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Promotion of mental health in young adults via mobile phone app: study protocol of the ECoWeB (emotional competence for well-being in Young adults) cohort multiple randomised trials.

ABSTRACT: BACKGROUND:Promoting well-being and preventing poor mental health in young people is a major global priority. Building emotional competence (EC) skills via a mobile app may be an effective, scalable and acceptable way to do this. However, few large-scale controlled trials have examined the efficacy of mobile apps in promoting mental health in young people; none have tailored the app to individual profiles. METHOD/DESIGN:The Emotional Competence for Well-Being in Young Adults cohort multiple randomised controlled trial (cmRCT) involves a longitudinal prospective cohort to examine well-being, mental health and EC in 16-22?year olds across 12?months. Within the cohort, eligible participants are entered to either the PREVENT trial (if selected EC scores at baseline within worst-performing quartile) or to the PROMOTE trial (if selected EC scores not within worst-performing quartile). In both trials, participants are randomised (i) to continue with usual practice, repeated assessments and a self-monitoring app; (ii) to additionally receive generic cognitive-behavioural therapy self-help in app; (iii) to additionally receive personalised EC self-help in app. In total, 2142 participants aged 16 to 22?years, with no current or past history of major depression, bipolar disorder or psychosis will be recruited across UK, Germany, Spain, and Belgium. Assessments take place at baseline (pre-randomisation), 1, 3 and 12?months post-randomisation. Primary endpoint and outcome for PREVENT is level of depression symptoms on the Patient Health Questionnaire-9 at 3?months; primary endpoint and outcome for PROMOTE is emotional well-being assessed on the Warwick-Edinburgh Mental Wellbeing Scale at 3?months. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and cost-effectiveness are secondary outcomes. Compliance, adverse events and potentially mediating variables will be carefully monitored. CONCLUSIONS:The trial aims to provide a better understanding of the causal role of learning EC skills using interventions delivered via mobile phone apps with respect to promoting well-being and preventing poor mental health in young people. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective Mobile-health public health strategies for preventing poor mental health and promoting well-being. TRIAL REGISTRATION:ClinicalTrials.gov ( www.clinicaltrials.org ). Number of identification: NCT04148508 November 2019.

SUBMITTER: Newbold A

PROVIDER: S-EPMC7510072 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Promotion of mental health in young adults via mobile phone app: study protocol of the ECoWeB (emotional competence for well-being in Young adults) cohort multiple randomised trials.

Newbold A A Warren F C FC Taylor R S RS Hulme C C Burnett S S Aas B B Botella C C Burkhardt F F Ehring T T Fontaine J R J JRJ Frost M M Garcia-Palacios A A Greimel E E Hoessle C C Hovasapian A A Huyghe Vei V Lochner J J Molinari G G Pekrun R R Platt B B Rosenkranz T T Scherer K R KR Schlegel K K Schulte-Korne G G Suso C C Voigt V V Watkins E R ER

BMC psychiatry 20200922 1

<h4>Background</h4>Promoting well-being and preventing poor mental health in young people is a major global priority. Building emotional competence (EC) skills via a mobile app may be an effective, scalable and acceptable way to do this. However, few large-scale controlled trials have examined the efficacy of mobile apps in promoting mental health in young people; none have tailored the app to individual profiles.<h4>Method/design</h4>The Emotional Competence for Well-Being in Young Adults cohor ...[more]

PMID: 32962684

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Project description:BackgroundPromoting well-being and preventing poor mental health in young people is a major global priority. Building emotional competence skills via a mobile app may be an effective, scalable and acceptable way to do this. A particular risk factor for anxiety and depression is elevated worry and rumination (repetitive negative thinking, RNT). An app designed to reduce RNT may prevent future incidence of depression and anxiety.Method/designThe Emotional Competence for Well-Being in Young Adults study developed an emotional competence app to be tested via randomised controlled trials in a longitudinal prospective cohort. This off-shoot study adapts the app to focus on targeting RNT (worry, rumination), known risk factors for poor mental health. In this study, 16-24 year olds in the UK, who report elevated worry and rumination on standardised questionnaires are randomised to (i) receive the RNT-targeting app immediately for 6 weeks (ii) a waiting list control who receive the app after 6 weeks. In total, the study will aim to recruit 204 participants, with no current diagnosis of major depression, bipolar disorder or psychosis, across the UK. Assessments take place at baseline (pre-randomisation), 6 and 12 weeks post-randomisation. Primary endpoint and outcome for the study is level of rumination assessed on the Rumination Response Styles Questionnaire at 6 weeks. Worry, depressive symptoms, anxiety symptoms and well-being are secondary outcomes. Compliance, adverse events and potentially mediating variables will be carefully monitored.DiscussionThis trial aims to better understand the benefits of tackling RNT via an mobile phone app intervention in young people. This prevention mechanism trial will establish whether targeting worry and rumination directly via an app provides a feasible approach to prevent depression and anxiety, with scope to become a widescale public health strategy for preventing poor mental health and promoting well-being in young people.Trial registrationClinicalTrials.gov , NCT04950257 . Registered 6 July 2021 - Retrospectively registered.

