Loading search results
Use of a Mood Tracker Smartphone App as a Chronic Health Management Intervention for Emotional Distress in Persons With TBI
Sponsor study identifier
interventional
126
1 country
1
Study Start
April 23, 2019
Actual (reported)Primary Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 29, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 29, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 23, 2019
Actual (reported)May 27, 2020
Actual (reported)June 1, 2020
Actual (reported)April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 29, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Personal Health Questionnaire - 9 (PHQ-9) and Global Anxiety Disorder - 7 (GAD-7) scores combined.
Scores for the PHQ-9 range from 0 to 27 with higher scores indicating greater depression. Scores for the GAD-7 range from 0 to 21 with higher scores indicating greater anxiety. These are measures of depression and anxiety that were developed for public health research. Scores from the 2 measures are combined to form an index of emotional distress.
6 weeks from baseline.
Participants assigned to the active treatment arm are trained to use the mood tracker app and instructed to complete multiple self-ratings each week. Each the participant receives a support call each week for 6 weeks to engage the participant in the study and to address any problems the participant may have in completing self ratings. After 6 weeks of self-ratings, the participant complete the 6 week outcome. The participant is encouraged to continue completing the self-ratings, but does not receive any more support calls. After 6 more weeks, the 12 week outcome is assessed the participant's involvement with the study ends.
Wait list participants have no study activities for 6 weeks after completing the baseline assessment. After 6 weeks, list participants complete the 6 week assessment. After completing the assessment. wait list participants are trained to use the mood tracker app and instructed to complete multiple self-ratings each week. Each the participant receives a support call each week for 6 weeks to engage the participant in the study and to address any problems the participant may have in completing self ratings. After 6 weeks of self-ratings, the participant complete the 12 week outcome and the participant's involvement with the study ends.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Hermann Hospital-Texas Medical Center
Houston, Texas, 77030, United States
Wisinger AM, Juengst SB, Sander AM, Broomfield RR, Vos L, Williams MW, Sherer M. Dimensions of participation as predictors of satisfaction with roles and abilities after traumatic brain injury. Rehabil Psychol. 2026 May;71(2):191-197. doi: 10.1037/rep0000627. Epub 2025 Jul 3.
First Submitted
May 27, 2020
First Posted
June 1, 2020
Contact the study team to confirm eligibility.
Study Start
April 23, 2019
Actual (reported)Primary Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 29, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 2, 2020
Record last verified: 2020-08
Data will be made available upon direct request to one of the investigators after all planned papers are published or after 5 years after completion of data collection which ever comes first.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: