Lead Center:Texas TBI Model System of TIRR
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This is a randomized controlled trial of the effectiveness of a mobile app mood self-monitoring intervention augmented by brief supportive telephone calls to decrease emotional distress in persons with complicated mild to severe TBI at least one year post-injury. The active treatment group will be compared to a wait-list control group, which will also be offered the intervention after their follow-up for the control condition. We will also investigate factors that determine the magnitude of the treatment effect, including the number of days the mobile app was used and the number of time per day that ratings were made. We will also track the use of the mobile app for six weeks following the end of the intervention period and will assess maintenance of improvements in emotional distress over that period. Our primary outcome will be an index of emotional distress created by combining scores from the PHQ-9 and GAD-7. Secondary outcomes include Satisfaction With Life Scale, PART-O, and four factors from the TBI-QOL (Negative Emotion, Positive Emotion, Sense of Self, and Participation).