Engagement, Acceptability, and Effectiveness of the Self-Care and Coach-Supported Versions of the Vira Digital Behavior Change Platform Among Young Adults at Risk for Depression and Obesity: Pilot Randomized Controlled Trial.

Adolescence and early adulthood are pivotal stages for the onset of mental health disorders and the development of health behaviors. Digital behavioral activation interventions, with or without coaching support, hold promise for addressing risk factors for both mental and physical health problems by offering scalable approaches to expand access to evidence-based mental health support. This 2-arm pilot randomized controlled trial evaluated 2 versions of a digital behavioral health product, Vira (Ksana Health Inc), for their feasibility, acceptability, and preliminary effectiveness in improving mental health in young adults with depressive symptoms and obesity risk factors. A total of 73 participants recruited throughout the United States were randomly assigned to use Vira either as a self-guided product (Vira Self-Care) or with support from a health coach (Vira+Coaching) for 12 weeks. The Vira smartphone app used passive sensing of behavioral data related to mental health and obesity risk factors (ie, activity, sleep, mobility, and language patterns) and offered users personalized insights into patterns of behavior associated with their daily mood. Participants completed self-reported outcome measures at baseline and follow-up (12 weeks). All study procedures were completed via digital communications. Both versions of Vira showed strong user engagement, acceptability, and evidence of effectiveness in improving mental health and stress. However, users receiving coaching exhibited more sustained engagement with the platform and reported greater reductions in depression (Cohen d=0.45, 95% CI 0.10-0.82) and anxiety (Cohen d=0.50, 95% CI 0.13-0.86) compared to self-care users. Both interventions also resulted in reduced stress (Vira+Coaching: Cohen d=-1.05, 95% CI -1.57 to --0.50; Vira Self-Care: Cohen d=-0.78, 95% CI -1.33 to -0.23) and were perceived as useful and easy to use. Coached users also reported reductions in sleep-related impairment (Cohen d=-0.51, 95% CI -1.00 to -0.01). Moreover, participants increased their motivation for and confidence in making behavioral changes, with greater improvements in confidence among coached users. An app-based intervention using passive mobile sensing to track behavior and deliver personalized insights into behavior-mood associations demonstrated feasibility, acceptability, and preliminary effectiveness for reducing depressive symptoms and other mental health problems in young adults. Future directions include (1) optimizing the interventions, (2) conducting a fully powered trial that includes an active control condition, and (3) testing mediators and moderators of outcome effects. ClinicalTrials.gov NCT05638516; https://clinicaltrials.gov/study/NCT05638516.

Weiner LS ，Crowley RN ，Sheeber LB ，Koegler FH ，Davis JF ，Wells M ，Funkhouser CJ ，Auerbach RP ，Allen NB ... -  《JMIR Mental Health》

Erratum: Eyestalk Ablation to Increase Ovarian Maturation in Mud Crabs.

《Jove-Journal of Visualized Experiments》

Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity.

