Dataset Information

Efficacy of a Mobile App-Based Intervention for Young Adults With Anxiety Disorders: A Randomized Clinical Trial.

ABSTRACT:

Importance

Anxiety disorders are prevalent and undertreated among young adults. Digital mental health interventions for anxiety are promising but limited by a narrow range of therapeutic components and low user engagement.

Objective

To investigate the efficacy of and engagement with Maya, a scalable, self-guided, comprehensive mobile cognitive behavioral therapy (CBT) intervention with embedded engagement features, comparing the effects of 3 incentive conditions.

Design, setting, and participants

This randomized clinical trial recruited young adults aged 18 to 25 years with anxiety disorders through online advertisements and outpatient psychiatry clinics at Weill Cornell Medicine. Enrollment was between June 16, 2021, and November 11, 2022. Data analysis was performed from December 21, 2022, to June 14, 2024.

Intervention

Participants received a 6-week program of the intervention and were randomized to 1 of 3 different text message-based incentive conditions (gain-framed, loss-framed, or gain-social support).

Main outcomes and measures

The primary outcome was change in anxious symptoms from baseline to end of treatment, as measured by the Hamilton Anxiety Rating Scale (HAM-A). The Anxiety Sensitivity Index and the Leibowitz Social Anxiety Scale scores were secondary measures.

Results

The sample consisted of 59 participants (mean [SD] age, 23.1 [1.9] years; 46 [78%] female; 22 [37%] Asian, 3 [5%] Black, 5 [8%] Hispanic or Latino, 1 [2%] American Indian or Alaska Native, 25 [42%] White, and 6 [10%] >1 race; 32 [54%] college-educated and 12 [20%] graduate or professional school-educated; mean [SD] baseline HAM-A score, 15.0 [6.5]). Anxiety, measured by HAM-A, decreased across conditions from baseline to end of the intervention (mean difference, -5.64; 95% CI, -7.23 to -4.05), and symptomatic improvement was maintained at the week 12 follow-up (baseline to follow-up mean difference, -5.67; 95% CI, -7.29 to -4.04). However, there was no evidence that change in anxiety differed by incentive condition (loss-framed vs gain-social support mean difference, -1.40; 95% CI, -4.72 to 1.93; gain-framed vs gain-social support mean difference, 1.38; 95% CI, -1.19 to 3.96). Secondary anxiety measures (Anxiety Sensitivity Index and Liebowitz Social Anxiety Scale scores) showed a similar pattern of improvement, with no evidence of differences between incentive conditions. Participants completed most of the 12 sessions (mean [SD], 10.8 [2.1]; 95% CI, 10.3-11.4), and User Mobile Application Rating Scale app quality ratings exceeded the published threshold for acceptability at all study visits. There was no evidence that either session completion or app quality ratings differed by incentive condition.

Conclusions and relevance

In this randomized clinical trial of an app-based intervention for anxiety, the primary hypothesis that improvement in anxiety would be greatest in the condition using gain of points plus social incentives was not supported; however, the results suggest that a CBT application incorporating a full suite of CBT skills and embedded user engagement features was efficacious in improving symptoms in young adults with anxiety disorders. Given these findings, digital interventions represent a promising step toward wider dissemination of high-quality, evidence-based interventions.

Trial registration

ClinicalTrials.gov Identifier: NCT05130281.

SUBMITTER: Bress JN

PROVIDER: S-EPMC11337073 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy of a Mobile App-Based Intervention for Young Adults With Anxiety Disorders: A Randomized Clinical Trial.

Bress Jennifer N JN Falk Avital A Schier Maddy M MM Jaywant Abhishek A Moroney Elizabeth E Dargis Monika M Bennett Shannon M SM Scult Matthew A MA Volpp Kevin G KG Asch David A DA Balachandran Mohan M Perlis Roy H RH Lee Francis S FS Gunning Faith M FM

JAMA network open 20240801 8

<h4>Importance</h4>Anxiety disorders are prevalent and undertreated among young adults. Digital mental health interventions for anxiety are promising but limited by a narrow range of therapeutic components and low user engagement.<h4>Objective</h4>To investigate the efficacy of and engagement with Maya, a scalable, self-guided, comprehensive mobile cognitive behavioral therapy (CBT) intervention with embedded engagement features, comparing the effects of 3 incentive conditions.<h4>Design, settin ...[more]

