The usability, acceptability, and satisfaction of a digital mental health tool for patients with breast and prostate cancer

The impact and use of digital health tools vary considerably among individuals dealing with somatic illnesses, such as cancer. This variability can be attributed to several factors, such as sociodemographic characteristics, baseline mental health, perception of the intervention’s usefulness, ease of use, and early engagement with the system. In this thesis, we aimed to examine the influence and interaction among these indicators on the usability, acceptability, satisfaction, and clinical effectiveness of a digital health tool in individuals with breast and prostate cancer. All studies were based on data from the NEVERMIND trial, a clinical randomized controlled trial that included patients with five different somatic illnesses. Our study included 255 participants (at baseline) who were diagnosed with breast or prostate cancer. Half of the participants (n=129) were allocated to the NEVERMIND system, whereas the other half (n=125) were allocated to the treatment as usual (control) group. Those in the NEVERMIND system group were involved in the use of the NEVERMIND digital health tool, comprising a mobile app and sensorized shirt (shirt), over a 12-week period. Data from baseline assessments and follow-ups at four and 12 weeks were used. The aim was to assess the usability, acceptability, and satisfaction of the NEVERMIND system, as well as the factors associated with these dimensions. This Ph.D. project also examined how usability and acceptability impacted the clinical effectiveness of the NEVERMIND system on depressive and stress symptoms. Study I. We investigated the association between baseline sociodemographic characteristics and usability assessed at four and 12 weeks of using the NEVERMIND system among 108 patients with breast and prostate cancer who received and used the system. The NEVERMIND system had good usability according to the usability questionnaires. Higher favourability of the mobile app was observed among women (breast cancer patients) compared to men (prostate cancer patients); however, men had significantly higher use of the overall system. Study II. The relationships between sex, education, baseline depressive and stress symptoms, perceived ease of use, perceived usefulness, and system usage at various stages were examined using Bayesian Structural Equation Modelling in a path analysis of 129 patients with breast and prostate cancer. Higher perceived usefulness and initial usage were associated with a higher level of usage at 12 weeks. The results indicated that a better understanding of the system’s benefits and early engagement were key drivers of its sustained use and clinical effectiveness in improving mental health outcomes. Study III. In a sample of 255 patients with breast and prostate cancer, we examined the relationship between the clinical effectiveness, usability, and acceptability of the NEVERMIND system when treating depressive and stress symptoms in patients with breast and prostate cancer. The results showed that patients in the NEVERMIND group had a greater reduction in depressive symptoms than those in the control group at the 12-week follow-up. The findings also showed that users who utilized the system for more than six weeks experienced a statistically significant decrease in both depressive symptoms and stress symptoms compared to those who used it for less than two weeks. Study IV. This study looked at the overall satisfaction of users (68 with breast cancer and 39 with prostate cancer) with the NEVERMIND system. Satisfaction was measured at four and 12 weeks using a one-item questionnaire with two open-ended follow-up questions about user experiences. An inductive and deductive thematic analysis was conducted by using the NEVERMIND system’s components as a sensitizing concept which was then refined and interpreted through the lens of Information Systems (IS) success model. The findings show that 68.24% of users rated the system as good or excellent at four weeks, with a slight decrease to 65.42% at 12 weeks. Three themes emerged from the thematic analysis: (1) Fostering Personal Agency and Motivation, (2) Engagement and Interaction Experiences, and (3) Content Quality and Relevance. Gender differences emerged in the prioritization of emotional support among female users and self-awareness among male users. The satisfaction and challenges faced by users underscore the importance of a user-centric approach that focuses on holistic well-being, user engagement, personalized content, and technical stability. This study also contributes to the broader literature by utilizing IS success model as a framework for interpreting user satisfaction. Conclusions. Higher levels of usability, acceptability, and satisfaction in the NEVERMIND system may contribute to improving the mental health outcomes of patients with breast and prostate cancer, both independently from each other, and even more so when high levels of engagement, acceptance, use, and satisfaction coexist. They emphasize the importance of perceived usefulness, initial engagement, and user-centric design in different components of the NEVERMIND system and confirms the multidimensionality of successful digital health tools implementation. Moreover, the notable differences in usability and preference between genders indicate that tailored and personalized strategies might serve as effective means to address diverse user needs. Taken together, these insights strengthen scientific evidence for healthcare experts and digital health innovators and developers, guiding them towards creating and designing digital health tools through user-centric and multi-domain approaches