Project description:BACKGROUND:Few people successfully maintain lost weight over the longer term. Mobile phones have the potential to deliver weight loss management programs that can encourage self-monitoring while also providing some behavioral therapy to assist users in developing personal skills that may be necessary for improved longer term weight loss maintenance. OBJECTIVE:The aim of this study was to evaluate a program supporting weight maintenance, which uses a behaviorally based mobile phone app to manage weight, food, exercise, mood, and stress. METHODS:In a randomized controlled trial over 24 weeks, the full version of the app (MotiMate) was compared with a control app (monitoring only; excluding mood and stress) for its effect on weight, diet, and psychological well-being. Both apps had the same visual appearance and were designed to deliver all intervention content without face-to-face contact. The control version included features to track weight, food intake, and exercise with limited feedback and no encouraging/persuasive features. The intervention app included more persuasive and interactive features to help users track their weight, food intake, and physical activity and prompted users to enter data each day through notifications and included a mood and stress workshopping tool. Participants were recruited through advertising and existing databases. Clinic visits occurred at baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. At all visits, the clinical trial manager recorded body weight, and participants then completed a computer-delivered survey, which measured psychological and lifestyle outcomes. Objective app usage data were recorded throughout the trial. RESULTS:A total of 88 adults who had lost and maintained at least 5% of their body weight within the last 2 years were randomized (45 MotiMate and 43 control). Overall, 75% (66/88) were female, and 69% (61/88) completed week 24 with no differences in dropout by condition (χ21,87=0.7, P=.49). Mixed models suggested no significant changes in weight or psychological outcomes over 24 weeks regardless of condition. Of 61 completers, 53% (32/61) remained within 2% of their starting weight. Significant increases occurred over 24 weeks for satisfaction with life and weight loss self-efficacy regardless of app condition. Diet and physical activity behaviors did not vary by app or week. Negative binomial models indicated that those receiving the full app remained active users of the app for 46 days longer than controls (P=.02). Users of the full version of the app also reported that they felt more supported than those with the control app (P=.01). CONCLUSIONS:Although some aspects of the intervention app such as usage and user feedback showed promise, there were few observable effects on behavioral and psychological outcomes. Future evaluation of the app should implement alternative research methods or target more specific populations to better understand the utility of the coping interface. TRIAL REGISTRATION:Australia New Zealand Clinical Trials Registry ACTRN12614000474651; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366120.

Project description:BackgroundCommercial smartphone apps designed to promote emotional well-being are becoming increasingly popular, but few apps have been empirically validated.ObjectiveThis study examined the feasibility and effectiveness of a self-guided app designed to reduce daily stress via positive messaging and tailored short inspirational talks (ie, peps).MethodsA total of 166 participants (n=112, 67.5% female; mean age 38.48, SD 6.73 years) were recruited through social media advertising and randomized into an intervention (Hey Lemonade app plus twice daily mood monitoring using the Multidimensional Mood Questionnaire [MDMQ]) or active control (twice daily mood monitoring [MDMQ]) group. Primary (coping self-efficacy [CSE]; 3 subscales) and secondary outcomes (vitality, satisfaction with life, perceived stress, positive and negative affect, and hassles and uplifts) were measured at the baseline (week 1) and end point (week 4). The app evaluation questions were assessed at week 2. All interactions and measurements were collected on the internet and through the apps.ResultsIn total, of 166 participants, 125 (75.3%) completed the trial. There were no differences in dropout rates between the groups (62/81, 76% intervention; 63/85, 74% control). There were significant group-by-time interactions for vitality and hassles but no significant effect for CSE total (P=.05). For the intervention group, the change from baseline to week 4 was significant for vitality (P=.002) and hassles (P=.004), CSE total (P=.008), and CSE Emotional subscale (P=.02). For the control group, any changes over 4 weeks were not significant for any outcome. There was a significant group-by-time interaction for MDMQ calmness (P=.04). By week 4, calmness was significantly higher in the intervention group (P=.046). Of those in the intervention group at week 2 (n=68), 39 (57%) participants recommended the app and 41 (60%) participants wanted to continue using it. Pep talks and customizable voice options were the most popular features.ConclusionsParticipants who had access to the smartphone app on an as-needed basis over the 4-week trial showed significant improvements in emotional well-being indicators. More broadly, this suggests that simple accessible solutions may generate meaningful well-being outcomes. Whether these changes are sustained and can be generalized to other population groups is yet to be determined.Trial registrationAustralian and New Zealand Clinical Trials Registry (ANZCTR) 12622001005741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384304&isReview=true.

