Dataset Information

App to support Recovery in Early Intervention Services (ARIES) study: protocol of a feasibility randomised controlled trial of a self-management Smartphone application for psychosis.

ABSTRACT:

Introduction

Mental health interventions delivered through digital technology have potential applications in promoting recovery and improving outcomes among people in the early stages of psychosis. Self-management approaches are recommended for the treatment of psychosis and could be delivered via applications (apps) installed on Smartphones to provide low-cost accessible support. We describe the protocol for a feasibility trial investigating a self-management Smartphone app intervention for adults using Early Intervention in Psychosis (EIP) services.

Methods and analysis

In this feasibility randomised controlled trial, 40 participants will be recruited from EIP services in London and Surrey. Twenty participants will be randomised to receive a supported self-management Smartphone app (My Journey 3) plus Treatment As Usual (TAU), while the other 20 participants will receive TAU only. The primary objective of this study is to evaluate the feasibility of conducting a full-scale trial of this intervention in EIP services. Participant data will be collected at baseline and at two follow-up assessments conducted 4?months and 12 months post-baseline. Analysed outcome measures will include relapse of psychosis (operationalised as admission to a hospital or community acute alternative), mental health and well-being, recovery, quality of life and psychopathology. Semi-structured interviews with participants and EIP service clinicians will additionally explore experiences of using My Journey 3 and participating in the trial and suggestions for improving the intervention.

Ethics and dissemination

The App to support Recovery in Early Intervention Services study has been reviewed and approved by the National Research Ethics Service Committee London-Brent (Research Ethics Committee reference: 15/LO/1453). The findings of this study will be disseminated through peer-reviewed scientific journals and conferences, magazines and web publications.

Trial registration number

ISRCTN10004994.

SUBMITTER: Steare T

PROVIDER: S-EPMC6528051 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

App to support Recovery in Early Intervention Services (ARIES) study: protocol of a feasibility randomised controlled trial of a self-management Smartphone application for psychosis.

Steare Thomas T O'Hanlon Puffin P Eskinazi Michelle M Osborn David D Lloyd-Evans Brynmor B Jones Rebecca R Rostill Helen H Amani Sarah S Johnson Sonia S

BMJ open 20190320 3

<h4>Introduction</h4>Mental health interventions delivered through digital technology have potential applications in promoting recovery and improving outcomes among people in the early stages of psychosis. Self-management approaches are recommended for the treatment of psychosis and could be delivered via applications (apps) installed on Smartphones to provide low-cost accessible support. We describe the protocol for a feasibility trial investigating a self-management Smartphone app intervention ...[more]

PMID: 30898825

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Project description:ObjectivesTo test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.DesignA two-arm unblinded feasibility RCT.SettingSix NHS EIP services in England.ParticipantsAdults using EIP services who own an Android Smartphone. Participants were recruited until the recruitment target was met (n=40).InterventionsParticipants were randomised with a 1:1 allocation to one of two conditions: (1) treatment as usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone. My Journey 3 features a range of self-management components including access to digital recovery and relapse prevention plans, medication tracking and symptom monitoring. My Journey 3 use was at the users' discretion and was supported by EIP service clinicians. Participants had access for a median of 38.1 weeks.Primary and secondary outcome measuresFeasibility outcomes included recruitment, follow-up rates and intervention engagement. Participant data on mental health outcomes were collected from clinical records and from research assessments at baseline, 4 months and 12 months.Results83% and 75% of participants were retained in the trial at the 4-month and 12-month assessments. All treatment group participants had access to My Journey 3 during the trial, but technical difficulties caused delays in ensuring timely access to the intervention. The median number of My Journey 3 uses was 16.5 (IQR 8.5 to 23) and median total minutes spent using My Journey 3 was 26.8 (IQR 18.3 to 57.3). No serious adverse events were reported.ConclusionsRecruitment and retention were feasible. Within a trial context, My Journey 3 could be successfully delivered to adults using EIP services, but with relatively low usage rates. Further evaluation of the intervention in a larger trial may be warranted, but should include attention to implementation.Trial registrationISRCTN10004994.