A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions

Background Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions. The study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions. Trial registration DRKS00013391. Registered 23 November 2017

The NEVERMIND e-health system in the treatment of depressive symptoms among patients with severe somatic conditions: A multicentre, pragmatic randomised controlled trial

Background This study assessed the effectiveness of the NEVERMIND e-health system, consisting of a smart shirt and a mobile application with lifestyle behavioural advice, mindfulness-based therapy, and cognitive behavioural therapy, in reducing depressive symptoms among patients diagnosed with severe somatic conditions. Our hypothesis was that the system would significantly decrease the level of depressive symptoms in the intervention group compared to the control group. Methods This pragmatic, randomised controlled trial included 425 patients diagnosed with myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants were recruited from hospitals in Turin and Pisa (Italy), and Lisbon (Portugal), and were randomly assigned to either the NEVERMIND intervention or to the control group. Clinical interviews and structured questionnaires were administered at baseline, 12 weeks, and 24 weeks. The primary outcome was depressive symptoms at 12 weeks measured by the Beck Depression Inventory II (BDI-II). Intention-to-treat analyses included 425 participants, while the per-protocol analyses included 333 participants. This trial is registered in the German Clinical Trials Register, DRKS00013391. Findings Patients were recruited between Dec 4, 2017, and Dec 31, 2019, with 213 assigned to the intervention and 212 to the control group. The sample had a mean age of 59·41 years (SD=10·70), with 44·24% women. Those who used the NEVERMIND system had statistically significant lower depressive symptoms at the 12-week follow-up (mean difference=-3·03, p<0·001; 95% CI -4·45 to -1·62) compared with controls, with a clinically relevant effect size (Cohen's d=0·39). Interpretation The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions. Funding The NEVERMIND project received funding from the European Union's Horizon 2020 Research and Innovation Programme under grant agreement No. 689691

Sociodemographic Characteristics Associated With an eHealth System Designed to Reduce Depressive Symptoms Among Patients With Breast or Prostate Cancer: Prospective Study

BackgroundeHealth interventions have become a topic of interest in the field of mental health owing to their increased coordination and integration of different elements of care, in treating and preventing mental ill health in patients with somatic illnesses. However, poor usability, learnability, and user engagement might affect the effectiveness of an eHealth intervention. Identifying different sociodemographic characteristics that might be associated with higher perceived usability can help improve the usability of eHealth interventions. ObjectiveThis study aimed to identify the sociodemographic characteristics that might be associated with the perceived usability of the NEVERMIND (Neurobehavioural Predictive and Personalised Modelling of Depressive Symptoms During Primary Somatic Diseases) eHealth system, comprising a mobile app and a sensorized shirt, in reducing comorbid depressive symptoms in patients with breast or prostate cancer. MethodsThe study included a total of 129 patients diagnosed with breast (n=80, 62%) or prostate (n=49, 38%) cancer, who received a fully automated mobile app and sensorized shirt (NEVERMIND system). Sociodemographic data on age, sex, marital status, education level, and employment status were collected at baseline. Usability outcomes included the System Usability Scale (SUS), a subjective measure that covers different aspects of system usability; the user version of the Mobile App Rating Scale (uMARS), a user experience questionnaire; and a usage index, an indicator calculated from the number of days patients used the NEVERMIND system during the study period. ResultsThe analysis was based on 108 patients (n=68, 63%, patients with breast cancer and n=40, 37%, patients with prostate cancer) who used the NEVERMIND system for an average of 12 weeks and completed the study. The overall mean SUS score at 12 weeks was 73.4 (SD 12.5), which indicates that the NEVERMIND system has good usability, with no statistical differences among different sociodemographic characteristics. The global uMARS score was 3.8 (SD 0.3), and women rated the app higher than men (β=.16; P=.03, 95% CI 0.02-0.3), after adjusting for other covariates. No other sociodemographic characteristics were associated with higher uMARS scores. There was a statistical difference in the use of the NEVERMIND system between women and men. Women had significantly lower use (β=–0.13; P=.04, 95% CI −0.25 to −0.01), after adjusting for other covariates. ConclusionsThe findings suggest that the NEVERMIND system has good usability according to the SUS and uMARS scores. There was a higher favorability of mobile apps among women than among men. However, men had significantly higher use of the NEVERMIND system. Despite the small sample size and low variability, there is an indication that the NEVERMIND system does not suffer from the digital divide, where certain sociodemographic characteristics are more associated with higher usability. Trial RegistrationGerman Clinical Trials Register RKS00013391; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS0001339

