Behavioral Activation Mobile App to Motivate Smokers to Quit: Feasibility and Pilot Randomized Controlled Trial.

BACKGROUND: Behavioral activation (BA) is an evidence-based treatment for depression that fosters engagement in values-based activities to increase access to positive reinforcement. Depressed mood has been shown to hinder smoking cessation. OBJECTIVE: This study determined the feasibility and preliminary efficacy of a mobile app to motivate smokers to quit by using BA and integrating motivational messages to quit smoking. METHODS: Adult smokers (N=56; mean age 34.5, SD 9.52 years) who were not ready to quit smoking within 30 days were recruited from advertisements and randomized to either 8 weeks of the BA app (set 2 values-based activities per week+motivational messages+feedback on changes in smoking, mood, and values-based activities) or the control group (no app; received resources for quitting smoking). All participants completed the baseline and end-of-treatment web-based questionnaires. Controls also completed weekly web-based assessments, and BA app participants completed assessments through the app. RESULTS: There were no dropouts and only 2 participants in each condition did not complete the end-of-treatment questionnaire. The results demonstrated that it is feasible to recruit smokers who are unmotivated to quit into a smoking cessation induction trial: 86% (57/66) of eligible participants were randomized (BA app: n=27; control: n=29). Participants reported high levels of satisfaction: 80% (20/25) of participants said they would recommend the BA app, there were moderate-to-high scores on the Mobile App Rating Scale, and 88% (22/25) of participants rated the app 3 stars or higher (out of 5). There were high levels of BA app engagement: 96% (26/27) of participants planned activities, and 67% (18/27) of participants planned 7 or more activities. High engagement was found even among those who were at the highest risk for continued smoking (low motivation to quit, low confidence to quit, and high negative affect). The results provided support for the hypothesized relationships between BA constructs: greater pleasant activity completion was associated with greater positive affect (b=0.37, SE 0.21; 95% CI -0.05 to 0.79; P=.08), and greater positive affect tended to predict fewer cigarettes smoked the next day (b=-0.19, SE 0.10; 95% CI -0.39 to 0.01; P=.06). Additionally, a greater number of activities planned was associated with lower negative affect (b=-0.26, SE 0.15; 95% CI -0.55 to 0.04; P=.09). Overall, 16% (4/25) of BA app participants set a quit date versus 4% (1/27) among controls, and there were promising (but not significant) trends for motivation and confidence to quit. CONCLUSIONS: The findings suggest that a mobile app intervention can be made appealing to smokers who are unmotivated to quit by focusing on aspects most important to them, such as mood management. This theory-based intervention has shown some initial support for the underlying theoretical constructs, and further efficacy testing is warranted in a fully powered trial.

Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial.

BACKGROUND: The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. METHODS: A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. RESULTS: The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60-80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. CONCLUSION: The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. TRIAL REGISTRATION: ISCTRN ISRCTN13404264. Registered on 10 October 2018.

Acceptability of reducing sedentariness using a mobile-phone application based on 'if then' plans for people with psychosis: A focus-group study conducted in North West England, UK.

OBJECTIVE: To understand the acceptability of (a) reducing sedentary-behaviour in people with psychosis using 'if-then' plans and (b) the proposed app content. DESIGN: Qualitative acceptability study. METHOD: Three structured focus-groups and an interview were conducted with eight participants who had experience of a psychotic episode. They discussed sedentary-behaviour, being more active, critical situations in which they may be tempted to be sedentary and solutions to these (the if-then plans), and a mock-up of the mobile application. The Theoretical Framework of Acceptability (TFA) was used to analyse qualitatively the transcripts. RESULTS: All TFA constructs were coded in each of the transcripts. The idea of reducing sedentary-behaviour was acceptable to people with psychosis, participants knew the importance of being more active, however it is not always their main priority. Likewise, the proposed content of the app was found to be acceptable, with participants already using some of the proposed solutions. CONCLUSION: This was the first study to use the TFA framework to assess the acceptability of an app that uses critical situations and solutions ('if-then plans') to help reduce sedentary behaviour for people with psychosis. In this sample (male, English speaking mainly white people), participants understood the benefits of being more active. However, reducing sedentary-behaviour is not the main priority of this population and being sedentary has benefits when their mental-health is bad.

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone-based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial. OBJECTIVE: The aim of this trial is to determine the effectiveness and cost-effectiveness of this intervention for reducing cardiovascular risk in people with type 2 diabetes by comparing it with usual care. METHODS: The trial will be a 12-month, multicenter, individually randomized controlled trial in primary care and will recruit adults (aged ≥35 years) with type 2 diabetes in England. Consenting participants will be randomized to receive short SMS text messages intended to affect a change in medication adherence 3 to 4 times per week in addition to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when it is added to usual care. The primary clinical outcome will be a composite cardiovascular risk measure. Data including patient-reported measures will be collected at baseline, at 13 and 26 weeks, and at the end of the 12-month follow-up period. With 958 participants (479 in each group), the trial is powered at 92.5% to detect a 4-percentage point difference in cardiovascular risk. The analysis will follow a prespecified plan. A nested quantitative and qualitative process analysis will be used to examine the putative mechanisms of behavior change and wider contextual influences. A health economic analysis will be used to assess the cost-effectiveness of the intervention. RESULTS: The trial has completed the recruitment phase and is in the follow-up phase. The publication of results is anticipated in 2024. CONCLUSIONS: This trial will provide evidence regarding the effectiveness and cost-effectiveness of this intervention for people with type 2 diabetes. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15952379; https://www.isrctn.com/ISRCTN15952379. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32918.

Understanding acceptability in the context of text messages to encourage medication adherence in people with type 2 diabetes.

BACKGROUND: Acceptability is recognised as a key concept in the development of health interventions, but there has been a lack of consensus about how acceptability should be conceptualised. The theoretical framework of acceptability (TFA) provides a potential tool for understanding acceptability. It has been proposed that acceptability measured before use of an intervention (anticipated acceptability) may differ from measures taken during and after use (experienced acceptability), but thus far this distinction has not been tested for a specific intervention. This paper 1) directly compares ratings of anticipated and experienced acceptability of a text message-based intervention, 2) explores the applicability of the TFA in a technology-based intervention, and 3) uses these findings to inform suggestions for measuring acceptability over the lifespan of technology-based health interventions. METHODS: Data were obtained from a quantitative online survey assessing anticipated acceptability of the proposed text messages (n = 59) and a 12-week proof-of-concept mixed methods study assessing experienced acceptability while receiving the text messages (n = 48). Both quantitative ratings by return text message, and qualitative data from participant interviews were collected during the proof-of-concept study. RESULTS: The quantitative analysis showed anticipated and experienced acceptability were significantly positively correlated (rs > .4). The qualitative analysis identified four of the seven constructs of the TFA as themes (burden, intervention coherence, affective attitude and perceived effectiveness). An additional two themes were identified as having an important impact on the TFA constructs (perceptions of appropriateness and participants' role). Three suggestions are given related to the importance of appropriateness, what may affect ratings of acceptability and what to consider when measuring acceptability. CONCLUSIONS: The high correlation between anticipated and experienced acceptability was a surprising finding and could indicate that, in some cases, acceptability of an intervention can be gauged adequately from an anticipated acceptability study, prior to an expensive pilot or feasibility study. Directly exploring perceptions of appropriateness and understanding whether the acceptability described by participants is related to the intervention or the research - and is for themselves or others - is important in interpreting the results and using them to further develop interventions and predict future use.