Project description:Background:Social support has an important role in successful weight loss. The aim of this study was to assess the feasibility and acceptability of an app-, web- and social support-based intervention in supporting adults with obesity to achieve weight loss. Methods:The intervention and evaluation methods were tested in a feasibility randomised controlled trial. Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ??30?kg/m2 were recruited and randomised 2:1 (intervention to control). The feasibility and acceptability of the intervention and trial methods were assessed against pre-specified progression criteria, via process, economic and outcome evaluation. Three primary outcomes were explored: BMI, diet and physical activity, as well as a number of secondary outcomes. The intervention group had access to the HelpMeDoIt! intervention for 12?months. This encouraged them to (i) set goals, (ii) monitor progress and (iii) harness social support by inviting 'helpers' from their existing social network. The control group received a healthy lifestyle leaflet. Results:One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12?months. The intervention and trial methods were feasible and acceptable. Participants and helpers were generally positive. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it. Interview data indicated that HelpMeDoIt! promoted social support from existing social networks to support weight loss. This support was often given outside of the app.Outcomes were compared using linear regression models, with randomised group, the baseline measurement of the outcome, age and gender as predictor variables. These analyses were exploratory and underpowered to detect effects. However, all pre-specified primary outcome effects (BMI, diet and physical activity) had wide confidence intervals and were therefore consistent with clinically relevant benefits. Objective physical activity measures perhaps showed most potential (daily step count (p = 0.098; 1187 steps [-?180, 2555])) and sedentary time (p = 0.022; -?60.8?min [-?110.5, -?11.0]). However, these outcomes were poorly completed. Conclusions:The study demonstrated that a novel social support intervention involving support from participants' close social networks, delivered via app and website, has potential to promote weight loss and is feasible and acceptable. Trial registration:ISRCTN, ISRCTN85615983. Registered 25 September 2014.

Project description:BackgroundYoung adults with asthma often report low adherence to inhaled corticosteroids (ICS), leading to uncontrolled symptoms and poor disease outcomes. Technology-enabled digital supports such as mobile health (mHealth) asthma smartphone apps have the potential to support adherence to ICS and asthma self-management. There is a need for feasibility studies to determine the usability, acceptability, and feasibility of these interventions. In addition, it is essential to determine the feasibility of recruiting and retaining young adults to plan future efficacy and effectiveness trials and therefore, establish evidence-based asthma apps.ObjectiveThis study aimed to determine (1) the feasibility of recruiting and retaining young adults to a trial and (2) the usability, acceptability, and feasibility of using the AsthmaMD app to support adherence to ICS in a population of young adults living with asthma.MethodsA multi-methods feasibility study was conducted. Young adults aged 18-30 years with asthma and current prescription for ICS were eligible and invited to take part through a university circular email, social media, and general practice sites. Participation involved completing a baseline self-report questionnaire, downloading and using the AsthmaMD app for 2 weeks, and completing the follow-up assessment, including self-report and open-ended questions about participants' experience of using the app. Primary outcomes included participant recruitment and retention and the usability, acceptability, and feasibility of using AsthmaMD. Quantitative self-report data were analyzed using descriptive statistics, and qualitative open-ended data were analyzed using inductive reflexive thematic analysis.ResultsA total of 122 young adults (females, n=101, 82.8%) with a mean age of 24.4 (SD 3.8) years were recruited and they completed baseline measures. Of the 122 young adults, 59 (48.4%) completed the study. The AsthmaMD app received a mean score of 63.1/100 (SD 20.1) on the System Usability Scale (ie, a standardized measure of usability for technology-based apps), and an overall user satisfaction score of 5.8/10 (SD 2.2). Of the 59 participants who completed the study, 49 (83%) participants used the app ≥1 day per week. Two main themes were identified in the qualitative analysis of user experiences: (1) learning how to use the app to suit the individual and (2) benefits and relevance of using the app.ConclusionsThe findings from this study indicate that it is feasible to recruit and retain young adults to examine efficacy and effectiveness in a future trial and that young adults living with asthma may find AsthmaMD to be usable, acceptable, and feasible to support adherence to ICS. Our findings also identified opportunities to further optimize the usability of AsthmaMD and similar apps. Based on our findings, we recommend providing more accessible information on how to use the app and replacing medical terminology with simplified language within the app to improve usability.Trial registrationISRCTN Registry ISRCTN11295269; https://www.isrctn.com/ISRCTN11295269.

Project description:IntroductionHelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s).AimTo test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals.Methods and analysis12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)> 30 kg/m2 and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention.Ethics and disseminationThe protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations.Trial registration numberISRCTN85615983.

Project description:BackgroundImpulsePal is a theory-driven (dual-process), evidence-informed, and person-centered smartphone app intervention designed to help people manage impulsive processes that prompt unhealthy eating to facilitate dietary change and weight loss.ObjectiveThe aims of this study were to (1) assess the feasibility of trial procedures for evaluation of the ImpulsePal intervention, (2) estimate standard deviations of outcomes, and (3) assess usability of, and satisfaction with, ImpulsePal.MethodsWe conducted an individually randomized parallel two-arm nonblinded feasibility trial. The eligibility criteria included being aged ≥16 years, having a body mass index of ≥25 kg/m2, and having access to an Android-based device. Weight was measured (as the proposed primary outcome for a full-scale trial) at baseline, 1 month, and 3 months of follow-up. Participants were randomized in a 2:1 allocation ratio to the ImpulsePal intervention or a waiting list control group. A nested action-research study allowed for data-driven refinement of the intervention across 2 cycles of feedback.ResultsWe screened 179 participants for eligibility, and 58 were randomized to the intervention group and 30 to the control group. Data were available for 74 (84%, 74/88) participants at 1 month and 67 (76%, 67/88) participants at 3 months. The intervention group (n=43) lost 1.03 kg (95% CI 0.33 to 1.74) more than controls (n=26) at 1 month and 1.01 kg (95% CI -0.45 to 2.47) more than controls (n=43 and n=24, respectively) at 3 months. Feedback suggested changes to intervention design were required to (1) improve receipt and understanding of instructions and (2) facilitate further engagement with the app and its strategies.ConclusionsThe evaluation methods and delivery of the ImpulsePal app intervention are feasible, and the trial procedures, measures, and intervention are acceptable and satisfactory to the participants.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 14886370; http://www.isrctn.com/ISRCTN14886370 (Archived by WebCite at http://www.webcitation.org/76WcEpZ51).