Project description:BackgroundThe COVID-19 pandemic is likely to increase anxiety and distress in young people worldwide. It is important to prioritize mental health during crisis events to mitigate the negative and often long-term effects of the crises on young people, families, and society. Mental health and well-being apps represent a scalable approach for improving psychological outcomes in young people and have potential to improve the equity of service access.ObjectiveThe Whitu: 7 Ways in 7 Days well-being app was recently developed by our group to address the urgent need for innovative approaches to reach young New Zealanders who are struggling to cope with the COVID-19 pandemic. The aim of this study is twofold: to evaluate the acceptability of the prototype app and to examine the effectiveness of the refined app at improving mental and emotional well-being and reducing depression, anxiety, and stress in young people in New Zealand.MethodsA two-phase mixed methods study will be undertaken to achieve these aims. During the first phase, 20 young people aged 16-30 years (including those of Māori and Pacific ethnicity) will participate in a qualitative study to help refine the prototype app. During the second phase, 90 young people aged 16-30 years will participate in a randomized waitlist-controlled trial (RCT) to evaluate the efficacy of the refined Whitu app at 4 weeks and 3 months after baseline. Outcomes will be evaluated using validated web-based questionnaires at baseline, 4 weeks, and 3 months.ResultsThe study received ethics approval in May 2020, and recruitment for the focus groups commenced in June 2020. Recruitment for the RCT is expected to commence in October 2020. Participants for both study phases will be recruited via social media and web-based communities. Data collection for the RCT is expected to be completed by January 2021, and analyses are expected to be completed by March 2021. Linear mixed modelling will be used to determine between-group differences in psychological outcomes.ConclusionsThere is an urgent need to develop culturally appropriate, scalable mental health interventions to address the psychological consequences of the COVID-19 pandemic. In this study, we will develop and test an evidence-based well-being app that, if effective, can be made available to all young people in New Zealand and internationally.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12620000516987); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379597.International registered report identifier (irrid)PRR1-10.2196/23716.

Project description:ObjectiveDescribe the development and pretest of a prototype multibehavioural change app MAMA-EMPOWER.DesignMixed-methods study reporting three phases: (1) contextual enquiry included stakeholder engagement and qualitative interviews with Aboriginal women, (2) value specification included user-workshop with an Aboriginal researcher, community members and experts, (3) codesign with Aboriginal researchers and community members, followed by a pretest of the app with Aboriginal women, and feedback from qualitative interviews and the user-Mobile Application Rating Scale (U-MARS) survey tool.SettingsAboriginal women and communities in urban and regional New South Wales, Australia.ParticipantsPhase 1: interviews, 8 Aboriginal women. Phase 2: workshop, 6 Aboriginal women. Phase 3: app trial, 16 Aboriginal women. U-MARS, 5 Aboriginal women.ResultsPhase 1 interviews revealed three themes: current app use, desired app characteristics and implementation. Phase 2 workshop provided guidance for the user experience. Phase 3 app trial assessed all content areas. The highest ratings were for information (mean score of 3.80 out of 5, SD=0.77) and aesthetics (mean score of 3.87 with SD of 0.74), while functionality, engagement and subjective quality had lower scores. Qualitative interviews revealed the acceptability of the app, however, functionality was problematic.ConclusionsDeveloping a mobile phone app, particularly in an Aboriginal community setting, requires extensive consultation, negotiation and design work. Using a strong theoretical foundation of behavioural change technique's coupled with the consultative approach has added rigour to this process. Using phone apps to implement behavioural interventions in Aboriginal community settings remains a new area for investigation. In the next iteration of the app, we aim to find better ways to personalise the content to women's needs, then ensure full functionality before conducting a larger trial. We predict the process of development will be of interest to other health researchers and practitioners.

