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Received: 3 October 2017 Revised: 14 November 2017 Accepted: 17 December 2017

DOI: 10.1111/eip.12540

BRIEF REPORT

Feasibility and preliminary efficacy of a smartphone


application intervention for subthreshold depression
Kana Takahashi | Koki Takada | Kazuki Hirao

Department of Occupational Therapy, Kibi


International University, Takahashi, Japan Aim: We developed a motion picture-reproducing smartphone application (app) designed to
Correspondence improve self-confidence in individuals with subthreshold depression (StD) and examined the
Kazuki Hirao, Department of Occupational feasibility and preliminary efficacy of an app intervention for individuals with StD.
Therapy, Kibi International University, 8 Iga-
Methods: We conducted an open-label, single-arm pre-post study of 22 young adults with
machi Takahashi, Okayama 716-8508, Japan.
Email: hirao-k@kiui.ac.jp StD. Our intervention involved app usage for at least 70 min/wk for 5 weeks. The primary out-
Funding information come measure was the adherence rate. Secondary outcome measures were safety and Center
Japan Society for the Promotion of Science, for Epidemiologic Studies Depression Scale (CES-D) scores.
Grant/Award number: JP16K16583 Results: No participants dropped out during the study. The adherence rate was 50%. The mean
time of app use over 5 weeks was 124.23  81.94 min/wk. No adverse events were reported.
The CES-D scores were significantly improved at 5 weeks post-intervention.
Conclusions: Although this app intervention has the potential to reduce depressive symptoms,
the app needs to be improved to increase adherence rates.

KEYWORDS

application, eHealth, mHealth, smartphone, subthreshold depression

1 | I N T RO D UC T I O N individuals with StD in finding treatment options. The use of smart-


phones for sharing helpful mental health resources may also aid
Major depressive disorder (MDD) is one of the most common mental underprivileged individuals with StD and bridge the gap due to the
health problems. The 12-month prevalence of MDD is estimated to limited availability of mental health services. In this context, we
be 5.1% (Kessler et al., 2015), with an annual incidence rate of 3% developed a motion picture-reproducing app (SPSRS) designed to
(Ferrari et al., 2013). This implies that approximately 60% of depres- improve self-confidence in individuals suffering from StD (Takahashi
sion cases are new, underscoring the importance of preventing et al., 2017), based on evidence from subliminal studies (Aoyama
depression. Although focusing on depression is important, the exis- et al., 2017; Van den Bussche, Van den Noortgate, & Rey-
tence of subthreshold depression (StD) cannot be overlooked nvoet, 2009).
(Furukawa et al., 2012). StD can be defined as a severity cut point on This study examined the feasibility and preliminary efficacy of an
a self-administered depression measure, which may vary in the dura-
app intervention for individuals with StD. Our hypotheses are as fol-
tion and requirements of core symptoms, but typically requires the
lows: (1) The adherence rate is ≥70%. (2) Participants would show
absence of MDD (Kroenke, 2017). An alternative definition of StD is
significantly greater changes in the symptoms of depression between
the presence of 2 to 4 criterion symptoms of depression for ≥2 week
pre- and post-intervention.
with at least one of the core symptoms (depressed mood or anhedo-
nia) (Kroenke, 2006; Rodríguez, Nuevo, Chatterji, & Ayuso-Mateos,
2012). Individuals with StD mainly face issues regarding self- 2 | METHODS
confidence (Chen et al., 2013). StD is also a strong risk factor for
MDD (Cuijpers & Smit, 2004). Therefore, StD should be seriously
2.1 | Study design
considered as a target for preventive intervention and treatment
(Kessler, Zhao, Blazer, & Swartz, 1997). This was an open-label, single-arm pre-post study for testing the fea-
Currently, owning a smartphone has become increasingly com- sibility and preliminary efficacy of an app intervention. The study was
mon, and the use of smartphone applications (apps) may help conducted from May 2017 to June 2017 in Takahashi, Okayama,

Early Intervention in Psychiatry. 2018;1–4. wileyonlinelibrary.com/journal/eip © 2018 John Wiley & Sons Australia, Ltd 1
2 TAKAHASHI ET AL.

Japan. The study was approved by the Ethics Committee of the Kibi 2.4.2 | Secondary outcomes
International University and registered at clinicaltrials.gov (Identifier: Usability and satisfaction
NCT03110016). Usability (ease of use and ease of learning) and satisfaction were
measured using the USE Questionnaire (Lund, 2001) at 5 weeks after
intervention. The USE questionnaires were constructed as seven-
2.2 | Participants and procedure point Likert rating scales. Participants were asked to rate their agree-

Participants were recruited from Kibi International University. The ment with the statements, ranging from strongly disagree to strongly

inclusion criteria were individuals (1) with an age of 18 to 24 years, agree (a score of 4 implied neither disagreement nor agreement). The

(2) with a Center for Epidemiologic Studies Depression Scale (CES-D) USE questionnaires were scored as disagree <4 < agree.

