The effect of the Yara smartphone application on anxiety, sleep quality, and suicidal thoughts in patients with major depressive disorder in Iran: a randomized controlled trial

Depression is one of the most common mental disorders worldwide [1]. More than 350 million people suffer from this disorder worldwide, and it is predicted to rank highest in the disease burden by 2030 [1‐3]. The prevalence of depression is 42.59% of the general population in Iran [4]. Depression increasingly impacts the global disease burden [5], so people with severe depression report serious problems in all aspects of their lives, including occupational, home, and social activities [6]. Depression leads to social and psychological issues such as anxiety, fear of being in a group [7], social deprivation [8], increased mortality [9], feelings of worthlessness [10], suicide [1], sleep disorders, and high direct and social costs [11, 12]. Depression is one of the most expensive disorders to treat and increases the tendency towards physical illnesses and suicide, which causes youth mortality [13].

Pharmacotherapy has been approved as a standard treatment method for depression. However, fear of its side effects, such as dependence, causes patients to avoid medications [1]. On the other hand, non-pharmacological interventions are usually clinical or hospital-based and require weekly or monthly visits. Moreover, time constraints, transportation problems, and associated costs make it difficult for 70% of patients to attend regular psychotherapy sessions [14]. Meanwhile, depressed patients with physical problems are often socially isolated and stay home. Therefore, any action used at home for patients can lead to tremendous success rather than hospital-based methods [1, 15, 16]. Nowadays, smartphones and related applications offer a wide range of services that can benefit patients with mood disorders. One of these applications is mobile health applications that increase access to care, reduce stress, improve diagnosis, and expand the treatment of various psychiatric disorders [17]. These health applications reduce appointment waiting time and the need for face-to-face visits with a physician. The use of health applications is even more cost-effective than other methods [18]. However, only a few of these applications have focused on supporting individuals with mental health problems such as stress, anxiety, depression, post-traumatic stress disorder, and obsessive-compulsive disorder [19]. Given the widespread access to smartphones and their potential for self-management, it seems that the use of smartphones in patients with depression is becoming more important than ever before [20]. Regarding the prevalence and pandemic of COVID-19 as a highly contagious disease, remote nursing counseling and education through smartphone applications can be useful and reduce the patients' referral to hospitals, reducing the risk of exposure to this deadly disease [9]. In 2018, Deady et al. investigated the effect of the "HeadGear" smartphone application on treating depression symptoms for three months in Australia and found a positive effect on reducing the symptoms of patients with depression [6]. In another study in the United States in 2018, Pratap et al. investigated the effect of smartphone applications on depressed patients for six months and observed no positive impact on depression symptoms. They suggested further studies to comprehensively examine smartphone applications for patients with different cultures [21]. Therefore, there is no consensus about using smartphone applications to reduce depression symptoms, and further investigation is still needed. Given the high prevalence of depression in Iran [4, 22] and the world [23], the disabling and numerous symptoms of this disorder [4], and the easy access of depressed patients to smartphones, the research team designed a smartphone application (Yara) to investigate its impact on anxiety, sleep quality, and suicidal thoughts in patients with MDD. This study aimed to determine the effect of new developed YARA smartphone application on anxiety, sleep quality, and suicidal thoughts in patients with MDD. The research hypothesis was that using the Yara smartphone application would improve anxiety, sleep quality, and suicidal thoughts in patients with MDD.

There was no sample attrition in this study, so 64 patients were included in the analysis. The data distribution was examined using the Kolmogorov-Smirnov test, and the data distribution was normal except for suicidal thoughts. The independent samples t-test results showed no significant difference in demographic variables between the two groups (Table 1).

There was no statistically significant difference in the mean scores of anxiety and its dimensions between the two groups before the intervention (p ≥ .05). However, this difference was shown to be statistically significant after the intervention (p < .001) (Table 2).

There was a statistically significant difference between the baseline and the post-intervention mean scores of anxiety in the intervention group (p < .05). However, this difference was not statistically significant in the control group (p = .084) (Table 3).

There was no statistically significant difference in the mean score of sleep quality between the two groups before the intervention (p ≥ .05). However, this difference in the mean score of sleep quality was statistically significant after the intervention (p < .05). There was a statistically significant difference between the baseline and the post-intervention mean score of sleep quality in the intervention group (p < .05). At the same time, this difference was not statistically significant in the control group (p = .942) (Table 4).

According to the results of the Mann-Whitney U test, there was no statistically significant difference in the mean score of suicidal thoughts and its dimensions between the intervention and control groups before the intervention (p ≥ .05). Moreover, there was no significant statistically significant difference in the mean score of suicidal thoughts and its dimensions between the two groups after the intervention (p ≥ .05) (Table 5).

According to the Wilcoxon signed-rank test, there was no statistically significant difference between the baseline and the post-intervention mean score of suicidal thoughts and its dimensions within the intervention group (p ≥ .05). Similarly, the same difference was not statistically significant within the control group (p ≥ .05) (Table 6).

The findings showed that the intervention and control groups had no statistically significant difference in demographic variables, including age, gender, marital status, education level, and Job-status that could affect the study results. Therefore, a significant difference between the baseline and post-intervention means anxiety scores in the intervention group were due to the Yara application's positive effect.

The results revealed that using the Yara application effectively reduced anxiety in patients with MDD. It should be noted that utilizing the Yara smartphone application was effective in reducing psychological problems such as anxiety because this application was developed based on the management of attention, relaxation, and self-control. Yoga and exercise videos are available in the application, which can help patients reduce stress. Moreover, using soothing instrumental music (such as sounds and melodies from nature) in this application can help reduce anxiety and promote restful sleep among patients [30]. When patients use the application, they become more aware of their surroundings and events, feel more in control, and can better control their thoughts, actions, and emotions. On the other hand, negative emotions can always disturb the mental state of patients and cause them to experience anxiety with constant thoughts about it [31]. This application can reduce anxiety using its emotion-control feature and the consideration of the current situation. In Iran, Borjalilu et al. (2016) also found that mobile phone applications can effectively reduce anxiety [32]. Among studies conducted in this area, Deady et al. (2020) reached similar results and found that smartphone applications can reduce depression symptoms and successive incidents of depression among Australian employees [33]. In the U.S.A., Longyear and Kushlev (2021) reviewed 18 clinical trials in a systematic review and reported that smartphone applications can reduce anxiety, depression, and stress [34].

The results indicated that using the Yara smartphone application had no significant effect on reducing suicidal thoughts in patients with MDD. O'Toole et al. (2019) also found that using a smartphone application did not significantly reduce depression and suicidal thoughts in patients [35]. Tighe et al. (2017) observed a significant decrease in depression symptoms after using the Ibobbly application but no significant reduction in suicidal thoughts or ideation [36]. Denneson et al. (2019) demonstrated that using smartphone applications alone is ineffective in alleviating depression symptoms and suicidal thoughts, but they can reduce depression symptoms and suicidal ideation severity if mediated through coping self-efficacy [37]. One of the most significant challenges to suicide prevention is that many known risk factors that predict changes in suicidal ideation over months/years (e.g., hopelessness) cannot be prevented over hours/days. This highlights a gap in our ability to prevent suicide in the short term [38]. Another plausible reason for the lack of effect of the smartphone application on suicidal thoughts can be the non-compliance of these patients with the interventions related to suicide prevention in the application. In the meta-analysis study conducted in Australia, Witt et al. (2017) reported that compliance with interventions related to suicidal thoughts was low in most studies [39]. Adherence to interventions related to suicidal thoughts was also poor during the long-term follow-up period. Over half (64%) of the participants did not access the intervention during the one-month follow-up period in the previous study[40]. This suggests that using digital innovations, including smartphone applications, may not be sufficient to sustain these interventions in the long term. It seems that the Yara application did not successfully improve suicidal thoughts in three months, so it is recommended to consider a longer time in employing suicide prevention applications in the future. Additionally, some studies have discussed the positive role of some applications in causing depression symptoms. Yang et al. (2010) reported that mobile applications and games can induce risky behaviors [41]. Khasawneh et al. (2020) also found that mobile phones, applications, and social media can induce suicidal thoughts [42]. Despite the above, numerous studies have approved the positive effect of smartphone applications in this regard [43, 44]. In a systematic review, Malakouti et al. (2020) mentioned the conflicting results regarding the effect of smartphone applications on suicidal thoughts and recommended conducting further studies in this regard [45].

The results indicated that the use of mobile phone applications had a positive effect on the sleep quality of patients and improved their sleep. The Yara application increased patients' awareness and knowledge by providing scientific content on sleep and the consequences of sleep disorders. It also helped them improve the quality of their sleep by offering physical exercise, soothing music tracks, and yoga. In line with our study results, in the U.S.A., Choi et al. (2018)found that some applications can effectively improve sleep quality due to their predetermined quality criteria, content, and performance for sleep management [46]. In a study conducted in Germany, Fietze (2016) also concluded that mobile applications can help individuals increase their awareness of sleep health and identify people with poor sleep quality compared to those who suffer more from paradoxical insomnia [47]. Karsaneh et al. (2022) conducted a review study in Jordan and concluded that existing applications for self-management of sleep disorders or improving sleep quality may be valuable, but they must be developed in quality and content [48]. Many people rely on sleeping pills as the most suitable solution for getting rid of sleep disorders. However, long-term use of such drugs has led to other problems and resulted in chronic insomnia. Clinical psychologists use various forms of psychotherapy to help individuals improve and maintain their sleep patterns [49]. It should be noted that many individuals choose natural treatments for depression and avoid pharmacotherapy. Coping with depression naturally can be effective if proper nutrition and better sleep are accompanied. The Yara application combines various techniques such as yoga, motivational speeches, and soothing music tracks to help users overcome depression naturally.

One of the limitations of this study was the simultaneous occurrence of the COVID-19 pandemic and patients' fear of catching it during the briefing session. This problem was addressed by providing personal protective equipment such as masks, disposable gloves, disinfectants, and face shields. Another limitation of the study was the possibility of using other measures to reduce the symptoms of depression by patients that were out of the researcher's hands. Another study limitation was the lack of long-term patient follow-up after the intervention period. This application is specially made for Iranian culture and the Persian language, so it may not apply to the general population. Therefore, the necessary changes for its internationalization and validation should be done. This study was conducted in a limited environment with a small sample size, which may pose challenges in generalizing the results. Therefore, it is recommended to conduct studies with larger sample sizes in diverse environments to examine the effects of intervention better. Additionally, it is suggested to investigate the effect of the Yara smartphone application on other symptoms of depression.

The Yara application is a suitable solution for improving anxiety and sleep quality in patients with MDD. Digital technologies allow smartphones to be transformed into devices that can provide cost-effective mental health services and reduce users' stress. Using smartphone applications was ineffective in reducing suicidal ideation in this study. Many known risk factors that predict suicidal thoughts over months/years (e.g., hopelessness) cannot be prevented over hours/days. It is recommended to consider a longer time in employing suicide prevention applications in the future.