Predictors of the Use of a Mental Health–Focused eHealth System in Patients With Breast and Prostate Cancer: Bayesian Structural Equation Modeling Analysis of a Prospective Study

BackgroundeHealth systems have been increasingly used to manage depressive symptoms in patients with somatic illnesses. However, understanding the factors that drive their use, particularly among patients with breast and prostate cancer, remains a critical area of research. ObjectiveThis study aimed to determine the factors influencing use of the NEVERMIND eHealth system among patients with breast and prostate cancer over 12 weeks, with a focus on the Technology Acceptance Model. MethodsData from the NEVERMIND trial, which included 129 patients with breast and prostate cancer, were retrieved. At baseline, participants completed questionnaires detailing demographic data and measuring depressive and stress symptoms using the Beck Depression Inventory–II and the Depression, Anxiety, and Stress Scale–21, respectively. Over a 12-week period, patients engaged with the NEVERMIND system, with follow-up questionnaires administered at 4 weeks and after 12 weeks assessing the system’s perceived ease of use and usefulness. Use log data were collected at the 2- and 12-week marks. The relationships among sex, education, baseline depressive and stress symptoms, perceived ease of use, perceived usefulness (PU), and system use at various stages were examined using Bayesian structural equation modeling in a path analysis, a technique that differs from traditional frequentist methods. ResultsThe path analysis was conducted among 100 patients with breast and prostate cancer, with 66% (n=66) being female and 81% (n=81) having a college education. Patients reported good mental health scores, with low levels of depression and stress at baseline. System use was approximately 6 days in the initial 2 weeks and 45 days over the 12-week study period. The results revealed that PU was the strongest predictor of system use at 12 weeks (βuse at 12 weeks is predicted by PU at 12 weeks=.384), whereas system use at 2 weeks moderately predicted system use at 12 weeks (βuse at 12 weeks is predicted by use at 2 weeks=.239). Notably, there were uncertain associations between baseline variables (education, sex, and mental health symptoms) and system use at 2 weeks, indicating a need for better predictors for early system use. ConclusionsThis study underscores the importance of PU and early engagement in patient engagement with eHealth systems such as NEVERMIND. This suggests that, in general eHealth implementations, caregivers should educate patients about the benefits and functionalities of such systems, thus enhancing their understanding of potential health impacts. Concentrating resources on promoting early engagement is also essential given its influence on sustained use. Further research is necessary to clarify the remaining uncertainties, enabling us to refine our strategies and maximize the benefits of eHealth systems in health care settings

A Naturalistic, European Multi-Center Clinical Study of Electrodermal Reactivity and Suicide Risk Among Patients With Depression

Background: Electrodermal hyporeactivity has been proposed as a marker of suicidal risk. The EUDOR-A study investigated the prevalence of electrodermal hyporeactivity among patients with depression and its association with attempted and completed suicide. Methods: Between August 2014 and March 2016, 1,573 in- and outpatients with a primary diagnosis of depression (active or remission phase) were recruited at 15 European psychiatric centers. Each patient was followed-up for 1 year. Electrodermal activity was assessed at baseline with the ElectroDermal Orienting Reactivity Test. Data on the sociodemographic characteristics, clinical diagnoses, and treatment of the subjects were also collected. The severity of the depressive symptoms was assessed through the Montgomery-Asberg Depression Rating Scale. Information regarding number, time, and method of suicide attempts was gathered at baseline and at the end of the 1-year follow-up. The same data were collected in case of completed suicide. Results: Hyporeactive patients were shown to be significantly more at risk of suicide attempt compared to reactive patients, both at baseline and follow-up. A sensitivity of 29.86% and a positive predictive value (PPV) of 46.77% were found for attempted suicide at baseline, while a sensitivity of 35.36% and a PPV of 8.92% were found for attempted suicide at follow-up. The sensitivity and PPV for completed suicide were 25.00 and 0.61%, respectively. However, when controlled for suicide attempt at baseline, the association between hyporeactivity and follow-up suicide attempt was no longer significant. The low number of completed suicides did not allow any analysis