(Shima, Shikano, Kitamura, & Asai, 1985) score of ≥16 and (3) who
owned a smartphone with the iOS operating system. The exclusion Safety
criteria were individuals (1) with a lifetime history of MDD, (2) with a Safety was measured as the experience of major depressive episodes
lifetime history of bipolar disorder, (3) who were currently receiving according to the M.I.N.I (Sheehan & Lecrubier, 2003) at baseline and
treatment for a mental health problem from a mental health profes- 1, 2, 3, 4 and 5 weeks after initiating the intervention. We reported
sional, and (4) who had experienced a major depressive episode during the number of participants with serious adverse events.
the 2 weeks prior to the study, as ascertained using the Mini-
International Neuropsychiatric Interview (M.I.N.I) (Sheehan & Lecrubier, Preliminary efficacy
2003). Accordingly, 22 participants were included in the study. All par- Preliminary efficacy assessments were conducted at baseline and
ticipants provided written informed consent. The researcher helped the after 5 weeks. These included depressive symptoms assessed using
participants to install the app in their smartphones, and a brief explana- the CES-D (Shima et al., 1985), inflammatory biomarkers assessed
tion of the app was provided. Because the app was designed to be based on salivary interleukin (IL)-6 levels (Dowlati et al., 2010), gen-
user-friendly and self-explanatory, other than the embedded standard eral self-efficacy assessed using the General Self-Efficacy Scale
tutorials in the app, no further information or training was offered to (GSES) score (Sakano & Tohjoh, 1986), mental health assessed using
the participants during the study period. the 12-item General Health Questionnaire (GHQ-12) score
(Nakagawa & Daibo, 1985) and social anxiety assessed using the Lie-
bowitz Social Anxiety Scale (LSAS) score (Asakura et al., 2002).
2.3 | Intervention
The smartphone app (ie, SPSRS) used in the study was available in 2.5 | Statistical analyses
Japanese language and was free of charge for smartphones with iOS
The analysis was conducted based on the intention-to-treat principle.
9.0 or higher. The motion picture-reproducing app allows users to
Paired t-tests were used to detect differences in the pre- and post-
search for and watch videos by using keywords, similar to a general
intervention values of the outcome measures (CES-D, GSES, GHQ-
video playback app. This app uses a YouTube API. Therefore, partici-
12, LSAS scores and IL-6 levels). The magnitude of the within-group
pants can freely watch their favourite videos. The difference between
effect was determined as the effect size based on Cohen’s d for each
this app and YouTube apps is that in all videos, the SPSRS is pro-
scale ([Meanpre − Meanpost]/SDpooled) (Cohen, 1988). Effect sizes
grammed to display common words, such as “can,” “let us try,” “good
were categorized as small (0.20-0.49), medium (0.50-0.79), and large
luck,” “able” and “do not worry,” that can improve self-confidence in
(≥0.80) (Cohen, 1988). All statistical tests were two-tailed, and an
young adults with StD (Takahashi et al., 2017). These words are ran-
alpha value of <0.05 was considered statistically significant. Statistical
domly displayed in the four corners of the screen (for 17 ms each).
analyses were performed using IBM SPSS Statistics 24.0 for Win-
Soon afterwards, positive words such as “nice,” “great,” “fantastic,”
dows (IBM Corp., Armonk, New York).
“satisfactory” and “enjoyable” are displayed (Takarada & Nozaki,
2014). These words appear in the middle of the screen (for 150 ms
each). These words are repeatedly displayed every 5 seconds. Our 3 | RE SU LT S
intervention involved app use for at least 70 minutes per week over
5 weeks. The app focuses on increasing the motivation for beha-
3.1 | Baseline characteristics
vioural activation.
No participants dropped out during the study. Table 1 shows the
demographic data of the participants at baseline.