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.

Project description:Interventions to prevent osteoporosis by increasing dairy intake or physical activity in young women have been limited to increasing osteoporosis knowledge and awareness. However, findings have shown that this does not always lead to a change in behaviors. Self-monitoring using mobile devices in behavioral interventions has yielded significant and positive outcomes. Yet, to our knowledge, mobile self-monitoring has not been used as an intervention strategy to increase calcium intake, particularly in young women, for better bone health outcomes.As development and testing of mobile app-based interventions requires a sequence of steps, our study focused on testing the acceptability and usability of Calci-app, a dietary app to self-monitor calcium consumption, before it is used in a behavioral change intervention in young women aged 18-25 years.Calci-app development followed 4 steps: (1) conceptualization, (2) development and pretesting, (3) pilot testing, and (4) mixed methods evaluation.We present the development process of Calci-app and evaluation of the acceptability and usability of the app in young women. Overall, 78% (31/40) of study participants completed the 5-day food record with high compliance levels (defined as more than 3 days of full or partial completion). There was a significant reduction in the proportion of participants completing all meal entries over the 5 days (P=.01). Participants generally found Calci-app easy and convenient to use, but it was time-consuming and they expressed a lack of motivation to use the app.We present a detailed description of the development process of Calci-app and an evaluation of its usability and acceptability to self-monitor dietary calcium intake. The findings from this preliminary study demonstrated acceptable use of Calci-app to self-monitor calcium consumption. However, for regular and long-term use the self-monitoring function in Calci-app could be expanded to allow participants to view their total daily calcium intake compared with the recommended daily intake. Additionally, to facilitate sustainable lifestyle behavior modifications, a combination of various behavior change techniques should be considered, such as education, goal setting, and advice to participants based on their stage of change. The feedback on barriers and facilitators from testing Calci-app will be used to design a bone health mHealth intervention to modify risky lifestyle behaviors in young women for better bone health outcomes.

Project description:BACKGROUND: The use of mobile phones, and specifically smartphones, in the last decade has become more and more prevalent. The latest mobile phones are equipped with comprehensive features that can be used in health care, such as providing rapid access to up-to-date evidence-based information, provision of instant communications, and improvements in organization. The estimated number of health care apps for mobile phones is increasing tremendously, but previous research has highlighted the lack of critical appraisal of new apps. This lack of appraisal of apps has largely been due to the lack of clinicians with technical knowledge of how to create an evidence-based app. OBJECTIVE: We discuss two freely available methodologies for developing Web-based mobile phone apps: a website builder and an app builder. With these, users can program not just a Web-based app, but also integrate multimedia features within their app, without needing to know any programming language. METHODS: We present techniques for creating a mobile Web-based app using two well-established online mobile app websites. We illustrate how to integrate text-based content within the app, as well as integration of interactive videos and rich site summary (RSS) feed information. We will also briefly discuss how to integrate a simple questionnaire survey into the mobile-based app. A questionnaire survey was administered to students to collate their perceptions towards the app. RESULTS: These two methodologies for developing apps have been used to convert an online electronic psychiatry textbook into two Web-based mobile phone apps for medical students rotating through psychiatry in Singapore. Since the inception of our mobile Web-based app, a total of 21,991 unique users have used the mobile app and online portal provided by WordPress, and another 717 users have accessed the app via a Web-based link. The user perspective survey results (n=185) showed that a high proportion of students valued the textbook and objective structured clinical examination videos featured in the app. A high proportion of students concurred that a self-designed mobile phone app would be helpful for psychiatry education. CONCLUSIONS: These methodologies can enable busy clinicians to develop simple mobile Web-based apps for academic, educational, and research purposes, without any prior knowledge of programming. This will be beneficial for both clinicians and users at large, as there will then be more evidence-based mobile phone apps, or at least apps that have been appraised by a clinician.

Dataset Information

Promotion of mental health in young adults via mobile phone app: study protocol of the ECoWeB (emotional competence for well-being in Young adults) cohort multiple randomised trials.

Publications

Promotion of mental health in young adults via mobile phone app: study protocol of the ECoWeB (emotional competence for well-being in Young adults) cohort multiple randomised trials.

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