No abstract

BACKGROUND Lack of physical activity (PA) is a common issue with detrimental consequences for the health of people with severe mental illness (SMI). Existing PA interventions show suboptimal effects because they require substantial cognitive skills, including goal setting and writing, while cognitive deficits are common in this population. To bolster the effectiveness of PA interventions, self-control training (SCT), in which users practice the ability to override unwanted thoughts and behaviors, can be used as an addition. Recent research has demonstrated initial effectiveness of a mobile self-control training app, but this has not been studied in psychiatric clinical practice. OBJECTIVE The aim of this study is to evaluate to what extent adding a mobile self-control app designed for and with people with SMI to an existing PA intervention increases physical activity and self-control levels. METHODS A mixed-methods approach incorporating two single-case experimental designs (SCED) and qualitative interviews is used to evaluate and optimize SCT. 12 participants with SMI will be recruited from two organizations that offer inpatient care to people with SMI. In each experiment 6 inpatients will be included. SCED I is a concurrent multiple-baseline design across participants, which explores initial effectiveness and optimal intervention duration. Using accelerometry and experience sampling questionnaires, participants’ physical activity and self-control will be monitored for at least 5 days of baseline. This is followed by sequential introduction of Google Fit, a PA intervention for 7 days, and the addition of SCIPP: the Self Control Intervention aPP, used for 28 days. SCED II is an introduction/withdrawal design, in which optimized self-control training will be introduced and withdrawn to validate findings from SCED I. In both experiments, daily average of total activity counts per hour and state level of self-control will serve as the primary and secondary outcome measures. Data will be analyzed using visual analysis and piecewise linear regression models. RESULTS The study has been designated as not subject to the Dutch Medical Research Involving Human Subjects Act by the Medical Research Ethical Committee Oost Nederland and has been approved by the University of Twente Ethical Committee Behavioral, Management and Social Sciences. Recruitment for the study has started January 2022 and we expect to publish the results early 2023. CONCLUSIONS The mobile self-control training app is expected to be feasible and effective. It is self-paced, scalable, and can increase patient motivation, making it a suitable intervention to target people with SMI. SCED is a relatively novel yet very promising method for gaining insight into if and how mobile apps work, which can handle heterogenous samples and makes it possible to involve the diverse population of people with SMI without having to include a large number of participants. CLINICALTRIAL Central Committee on Research involving Human Subjects (CCMO Toetsingonline) NL79450.091.21.

Background Lack of physical activity is a common issue with detrimental consequences for the health of people with severe mental illness (SMI). Existing physical activity interventions show suboptimal effects as they require substantial cognitive skills, including goal setting and writing, whereas cognitive deficits are common in this population. To bolster the effectiveness of physical activity interventions, self-control training (SCT), in which users practice the ability to override unwanted thoughts and behaviors, can be used in addition. Recent research has demonstrated the initial effectiveness of a mobile SCT app, but this has not been studied in psychiatric clinical practice. Objective This study aims to evaluate to what extent adding a mobile SCT app designed for and with people with SMI to a mobile lifestyle intervention aimed at increasing physical activity increases physical activity and self-control levels. Methods A mixed methods approach incorporating 2 single-case experimental designs (SCEDs) and qualitative interviews was used to evaluate and optimize SCT. Overall, 12 participants with SMI will be recruited from 2 organizations offering outpatient and inpatient care to people with SMI. Each experiment will include 6 patients. SCED I is a concurrent multiple-baseline design across participants that explores initial effectiveness and optimal intervention duration. Using accelerometry and experience sampling questionnaires, participants’ physical activity and self-control will be monitored for ≥5 days from baseline, followed by the sequential introduction of Google Fit, the physical activity intervention, for 7 days and the addition of SCIPP: Self-Control Intervention App for 28 days. SCED II is an introduction/withdrawal design in which optimized SCT will be introduced and withdrawn to validate the findings from SCED I. In both experiments, the daily average of total activity counts per hour and the state level of self-control will serve as the primary and secondary outcome measures. Data will be analyzed using visual analysis and piecewise linear regression models. Results The study was designated as not subject to the Dutch Medical Research Involving Human Subjects Act by the Medical Research Ethical Committee Oost-Nederland and approved by the Ethics Committee/domain Humanities and Social Sciences of the Faculty of Behavioural, Management, and Social Sciences at the University of Twente. Participant recruitment started in January 2022, and we expect to publish the results in early 2023. Conclusions The mobile SCT app is expected to be feasible and effective. It is self-paced and scalable and can increase patient motivation, making it a suitable intervention for people with SMI. SCED is a relatively novel yet promising method for gaining insights into whether and how mobile apps work that can handle heterogeneous samples and makes it possible to involve a diverse population with SMI without having to include a large number of participants. International Registered Report Identifier (IRRID) PRR1-10.2196/37727