Obesity is considered to be a risk factor for various diseases, and its incidence has tripled worldwide since 1975. In addition to potentially being at risk for adverse health outcomes, people with overweight or obesity are often stigmatised. Behaviour change interventions are increasingly delivered as mobile health (m-health) interventions, using smartphone apps and wearables. They are believed to support healthy behaviours at the individual level in a low-threshold manner. To assess the effects of integrated smartphone applications for adolescents and adults with overweight or obesity. We searched CENTRAL, MEDLINE, PsycINFO, CINAHL, and LILACS, as well as the trials registers ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform on 2 October 2023 (date of last search for all databases). We placed no restrictions on the language of publication. Participants were adolescents and adults with overweight or obesity. Eligible interventions were integrated smartphone apps using at least two behaviour change techniques. The intervention could target physical activity, cardiorespiratory fitness, weight loss, healthy diet, or self-efficacy. Comparators included no or minimal intervention (NMI), a different smartphone app, personal coaching, or usual care. Eligible studies were randomised controlled trials of any duration with a follow-up of at least three months. We used standard Cochrane methodology and the RoB 2 tool. Important outcomes were physical activity, body mass index (BMI) and weight, health-related quality of life, self-efficacy, well-being, change in dietary behaviour, and adverse events. We focused on presenting studies with medium- (6 to < 12 months) and long-term (≥ 12 months) outcomes in our summary of findings table, following recommendations in the core outcome set for behavioural weight management interventions. We included 18 studies with 2703 participants. Interventions lasted from 2 to 24 months. The mean BMI in adults ranged from 27 to 50, and the median BMI z-score in adolescents ranged from 2.2 to 2.5. Smartphone app versus no or minimal intervention Thirteen studies compared a smartphone app versus NMI in adults; no studies were available for adolescents. The comparator comprised minimal health advice, handouts, food diaries, smartphone apps unrelated to weight loss, and waiting list. Measures of physical activity: at 12 months' follow-up, a smartphone app compared to NMI probably reduces moderate to vigorous physical activity (MVPA) slightly (mean difference (MD) -28.9 min/week (95% confidence interval (CI) -85.9 to 28; 1 study, 650 participants; moderate-certainty evidence)). We are very uncertain about the results of estimated energy expenditure and cardiorespiratory fitness at eight months' follow-up. A smartphone app compared with NMI probably results in little to no difference in changes in total activity time at 12 months' follow-up and leisure time physical activity at 24 months' follow-up. Anthropometric measures: a smartphone app compared with NMI may reduce BMI (MD of BMI change -2.6 kg/m2, 95% CI -6 to 0.8; 2 studies, 146 participants; very low-certainty evidence) at six to eight months' follow-up, but the evidence is very uncertain. At 12 months' follow-up, a smartphone app probably resulted in little to no difference in BMI change (MD -0.1 kg/m2, 95% CI -0.4 to 0.3; 1 study; 650 participants; moderate-certainty evidence). A smartphone app compared with NMI may result in little to no difference in body weight change (MD -2.5 kg, 95% CI -6.8 to 1.7; 3 studies, 1044 participants; low-certainty evidence) at 12 months' follow-up. At 24 months' follow-up, a smartphone app probably resulted in little to no difference in body weight change (MD 0.7 kg, 95% CI -1.2 to 2.6; 1 study, 245 participants; moderate-certainty evidence). A smartphone app compared with NMI may result in little to no difference in self-efficacy for a physical activity score at eight months' follow-up, but the results are very uncertain. A smartphone app probably results in little to no difference in quality of life and well-being at 12 months (moderate-certainty evidence) and in little to no difference in various measures used to inform dietary behaviour at 12 and 24 months' follow-up. We are very uncertain about adverse events, which were only reported narratively in two studies (very low-certainty evidence). Smartphone app versus another smartphone app Two studies compared different versions of the same app in adults, showing no or minimal differences in outcomes. One study in adults compared two different apps (calorie counting versus ketogenic diet) and suggested a slight reduction in body weight at six months in favour of the ketogenic diet app. No studies were available for adolescents. Smartphone app versus personal coaching Only one study compared a smartphone app with personal coaching in adults, presenting data at three months. Two studies compared these interventions in adolescents. A smartphone app resulted in little to no difference in BMI z-score compared to personal coaching at six months' follow-up (MD 0, 95% CI -0.2 to 0.2; 1 study; 107 participants). Smartphone app versus usual care Only one study compared an app with usual care in adults but only reported data at three months on participant satisfaction. No studies were available for adolescents. We identified 34 ongoing studies. The available evidence is limited and does not demonstrate a clear benefit of smartphone applications as interventions for adolescents or adults with overweight or obesity. While the number of studies is growing, the evidence remains incomplete due to the high variability of the apps' features, content and components, which complicates direct comparisons and assessment of their effectiveness. Comparisons with either no or minimal intervention or personal coaching show minor effects, which are mostly not clinically significant. Minimal data for adolescents also warrants further research. Evidence is also scarce for low- and middle-income countries as well as for people with different socio-economic and cultural backgrounds. The 34 ongoing studies suggest sustained interest in the topic, with new evidence expected to emerge within the next two years. In practice, clinicians and healthcare practitioners should carefully consider the potential benefits, limitations, and evolving research when recommending smartphone apps to adolescents and adults with overweight or obesity.

Metzendorf MI ，Wieland LS ，Richter B 《Cochrane Database of Systematic Reviews》

A personal sensing technology enabled service versus a digital psychoeducation control for primary care patients with depression and anxiety: a pilot randomized controlled trial.

