join

Adults 18 to 62, any sex, with Emotional Distress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dimensions of participation as predictors of satisfaction with roles and abilities after traumatic brain injury.
   Wisinger AM, Juengst SB, Sander AM, Broomfield RR, et al · · 2026 · PMID 40608439 · DOI 10.1037/rep0000627