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Background: The Feeling Good App is an automated stand-alone digital mobile mental health tool currently undergoing beta testing with the goal of providing evidence-informed self-help lessons and exercises to help individuals reduce depressive symptoms without guidance from a mental health provider. Users work through intensive basic training (IBT) and ongoing training models that provide education regarding cognitive behavioral therapy principles from a smartphone., Objective: The key objective of this study was to perform a nonsponsored third-party academic assessment of an industry-generated data set; this data set focused on the safety, feasibility, and accessibility of a commercial automated digital mobile mental health app that was developed to reduce feelings associated with depression., Methods: The Feeling Good App development team created a waitlist cohort crossover design and measured symptoms of depression and anxiety using the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and an app-specific measure of negative feelings called the 7 Dimension Emotion Slider (7-DES). The waitlist cohort crossover design divided the participants into 2 groups, where 48.6% (141/290) of the participants were given immediate access to the apps, while 51.4% (149/290) were placed on a 2-week waitlist before being given access to the app. Data collected by the Feeling Good App development team were deidentified and provided to the authors of this paper for analysis through a nonsponsored university data use agreement. All quantitative data were analyzed using SPSS Statistics (version 28.0; IBM Corp). Descriptive statistics were calculated for demographic variables. Feasibility and acceptability were descriptively assessed. All participants included in the quantitative data were given access to the Feeling Good App; this study did not include a control group., Results: In terms of safety, there was no statistically significant change in suicidality from preintervention to postintervention time points (t 288 =0.0; P>.99), and there was a statistically significant decrease in hopelessness from preintervention to postintervention time points (F 289 =30.16; P<.01). In terms of acceptability, 72.2% (166/230) of the users who started the initial 2-day IBT went on to complete it, while 34.8% (80/230) of the users who started IBT completed the entirety of the apps' 4-week protocol (150/230, 65.22% dropout rate over 4 weeks)., Conclusions: This study is the first reported proof-of-concept evaluation of the Feeling Good App in terms of safety, feasibility, and statistical trends within the data set. It demonstrates a feasible and novel approach to industry and academic collaboration in the process of developing a digital mental health technology translated from an existing evidence-informed treatment. The results support the prototype app as safe for a select nonclinical population. The app had acceptable levels of engagement and dropouts throughout the intervention. Those who stay engaged showed reductions in symptom severity of depression warranting further investigation of the app's efficacy., (©Nicholas Bisconti, Mackenzie Odier, Matthew Becker, Kim Bullock. Originally published in JMIR Mental Health (https://mental.jmir.org), 10.05.2024.)

Background: Major depressive disorder (MDD) is a global crisis with increasing incidence and prevalence. There are many established evidence-based psychotherapies (EBPs) for depression, but numerous barriers still exist; most notably, access and dissemination. Virtual reality (VR) may offer some solutions to existing constraints of EBPs for MDD. Objective: We aimed to examine the feasibility, acceptability, and tolerability of using VR as a method of delivering behavioral activation (BA) for adults diagnosed with MDD during a global pandemic and to explore for signs of clinical efficacy by comparing VR-enhanced BA (VR BA) to a standard BA treatment and a treatment as usual control group for individuals diagnosed with MDD. Methods: A feasibility trial using a 3-armed, unblinded, randomized controlled pilot design was conducted. The study took place remotely via Zoom telehealth visits between April 8, 2020, and January 15, 2021. This study used a 3-week, 4-session protocol in which VR BA participants used a VR headset to complete their BA homework. Feasibility was measured using dropout rates, serious adverse events, completion of homework, an adapted telepresence scale, the Simulator Sickness Questionnaire, the Brief Agitation Measure, and an adapted Technology Acceptance Model. Efficacy was assessed using the Patient Health Questionnaire-9. Results: Of the 35 participants assessed for eligibility, 13 (37%) were randomized into VR BA (n=5, 38%), traditional BA (n=4, 31%), or a treatment as usual control (n=4, 31%). The mean age of the 13 participants (5/13, 38% male; 7/13, 54% female; and 1/13, 8% nonbinary or third gender) was 35.4 (SD 12.3) years. This study demonstrated VR BA feasibility in participants with MDD through documented high levels of acceptability and tolerability while engaging in VR-induced pleasurable activities in conjunction with a brief BA protocol. No adverse events were reported. This study also illustrated that VR BA may have potential clinical utility for treating MDD, as the average VR BA participant's clinical severity decreased by 5.67 points, signifying a clinically meaningful change in severity from a moderate to a mild level of depression as per the Patient Health Questionnaire-9 score. Conclusions: The findings of this study demonstrate that VR BA is safe and feasible to explore for the treatment of MDD. This study documented evidence that VR BA may be efficacious and justifies further examination in an adequately powered randomized controlled trial. This pilot study highlights the potential utility that VR technology may offer patients with MDD, especially those who have difficulty accessing real-world pleasant activities. In addition, for those having difficulty accessing care, VR BA could be adapted as a first step to help people improve their mood and increase their motivation while waiting to connect with a health care professional for other EBPs. [ABSTRACT FROM AUTHOR]