PMID: 39163044

Similar Datasets

Project description:BackgroundDepression and anxiety symptoms are common among university students, but many do not receive treatment. This is often because of lack of availability, reluctance to seek help, and not meeting the diagnostic criteria required to access services. Internet-based interventions, including smartphone apps, can overcome these issues. However, a large number of apps are available, each with little evidence of their effectiveness.ObjectiveThis study aims to evaluate for the first time the effectiveness of a self-guided mobile app, Feel Stress Free, for the treatment of depression and anxiety symptoms in students.MethodsA web-based randomized controlled trial compared a cognitive behavioral therapy (CBT)-based mobile app Feel Stress Free with a wait-list control. University students self-identified as experiencing symptoms of anxiety or depression and were randomized to 6 weeks of intervention (n=84) or control (n=84), unblinded. The app is self-guided and incorporates behavioral relaxation activities, mood tracking and thought challenging, and minigames. Participants completed the Hospital Anxiety and Depression Scale online at baseline and every fortnight.ResultsAt week 6, the primary end point, there was evidence that the Feel Stress Free app reduced depression symptoms (mean difference -1.56; 95% CI -2.67 to -0.44; P=.006) but only very weak evidence that it reduced anxiety symptoms (mean difference -1.36; 95% CI -2.93 to 0.21; P=.09). At week 4, there was evidence to support the effectiveness of the intervention for anxiety symptoms (mean difference -1.94; 95% CI -3.11 to -0.77; P=.001) and, though weaker, depression symptoms (mean difference -1.08; 95% CI -2.12 to -0.04; P=.04). At week 6, 83% (34/41) of participants indicated that they were using the app weekly or more frequently.ConclusionsThe Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT. Further research is needed to establish its effectiveness at and beyond 6 weeks.Trial registrationClinicalTrials.gov NCT03032952; https://clinicaltrials.gov/ct2/show/NCT03032952.

Project description:BackgroundThis paper describes the research protocol for a randomized controlled trial of a multimodal mobile sleep intervention for heavy-drinking young adults. Young adults report the highest rates of heavy, risky alcohol consumption and are a priority population for alcohol prevention and intervention efforts. Alcohol strategies that leverage other health concerns and use technology may offer an innovative solution. Poor sleep is common among young adults and is a risk factor for developing an alcohol use disorder. Moreover, young adults are interested in information to help them sleep better, and behavioral sleep interventions address alcohol use as a standard practice.ObjectiveThe primary aim of this study is to assess the effectiveness of a 2-week multimodal mobile sleep intervention for reducing drinks consumed per week among heavy-drinking young adults. We will explore the effects on alcohol-related consequences, assessing quantitative and qualitative sleep characteristics as secondary aims. The study's goals are to identify the optimal combination of sleep intervention components for improving drinking outcomes, the feasibility and acceptability of these components, and the potential mechanisms by which these components may promote alcohol behavior change.MethodsYoung adults (aged 18-25 years) who report recent heavy drinking will be randomly assigned to one of three conditions: mobile sleep hygiene advice (n=30), mobile sleep hygiene advice and sleep and alcohol diary self-monitoring (n=30), or mobile sleep hygiene advice, sleep and alcohol diary self-monitoring, and sleep and alcohol data feedback (n=60). For the feedback component, participants will complete two web-based sessions with a health coach during which they will receive summaries of their sleep and alcohol data, and the potential association between them along with brief advice tailored to their data. All participants will wear sleep and alcohol biosensors daily for 2 weeks for objective assessments of these outcomes.ResultsThe study was funded by the National Institutes of Health in May 2018. Recruitment began in December 2018 and will be concluded in Spring 2021. As of February 4, 2021, we have enrolled 110 participants.ConclusionsUltimately, this research could result in an efficacious, low-cost intervention with broad population reach through the use of technology. In addition, this intervention may substantially impact public health by reducing alcohol use disorder risk at a crucial developmental stage.Trial registrationClinicalTrials.gov NCT03658954; https://clinicaltrials.gov/ct2/show/NCT03658954.International registered report identifier (irrid)DERR1-10.2196/26557.

