Recruiting Older Adults With Cognitive Impairments for a Smartphone Intervention During COVID-19

The Coronavirus disease 2019 (COVID-19) pandemic has introduced numerous challenges to the global scientific community and has been particularly disruptive to the conduct of ongoing clinical trials. Gerontological studies that focus on older adults with cognitive impairments have endured additional challenges ranging from increased vulnerability of this group to COVID-19, thereby prohibiting study participation, to difficulties in participant engagement as a product of a worsening Digital Divide. The purpose of this talk is to describe the pandemic-related factors that have influenced recruitment and enrollment of older adults with mild cognitive impairment and mild dementia in an ongoing feasibility study of a physical activity smartphone app. We discuss the changes we made to recruitment procedures and the impact those changes have had on the success of enrolling individuals in the study. We conclude with a discussion of feasible strategies and procedural alterations moving forward that may facilitate achievement of enrollment goals.

A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE

Background People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. Objective The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. Methods Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. Results Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F1,313=13.38; P<.001), GAD-7 (F1,313=5.87; P=.01), RAS (F1,313=23.42; P<.001), RSES (F1,313=19.28; P<.001), and SDS (F1,313=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. Conclusions We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. Trial Registration ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467

Mechanisms of Smartphone Apps for Cigarette Smoking Cessation: Results of a Serial Mediation Model From the iCanQuit Randomized Trial

Background Engagement with digital interventions is a well-known predictor of treatment outcomes, but this knowledge has had limited actionable value. Instead, learning why engagement with digital interventions impact treatment outcomes can lead to targeted improvements in their efficacy. Objective This study aimed to test a serial mediation model of an Acceptance and Commitment Therapy (ACT) smartphone intervention for smoking cessation. Methods In this randomized controlled trial, participants (N=2415) from 50 US states were assigned to the ACT-based smartphone intervention (iCanQuit) or comparison smartphone intervention (QuitGuide). Their engagement with the apps (primary measure: number of logins) was measured during the first 3 months, ACT processes were measured at baseline and 3 months (acceptance of internal cues to smoke, valued living), and smoking cessation was measured at 12 months with 87% follow-up retention. Results There was a significant serial mediation effect of iCanQuit on smoking cessation through multiple indicators of intervention engagement (ie, total number of logins, total number of minutes used, and total number of unique days of use) and in turn through increases in mean acceptance of internal cues to smoke from baseline to 3 months. Analyses of the acceptance subscales showed that the mediation was through acceptance of physical sensations and emotions, but not acceptance of thoughts. There was no evidence that the effect of the iCanQuit intervention was mediated through changes in valued living. Conclusions In this first study of serial mediators underlying the efficacy of smartphone apps for smoking cessation, our results suggest the effect of the iCanQuit ACT-based smartphone app on smoking cessation was mediated through multiple indicators of engagement and in turn through increases in the acceptance of physical sensations and emotions that cue smoking. Trial Registration Clinical Trials.gov NCT02724462; https://clinicaltrials.gov/ct2/show/NCT02724462

A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study

The goal of this study was to test the feasibility of time restricted eating (TRE) in adults with overweight and obesity. Participants (n = 50) logged all eating occasions (>0 kcal) for a 2-week run-in period using a smartphone application. Participants with eating duration ≥14 h enrolled in an open label, non-randomized, prospective 90-day TRE intervention, with a self-selected reduced eating window of 10 h. No dietary counseling was provided. Changes in anthropometrics, eating patterns and adherence after TRE were analyzed using t-tests or Wilcoxon Rank-Sum Test. The mean duration of the baseline eating window was 14 h 32 m ± 2 h 36 m (n = 50) with 56% of participants with duration ≥14 h. TRE participants (n = 16) successfully decreased their eating window from 16 h 04 m ± 1 h 24 m to 11 h 54 m ± 2 h 06 m (p < 0.001), and reduced the number of daily eating occasions by half (p < 0.001). Adherence to logging and to the reduced eating window was 64% ± 22% and 47% ± 19%, respectively. TRE resulted in decreases in body weight (−2.1 ± 3.0 kg, p = 0.017), waist circumference (−2.2 ± 4.6 cm, p = 0.002) and systolic blood pressure (−12 ± 11 mmHg, p = 0.002). This study demonstrates the feasibility and efficacy of TRE administered via a smartphone, in adults with overweight and obesity.