2.4 | Outcome measures


2.4.1 | Primary outcomes 3.2 | Primary outcome
Adherence rate 3.2.1 | Adherence rate
The adherence rate was calculated as the number of participants who Eleven participants completed the 5-week app intervention, that is,
used the SPSRS app for 70 minutes per week for 5 weeks divided by adherence throughout the intervention period (50% adherence rate).
the total number of participants. The mean time for app use over 5 weeks was 124.23  81.94 min/wk.
TAKAHASHI ET AL. 3

TABLE 1 Baseline characteristics of the participants 3.3.3 | Preliminary efficacy


Mean SD Table 2 shows the means and standard deviations (SD) of outcome
Age (y) 20 0.62 measures at the baseline (pre) and 5-weeks (post) time points. The
Sleep duration (h) 6.21 0.97 mean total CES-D scores significantly improved from 19.18 (SD,
3.05) to 14.50 (SD, 6.35) over the study period (P = .001). The post-
intervention within-group effect size was Cohen’s d = 0.94, which
N Percentage
corresponds to the large effect of the intervention. No significant
Sex
within-group differences in other outcome measures were observed.
Male 16 72.7

Female 6 27.3
Smoking habit 4 | DI SCU SSION
Smoker 5 22.7
To the best of our knowledge, this is the first study to evaluate the
Non-smoker 17 77.3
feasibility of a motion picture-reproducing app designed to improve
Drinking habit self-confidence in individuals suffering from StD. Despite good
Drinker 1 4.5 usability, the adherence rate was 50%. Typical reasons for not using
Non-drinker 21 95.5 the app included “related videos are not displayed” and “no habit of
Exercise habit watching motion pictures.” The app had a low satisfaction rate of
55%. One of the reasons was that participants were dissatisfied with
Present 9 40.9
the lack of related videos such as those on YouTube. We believe that
Absent 13 59.1
was the reason why the adherence rate declined. As a solution, we
thought that the app should display related videos such as those on
Typical reasons for not using the app included "no habit of watching YouTube. To solve “no habit of watching motion pictures” problem, a
motion pictures" and “related videos are not displayed.” pop-up message prompting the use of the app is required. Through
these improvements, by eliminating participants’ dissatisfaction and
putting in a habit of watching videos, the adherence rate and user
3.3 | Secondary outcomes satisfaction may also increase.
3.3.1 | Usability and satisfaction The results confirm that this app intervention is safe. Further-
more, this app could be a valid tool and may contribute to the reduc-
Totally, 91% (20/22) of participants agreed that the app was easy to
tion of depressive symptoms in young adults with StD. Our pre-post
use. The mean score of ease of use was 5.10  0.80 points. Further-
effect size of 0.94 (large effect) for the CES-D was larger than the
more, 100% (22/22) of participants agreed that the app was easy to
pre-post effect size of 0.51 (medium effect) reported in a previous
learn from. The mean score of ease of learning was 6.78  0.47
study (Walsh, Eisenlohr-Moul, & Baer, 2016) that employed a 4-week
points. Additionally, 55% (12/22) of participants agreed that the
mindfulness-based intervention. In addition, the results of this study
experience of using the app was satisfactory. The mean score of sat-
considerably exceed the measurement error of CES-D (Ohno et al.,
isfaction was 4.42  1.08 points.
2017). It has been shown that unconsciously presented information
can affect behaviour (Aoyama et al., 2017; Van den Bussche et al.,
3.3.2 | Safety 2009). In addition, behavioural activation mechanism theory suggests
No experience of major depressive episodes and no adverse events that behavioural activation decreases the symptoms of depression
that could have been related to intervention participation were (Manos, Kanter, & Busch, 2010). Therefore, we believe that positive
reported. words used in this app activate action and reduce the symptoms of

TABLE 2 Comparison of the pre- and post-intervention values of outcome measures

Pre Post ESa,b


Mean (SD) Mean (SD) Mean differences (SD) t P d 95% CI for ES
CES-D 19.18 (3.05) 14.50 (6.35) 4.68 (5.96) 3.69 .001 0.94 0.30, 1.54

IL-6 (pg/mL) 2.90 (6.85) 1.27 (5.80) 1.63 (4.20) 1.83 .08 0.26 −0.34, 0.85
GSES 6.36 (3.30) 7.23 (3.65) −0.87 (2.03) −2.00 .06 0.25 −0.35, 0.84

GHQ-12 14.18 (4.75) 12.41 (4.16) 1.77 (4.91) 1.69 .11 0.40 −0.21, 0.99
LSAS 50.36 (21.95) 50.14 (23.49) 0.22 (16.06) 0.07 .95 0.01 −0.58, 0.60

Abbreviations: CI, confidence interval; CES-D, Center for Epidemiologic Studies Depression Scale; ES, effect size; GHQ-12, 12-item General Health Ques-
tionnaire; GSES, General Self-Efficacy Scale; IL-6, level of salivary interleukin-6; LSAS, Liebowitz Social Anxiety Scale; SD, standard deviation.
a
Effect sizes are calculated such that positive values represent the improvement in all variables.
b
Effect sizes are calculated using pooled standard deviations of pre-treatment and post-treatment values.
4 TAKAHASHI ET AL.

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