Mood Tracker Smartphone App for Management of Emotional Distress After TBI

NCT04410770 | Unknown Phase 2

• 1 other identifier: 90DPTB0016
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Traumatic Brain Injury, Self-management, depression, anxiety, smart phone app

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Active intervention

ACTIVE COMPARATOR

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.

Behavioral: Mood tracker ratings

Wait list

NO INTERVENTION

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.

Interventions

Mood tracker ratings BEHAVIORAL

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.

Active intervention

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Memorial Hermann Health System: lead
• TIRR Memorial Hermann: collaborator
• Baylor College of Medicine: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Memorial Hermann Hospital-Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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. 2025 Jul 3. doi: 10.1037/rep0000627. Online ahead of print.

  PMID: 40608439 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinical coordinator screens, consents, and completes baseline assessments with the participants. The clinical coordinator passes on the participants to the counselor who completes the support calls. The clinical coordinator and the counselor are unmasked. The participant is unmasked as he/she is aware of when he/she is receiving the support calls and when he/she is not. The 6 and 12 week outcomes are collected by a separate research assistant who is masked. The investigators are not exposed to the randomization process and are unaware of which arm the participant is assigned to.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel group, single masked, controlled trial with cross-over

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: April 23, 2019
• Primary Completion: April 30, 2022
• Study Completion: September 29, 2022
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of all planned papers or 5 years after all data have been collected.
• Access Criteria: Direct request to one of the investigator by an investigator with a specific clinical question who has the capability to carry a successful new analysis of the study data.

Locations

US (1)