Project description:BackgroundAscites is a common, painful, and serious complication of cirrhosis. Body weight is a reliable proxy for ascites volume; therefore, daily weight monitoring is recommended to optimize ascites management.ObjectiveThis study aims to evaluate the feasibility of a smartphone app in facilitating outpatient ascites management.MethodsIn this feasibility study, patients with cirrhotic ascites requiring active management were identified in both inpatient and outpatient settings. Patients were provided with a Bluetooth-connected scale, which transmitted weight data to a smartphone app and then via the internet to an electronic medical record (EMR). Weights were monitored every weekday. In the event of a weight change of ≥5 lbs in 1 week, patients were called and administered a short symptom questionnaire, and providers received an email alert. The primary outcomes of this study were the percentage of enrolled days during which weight data were successfully transmitted to an EMR and the percentage of weight alerts that prompted responses by the provider.ResultsIn this study, 25 patients were enrolled: 12 (48%) were male, and the mean age was 58 (SD 13; range 35-81) years. A total of 18 (72%) inpatients were enrolled. Weight data were successfully transmitted to an EMR during 71.2% (697/979) of the study enrollment days, with technology issues reported on 16.5% (162/979) of the days. Of a total of 79 weight change alerts fired, 41 (52%) were triggered by weight loss and 38 (48%) were by weight gain. Providers responded in some fashion to 66 (84%) of the weight alerts and intervened in response to 45 (57%) of the alerts, for example, by contacting the patient, scheduling clinic or paracentesis appointments, modifying the diuretic dose, or requesting a laboratory workup. Providers responded equally to weight increase and decrease alerts (P=.87). The staff called patients a mean of 3.7 (SD 3.5) times per patient, and the number of phone calls correlated with technology issues (r=0.60; P=.002). A total of 60% (15/25) of the patients chose to extend their participation beyond 30 days. A total of 17 patient readmissions occurred during the study period, with only 4 (24%) related to ascites.ConclusionsWe demonstrated the feasibility of a smartphone app to facilitate the management of ascites and reported excellent rates of patient and provider engagement. This innovation could enable early therapeutic intervention, thereby decreasing the burden of morbidity and mortality among patients with cirrhosis.

Project description:BACKGROUND:Depersonalisation is the experience of being detached or disconnected from one's experience. Studies suggest that clinically significant levels of depersonalisation are common in individuals who have psychotic symptoms and are associated with increased impairment. However, to date, there have been no studies that have investigated an intervention designed to target clinically significant depersonalisation in such patient groups. This study aims to determine the feasibility and acceptability of a brief intervention targeting clinically significant depersonalisation in those who also have current psychotic symptoms. METHODS/DESIGN:The feasibility of delivering six sessions of cognitive behavioural therapy for depersonalisation in psychosis patients will be evaluated using a single-blinded randomised controlled trial with a treatment as usual control condition. Participants will be assessed at baseline and then randomised to either the treatment or control arm. Participants randomised to the treatment arm will be offered six sessions of individual cognitive behavioural therapy delivered over a maximum of 10 weeks. Therapy will focus on an individualised shared formulation of depersonalisation experiences and behavioural, cognitive, emotional regulation and thinking process strategies to decrease distress associated with depersonalisation. Participants will be assessed again at a 10-week (post-randomisation) follow-up assessment. The primary outcomes of interest will be those assessing the feasibility and acceptability of the intervention including rates of referral, eligibility and acceptance to participate; attendance at therapy sessions and completion of homework tasks; satisfaction with the intervention; maintenance of blinding; and therapist competence. Secondary outcomes will be data on clinical outcome measures of depersonalisation and positive symptoms of psychosis, anxiety, depression and post-traumatic stress. DISCUSSION:This study will determine the feasibility of delivering six sessions of cognitive behavioural therapy for individuals with current psychotic symptoms who also experience clinically significant levels of depersonalisation. The results will provide information to inform a larger randomised trial to assess intervention efficacy. TRIAL REGISTRATION:ClinicalTrials.gov NCT02427542.

Dataset Information

App to support Recovery in Early Intervention Services (ARIES) study: protocol of a feasibility randomised controlled trial of a self-management Smartphone application for psychosis.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

App to support Recovery in Early Intervention Services (ARIES) study: protocol of a feasibility randomised controlled trial of a self-management Smartphone application for psychosis.

Similar Datasets

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