A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE (Preprint)

BACKGROUND People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. OBJECTIVE The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. METHODS Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. RESULTS Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (<i>F</i>_1,313=13.38; <i>P&lt;</i>.001), GAD-7 (<i>F</i>_1,313=5.87; <i>P</i>=.01), RAS (<i>F</i>_1,313=23.42; <i>P&lt;</i>.001), RSES (<i>F</i>_1,313=19.28; <i>P&lt;</i>.001), and SDS (<i>F</i>_1,313=10.73; <i>P</i>=.001). Large effects were observed for the BDI-II (<i>d=</i>0.58), RAS (<i>d=</i>0.61), and RSES (<i>d=</i>0.64); a moderate effect size was observed for the SDS (<i>d=</i>0.44), and a small effect size was observed for the GAD-7 (<i>d=</i>0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. CONCLUSIONS We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. CLINICALTRIAL ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467

Effects of Smartphone-Based Interventions on Physical Activity in Children and Adolescents: Systematic Review and Meta-analysis

Background About 70% of children and adolescents worldwide do not meet the recommended level of physical activity (PA), which is closely associated with physical, psychological, and cognitive well-being. Nowadays, the use of technologies to change PA is of interest due to the need for novel, more effective intervention approaches. The previous meta-analyses have examined smartphone-based interventions and their impact on PA in adults, but evidence in children and adolescents still needs further research. Objective This systematic review and meta-analysis aimed to determine the effectiveness of smartphone-based interventions for improving PA in children and adolescents. Methods Five electronic databases (PubMed, Web of Science, OVID, Scopus, and the China National Knowledge Infrastructure) were searched up to June 29, 2020. Randomized controlled trials with a control group that examine the effect of smartphone interventions on PA among children and adolescents were included. Bias risks were assessed using the Cochrane collaboration tool. Meta-analysis was performed to assess the pooled effect on PA using a random effects model. Subgroup analyses were conducted to examine the potential modifying effects of different factors (eg, types of intervention, intervention duration, age, measurement, study quality). Results A total of 9 studies were included in this review, including 4 mobile app interventions, 3 SMS text messaging interventions, and 2 app + SMS text messaging interventions. In general, the risk of bias of included studies was low. Compared with the control group, the use of smartphone intervention significantly improved PA (standardized mean difference [SMD] 0.44, 95% CI 0.11-0.77, P=.009), especially for total PA (TPA; weighted mean difference [WMD] 32.35, 95% CI 10.36-54.33, P=.004) and daily steps (WMD 1185, 95% CI 303-2068, P=.008), but not for moderate-to-vigorous PA (WMD 3.91, 95% CI –1.99 to 9.81, P=.19). High statistical heterogeneity was detected (I2=73.9%, P<.001) for PA. Meta-regression showed that duration (β=–.08, 95% CI –0.15 to –0.01, n=16) was a potential factor for high heterogeneity. The results of subgroup analyses indicated that app intervention (SMD 0.76, 95% CI 0.23-1.30, P=.005), children (SMD 0.64, 95% CI 0.10-1.18, P=.02), “≤8 weeks” (SMD 0.76, 95% CI 0.23-1.30, P=.005), objective measurement (SMD 0.50, 95% CI 0.09-0.91, P=.02), and low risk of bias (SMD 0.96, 95% CI 0.38-1.54, P=.001) can significantly improve PA. Conclusions The evidence of meta-analysis shows that smartphone-based intervention may be a promising strategy to increase TPA and steps in children and adolescents. Currently, app intervention may be a more effective strategy among smartphone intervention technologies. To extend the promise of smartphone intervention, the future needs to design comparative trials among different smartphone technologies. Trial Registration PROSPERO CRD42019148261; https://tinyurl.com/y5modsrd

Rise and Recharge: Effects on Activity Outcomes of an e-Health Smartphone Intervention to Reduce Office Workers’ Sitting Time

This feasibility study evaluated the effects of an individual-level intervention to target office workers total and prolonged sedentary behaviour during working hours, using an e-health smartphone application. A three-arm (Prompt-30 or 60 min Intervention arm and a No-Prompt Comparison arm), quasi-randomised intervention was conducted over 12 weeks. Behavioural outcomes (worktime sitting, standing, stepping, prolonged sitting, and physical activity) were monitored using accelerometers and anthropometrics measured at baseline, 6 weeks and 12 weeks. Cardiometabolic measures were taken at baseline and 12 weeks. Fifty-six office workers (64% female) completed baseline assessments. The Prompt-60 arm was associated with a reduction in occupational sitting time at 6 (−46.8 min/8 h workday [95% confidence interval = −86.4, −6.6], p < 0.05) and 12 weeks (−69.6 min/8 h workday [−111.0, −28.2], p < 0.05) relative to the No-Prompt Comparison arm. Sitting was primarily replaced with standing in both arms (p > 0.05). Both Intervention arms reduced time in prolonged sitting bouts at 12 weeks (Prompt-30: −27.0 [−99.0, 45.0]; Prompt-60: −25.8 [−98.4, 47.4] min/8 h workday; both p > 0.05). There were no changes in steps or cardiometabolic risk. Findings highlight the potential of a smartphone e-health application, suggesting 60 min prompts may present an optimal frequency to reduce total occupational sedentary behaviour.