Project description:BackgroundYoung adults' drinking habits commonly exceed recommendations for low-risk drinking, which may have a negative effect on their mental, social, and physical health. As smartphones are highly accessible to young adults, mobile apps could be used to support young adults to develop low-risk drinking habits and improve their general health.ObjectiveThe objective of this study is to evaluate the effectiveness of Boozebuster, a self-guided mobile app based on healthy lifestyle-related components that aim to develop and maintain low-risk drinking habits among young adults.MethodsThis two-arm, parallel-group randomized controlled trial will investigate whether a 6-week self-guided mobile intervention (Boozebuster) targeting drinking behavior is more effective than a minimal intervention consisting of an educational website on alcohol use and its consequences for young adults. We will recruit 506 young adults (aged 18-30 years) from the Netherlands via an open recruitment strategy by using an open access website. All outcomes will be self-assessed through questionnaires. The primary outcome is the quantity and frequency of alcohol consumption in standard drinks (10 g ethanol per standard drink) per month (timeline follow-back [TLFB]). Secondary outcomes include binge-drinking sessions per month, alcohol-related problem severity (Rutgers Alcohol Problem Index), cannabis use frequency and quantity in grams (TLFB), depressive symptoms (Center for Epidemiological Studies Depression Scale), perceived stress (Perceived Stress Scale), engagement (Twente Engagement with eHealth Technologies Scale), readiness to change (Readiness to Change Questionnaire), mental well-being (Warwick-Edinburgh Mental Wellbeing Scale), trauma and COVID-19-related trauma (Short-Form Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition), impulsivity (Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency Impulsive Behavior Scale), study or work performance (Individual Work Performance Questionnaire), and treatment adherence. Baseline (T0), 6-week postbaseline (T1), and 3-month postbaseline (T2) assessments will be conducted and analyzed on the basis of the intention-to-treat principle using multilevel mixed modeling analyses.ResultsRecruitment began in September 2020. We received 933 registrations via our study information website; 506 participants have completed the T0 assessment, 336 participants have completed the T1 assessment, and 308 participants have completed the T2 assessment as of May 2021. The study is still in progress, and results will be reported in 2021 and 2022.ConclusionsSelf-guided mobile interventions based on a lifestyle approach might be an attractive approach for young adults due to their preference on self-reliance, healthy living, and increased perceived anonymity. Such interventions are yet understudied, and it is known that interventions addressing solely problem drinking are less appealing to young adults. We hypothesize that the Boozebuster mobile app will effectively reduce drinking levels compared to an alcohol educational website (control condition). If effective, our intervention could be an inexpensive and scalable public health intervention to improve drinking habits in young adults.Trial registrationNetherlands Trial Register NL8828; https://www.trialregister.nl/trial/8828.International registered report identifier (irrid)DERR1-10.2196/29750.

Project description:BackgroundCollege athletes are a group often affected by anxiety. Few interventional studies have been conducted to address the anxiety issues in this population.ObjectiveWe conducted a mobile-delivered mindfulness intervention among college athletes to study its feasibility and efficacy in lowering their anxiety level and improving their mindfulness (measured by the Five Facet Mindfulness Questionnaire [FFMQ]).MethodsIn April 2019, we recruited 290 college athletes from a public university in Shanghai, China, and 288 of them were randomized into an intervention group and a control group (closed trial), with the former (n=150) receiving a therapist-guided, smartphone-delivered mindfulness-based intervention and the latter receiving mental health promotion messages (n=138). We offered in-person instructions during the orientation session for the intervention group in a classroom, with the therapist interacting with the participants on the smartphone platform later during the intervention. We used generalized linear modeling and the intent-to-treat approach to compare the 2 groups' outcomes in dispositional anxiety, precompetition anxiety, and anxiety during competition, plus the 5 dimensions of mindfulness (measured by the FFMQ).ResultsOur intent-to-treat analysis and generalized linear modeling found no significant difference in dispositional anxiety, precompetition anxiety, or anxiety during competition. Only the "observation" facet of mindfulness measures had a notable difference between the changes experienced by the 2 groups, whereby the intervention group had a net gain of .214 yet fell short of reaching statistical significance (P=.09). Participants who specialized in group sports had a higher level of anxiety (β=.19; SE=.08), a lower level of "nonjudgemental inner experience" in FFMQ (β=-.07; SE=.03), and a lower level of "nonreactivity" (β=-.138; SE=.052) than those specializing in individual sports.ConclusionsNo significant reduction in anxiety was detected in this study. Based on the participant feedback, the time availability for mindfulness practice and session attendance for these student athletes in an elite college could have compromised the intervention's effectiveness. Future interventions among this population could explore a more student-friendly time schedule (eg, avoid final exam time) or attempt to improve cognitive and scholastic outcomes.Trial registrationChinese Clinical Trial Registry ChiCTR1900024449; https://www.chictr.org.cn/showproj.html?proj=40865.

