A Mobile Self-control Training App to Improve Self-control and Physical Activity in People With Severe Mental Illness: Protocol for 2 Single-Case Experimental Designs (Preprint)

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 SCED II is an introduction/withdrawal design, in which optimized self-control training will be introduced and withdrawn to validate findings from SCED I. In both experiments, daily average of total activity counts per hour and state level of self-control will serve as the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.

Best-practices for co-design processes involving people with severe mental illness for eMental health interventions: a qualitative multi-method approach

“…The respondents were recruited through convenience sampling within the networks of the development team of a self-control training application for the SMI population (Dekkers et al 2022). In addition, the opportunity for snowball sampling was encouraged as the respondents were asked to further distribute the survey within their network.…”

“…The interviews took place straight after the final workshops. In total, five workshops were held in June and July of 2021 at two different facilities (Dekkers et al 2022). Each workshop lasted around 90 minutes.…”

“…Globally, around 1% of the population has a severe mental illness (SMI) such as bipolar disorder, schizophrenia and major depressive disorder (Dekkers et al 2022;Naslund et al 2015a). In order to be classified as SMI, these diagnoses must have persisted for at least two years, during which care was required from various coordinated disciplines to treat disability in functioning (Delespaul and de consensusgroep EPA 2013;Wiersma 2006).…”