Technology-enabled services (TES; clinical services that include both technology-driven [e.g., personal sensing technologies] and person-powered support elements) may address gaps in depression and anxiety treatments in healthcare settings. The current study: (1) developed a TES tailored for Primary Care patients with depression and/or anxiety, and (2) conducted a pilot randomized controlled trial to assess the efficacy of the TES compared to a digital psychoeducation control app. Participants were randomized to either: (1) TES: the "Vira" smartphone app (Ksana Health Inc.), informed by behavioral activation and using passive sensing technology to provide behavioral "insights" and target behaviors associated with mental health symptoms, alongside lay-provider coaching, or (2) Control: the Mood Education mobile app (ME), containing static psychoeducational resources designed to target mental health symptoms. Both apps collected usage data. Participants completed assessments on depression (PHQ-9), anxiety (GAD-7), health-related quality of life (PedsQL), and engagement (TWEETs) at baseline, mid-treatment (week 4), end-of-treatment (week 8), and post-treatment (week 12). Participants (N = 130) were randomized to receive either the TES (Vira; Mage= 30) or ME (Mage= 33). Linear mixed-effects models determined significant improvements in PHQ-9 and GAD-7 scores for participants across both conditions (ps < 0.001). There was no interactive effect of intervention and time for the PHQ-9 (p = .90) nor the GAD-7 (p = .49). Adjusting for baseline differences and randomization strata, TES participants reported a greater change in a quality of life rating of Physical Functioning (PedsQL) across time (p = .018). TES participants also reported higher levels of engagement and demonstrated higher app usage. However, adjusting for baseline symptom severity, neither app usage nor coach interaction frequency moderated outcomes (ps ≥ 0.2). While the TES demonstrated superior engagement, improvements in depressive and anxious symptoms for both conditions speak to the potential benefit of both TES and low-intensity psychoeducation treatments in care settings. Future research is needed to better understand which patients might differentially benefit from TESs and broader personal sensing technologies over low-intensity treatments. ClinicalTrials.gov NCT05406791.

Stiles-Shields C ，Reyes KM ，Lakhtakia T ，Smith SR ，Barnas OE ，Gray EL ，Krause CJ ，Kruzan KP ，Kwasny MJ ，Mir Z ，Panjwani S ，Rothschild SK ，Sánchez-Johnsen L ，Winquist NW ，Lattie EG ，Allen NB ，Reddy M ，Mohr DC ... -  《BMC Psychiatry》

Mobile apps to reduce depressive symptoms and alcohol use in youth: A systematic review and meta-analysis: A systematic review.