Project description:BackgroundAdolescents and young adults (AYAs) with cancer are at risk of poor psychosocial outcomes. AYAs grew up with the internet and digital technology, and mobile Health (mHealth) psychosocial interventions have the potential to overcome care access barriers.ObjectiveThis pilot randomized controlled trial (RCT) aimed to establish the feasibility, acceptability, and preliminary efficacy of a fully automated mobile app version of the Promoting Resilience in Stress Management intervention (mPRISM). Promoting Resilience in Stress Management is an evidence-based intervention developed in collaboration with AYAs, based on stress and coping theory, resilience theory, and evidence-based coping strategies. We hypothesized that mPRISM would be feasible, acceptable, and appropriate.MethodsThis is a parallel, 2-arm, single-site pilot RCT with a waitlist control design. The study will recruit 80 AYAs with cancer from a clinic. Eligible AYAs are aged 12 to 25 years, within 12 months of a new cancer diagnosis, receiving chemotherapy or radiation therapy, speak, read, or write in English, and are cognitively able to participate in study procedures. Recruitment by clinical research coordinators will occur remotely by phone, video, or text. Participants will be randomized to psychosocial usual care (UC) alone or UC plus mPRISM for an 8-week intervention period, and will remain unblinded to study condition. Enrolled participants will complete surveys at baseline before randomization, 8 weeks, and 3-month follow-up. Using a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. Those in the UC arm will complete 2 additional measurement points at immediate posttreatment and 3 months later. The primary outcomes of interest are feasibility, defined as ≥60% enrollment and ≥70% retention (ie, percentage of participants who completed the study), and "feasibility, acceptability, and appropriateness" as defined by cut-off scores ≥4/5 on 3 brief validated implementation outcome measures (feasibility of implementation measure, acceptability of intervention measure [AIM], intervention appropriateness measure [IAM]). We will apply top-box scoring for the implementation measures. Exploratory outcomes of interest include patient-reported health-related quality of life, resilience, distress, anxiety, depression, pain, and sleep. We will conduct an intention-to-treat analysis to compare the outcomes of the mPRISM arm versus the control arm with covariate-adjusted regression models. We will summarize individual digital usage metrics using descriptive statistics.ResultsSince September 2023, we have enrolled 20 participants and recruitment is ongoing.ConclusionsAlthough our previous work suggests AYAs with cancer are interested in mHealth psychosocial interventions, such interventions have not yet been sufficiently evaluated or implemented among AYA oncology patients. mPRISM may serve as a potential mHealth intervention to fill this gap. In this study, we will test the feasibility, acceptability, and preliminary efficacy of mPRISM. This work will inform future larger-scale RCTs powered for efficacy outcomes.Trial registrationClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902.International registered report identifier (irrid)DERR1-10.2196/57950.

Project description:BackgroundDelivery of preventative interventions via mobile phone apps offers an effective and accessible way to address the global priority of improving the mental health of adolescents and young adults. A proven risk factor for anxiety and depression is elevated worry and rumination, also known as repetitive negative thinking (RNT).ObjectiveThis was a prevention mechanism trial that aimed to investigate whether an RNT-targeting self-help mobile phone app (MyMoodCoach) reduces worry and rumination in young adults residing in the United Kingdom. A secondary objective was to test whether the app reduces symptoms of anxiety and depression and improves well-being.MethodsA web-based, single-blind, 2-arm parallel-group randomized controlled trial was conducted with 236 people aged between 16 and 24 years, who self-reported high levels of worry or rumination. Eligible participants were randomized to an active intervention group (usual practice, plus up to 6 weeks of using the RNT-targeting mobile app, n=119) or a waitlist control group (usual practice with no access to the app until after 6 weeks, n=117). The primary outcome was changes in worry and rumination 6 weeks after randomization. Secondary outcomes included changes in well-being and symptoms of anxiety and depression after 6 weeks and changes in all measures after 12 weeks.ResultsParticipants randomly allocated to use the RNT-targeting self-help app showed significantly lower levels of rumination (mean difference -2.92, 95% CI -5.57 to -0.28; P=.03; ηp2=0.02) and worry (mean difference -3.97, 95% CI -6.21 to -1.73; P<.001; ηp2=0.06) at 6-week follow-up, relative to the waitlist control. Similar differences were observed for well-being (P<.001), anxiety (P=.03), and depression (P=.04). The waitlist control group also showed improvement when given access to the app after 6 weeks. Improvements observed in the intervention group after 6 weeks of using the app were maintained at the 12-week follow-up point.ConclusionsThe MyMoodCoach app had a significant positive effect on worry and rumination, well-being, anxiety, and depression in young adults, relative to waitlist controls, providing proof-of-principle that an unguided self-help app can effectively reduce RNT. This app, therefore, has potential for the prevention of anxiety and depression although longer-term effects on incidence need to be directly evaluated.Trial registrationClinicalTrials.gov NCT04950257; https://www.clinicaltrials.gov/ct2/show/NCT04950257.International registered report identifier (irrid)RR2-10.1186/s12888-021-03536-0.

Dataset Information

Efficacy of a Mobile App-Based Intervention for Young Adults With Anxiety Disorders: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Intervention

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Efficacy of a Mobile App-Based Intervention for Young Adults With Anxiety Disorders: A Randomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets