2. Materials and Methods
The study protocol was approved for use of human subjects by the Shepherd Center Institutional Review Board. Clinicians were directly involved in the study design, administration, and data collection. Participants, intervention providers, and those assessing the outcomes were not blinded.Feasibility studies are usually conducted in preparation for a larger, main study [This feasibility study focuses on three core aims. The first aim, evaluating preliminary efficacy of the intervention, was addressed by measuring participant goal attainment, change in clinical measures of executive function, and change in self-assessment of knowledge of how to use the intervention. The outcomes of participants who received the SwapMyMood app were compared to outcomes of those who only received conventional care. The second aim, measuring acceptability of the SwapMyMood app by target users, was measured by using a standardized usability scale and gathering feedback from participants regarding their experience using the app. The third aim, assessing the study design for implementation in a target clinical setting, was achieved by evaluating the quality and completeness of data collected as well as the ease/difficulty of recruiting and retaining participants within the context of an outpatient program serving SM/Vs with mTBI and co-occurring psychological conditions.