Among youth, symptoms of depression, anxiety, and alcohol use are associated with considerable illness and disability. Youth face many personal and health system barriers in accessing mental health care. Mobile applications (apps) offer youth potentially accessible, scalable, and anonymous therapy and other support. Recent systematic reviews on apps to reduce mental health symptoms among youth have reported uncertain effectiveness, but analyses based on the type of app-delivered therapy are limited. We conducted this systematic review with youth co-researchers to ensure that this review addressed the questions that were most important to them. The objective of this review is to synthesize the best available evidence on the effectiveness of mobile apps for the reduction of depressive symptoms (depression, generalized anxiety, psychological distress) and alcohol use among youth. We conducted electronic searches of the following bibliographic databases for studies published between January 1, 2008, and July 1, 2022: MEDLINE (via Ovid), Embase (via Ovid), PsycINFO (via Ovid), CINAHL (via EBSCOHost), and CENTRAL (via the Cochrane Library). The search used a combination of indexed terms, free text words, and MeSH headings. We manually screened the references of relevant systematic reviews and included randomized controlled trials (RCTs) for additional eligible studies, and contacted authors for full reports of identified trial registries or protocols. We included RCTs conducted among youth aged 15-24 years from any setting. We did not exclude populations on the basis of gender, socioeconomic status, geographic location or other personal characteristics. We included studies which assessed the effectiveness of app-delivered mental health support or therapy interventions that targeted the management of depressive disorders and/or alcohol use disorders. We excluded apps that targeted general wellness, apps which focused on prevention of psychological disorders and apps that targeted bipolar disorder, psychosis, post-traumatic stress disorder, attention-deficit hyperactivity disorder, substance use disorders (aside from alcohol), and sleep disorders. Eligible comparisons included usual care, no intervention, wait-list control, alternative or controlled mobile applications. We included studies which reported outcomes on depressive symptoms, anxiety symptoms, alcohol use and psychological distress over any follow-up period. We standardized the PICO definitions (population, intervention, comparison, and outcome) of each included study and grouped studies by the type of therapy or support offered by the app. Whenever app design and clinical homogeneity allowed, we meta-analyzed outcomes using a random-effects model. Outcome data measured using categorical scales were synthesized using odds ratios. Outcome data measured using continuous scales were synthesized as the standardized mean difference. We assessed the methodological quality of each included study using the Cochrane Risk of Bias 2.0 tool and we assessed certainty of the evidence using the GRADE approach. From 5280 unique citations, we included 36 RCTs published in 37 reports and conducted in 15 different countries (7984 participants). Among the 36 included trials, we assessed two with an overall low risk of bias, 8 trials with some concern regarding risk of bias, and 26 trials with a high risk of bias. Interventions varied in the type of therapy or supports offered. The most common intervention designs employed mindfulness training, cognitive behavioral therapy (CBT), or a combination of the two (mindfulness + CBT). However, other interventions also included self-monitoring, medication reminders, cognitive bias modification or positive stimulation, dialectical behavioral therapy, gamified health promotion, or social skill building. Mindfulness apps led to short term improvements in depressive symptoms when compared to a withheld control (SMD = -0.36; 95% CI [-0.63, -0.10]; p = 0.007, n = 3 RCTs, GRADE: very low certainty) and when compared to an active control (SMD = -0.27; 95% CI [-0.53, -0.01]; p = 0.04, n = 2 RCTs, GRADE: very low). Apps delivering this type of support also significantly improved symptoms of anxiety when compared to a withheld control (SMD = -0.35; 95% CI [-0.60, -0.09]; p = 0.008, n = 3 RCTs, GRADE: very low) but not when compared to an active control (SMD = -0.24; 95% CI [-0.50, 0.02]; p = 0.07, n = 2 RCTs, GRADE: very low). Mindfulness apps showed improvements in psychological stress that approached statistical significance among participants receiving the mindfulness mobile apps compared to those in the withheld control (SMD = -0.27; 95% CI [-0.56, 0.03]; p = .07, n = 4 RCTs, GRADE: very low). CBT apps also led to short-term improvements in depressive symptoms when compared to a withheld control (SMD = -0.40; 95% CI [-0.80, 0.01]; p = 0.05, n = 2 RCTs, GRADE: very low) and when compared to an active control (SMD = -0.59; 95% CI [-0.98, -0.19]; p = 0.003, n = 2 RCTs, GRADE: very low). CBT-based apps also improved symptoms of anxiety compared to a withheld control (SMD = -0.51; 95% CI [-0.94, -0.09]; p = 0.02, n = 3 RCTs, GRADE: very low) but not when compared to an active control (SMD = -0.26; 95% CI [-1.11, 0.59]; p = 0.55, n = 3 RCTs, GRADE: very low). Apps which combined mindfulness and CBT did not significantly improve symptoms of depression (SMD = -0.20; 95% CI [-0.42, 0.02]; p = 0.07, n = 2 RCTs, GRADE: very low) or anxiety (SMD = -0.21; 95% CI [-0.49, 0.07]; p = 0.14, n = 2 RCTs, GRADE: very low). However, these apps did improve psychological distress (SMD = -0.43; 95% CI [-0.74, -0.12]; p = 0.006, n = 2 RCTs, GRADE: very low). The results of trials on apps to reduce alcohol use were inconsistent. We did not identify any harms associated with the use of apps to manage mental health concerns. All effectiveness results had a very low certainty of evidence rating using the GRADE approach, meaning that apps which deliver therapy or other mental health support may reduce symptoms of depression, anxiety and psychological distress but the evidence is very uncertain. We reviewed evidence from 36 trials conducted among youth. According to our meta-analyses, the evidence is very uncertain about the effect of apps on depression, anxiety, psychological distress, and alcohol use. Very few effects were interpreted to be of clinical importance. Most of the RCTs were small studies focusing on efficacy for youth at risk for depressive symptoms. Larger trials are needed to evaluate effectiveness and allow for further analysis of subgroup differences. Longer trials are also needed to better estimate the clinical importance of these apps over the long term.

Magwood O ，Saad A ，Ranger D ，Volpini K ，Rukikamirera F ，Haridas R ，Sayfi S ，Alexander J ，Tan Y ，Pottie K ... -  《-》