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Evidence shows that computerized self-help interventions are effective for reducing symptoms of depression. One such intervention, SPARX, is a gamified mobile computerized cognitive behavioral therapy (cCBT) developed for adolescents in New Zealand, which was shown to be as effective as usual care for young people with mild-to-moderate symptoms of depression. However, gamified cCBT has not yet been tested in Japan.
This trial is designed to investigate whether a Japanese-adapted version of SPARX improves depressive symptoms in Japanese university students with mild-to-moderate depressive symptoms.
In this 7-week, multicenter, stratified, parallel-group, superiority randomized trial, participants will be allocated to either a treatment condition (SPARX) or a wait-list control condition. SPARX is a fully automated program, which will be delivered to the mobile phone or tablet device of the participants. SPARX is designed as an interactive fantasy game to guide the user through seven modules that teach key CBT strategies. All participants will be recruited from universities via advertisements on online bulletin boards, the campus newspaper, and posters. Participants in the treatment condition will use the SPARX program weekly. The primary outcome is the reduction of depressive symptoms (using Patient Health Questionnaires-9) measured at baseline and weekly: once after the 7-week intervention and once at a 1-month follow-up. Secondary outcomes include satisfaction with the program and satisfaction with life, measured by the Satisfaction With Life Scale; positive and negative moods, measured by the Profile of Mood States Second Edition; social functioning, measured by the EuroQol Instrument; rumination, measured by the Ruminative Responses Scale; and coping, measured by the Brief Coping Orientation to Problem Experienced Inventory.
This study received funding from The Research Institute of Personalized Health Sciences, Health Sciences University of Hokkaido, and obtained institutional review board approval in September 2019. Data collection began in April 2019.
Results of this trial may provide further evidence for the efficacy of gamified cCBT for the treatment of depression and, specifically, provide support for using SPARX with Japanese university students.
Japan Primary Registries Network UMIN000034354; https://tinyurl.com/uu7xd77
DERR1-10.2196/15164
Depression is a mental health problem commonly experienced by university students. A systematic review examining rates of depression among university students from a range of countries, including North American, European Union, East Asian, and Middle Eastern countries, revealed the weighted mean prevalence rate of depressive disorders of 30.6% [
In Japan, 126 of the 135 universities (93%) have some established support systems to address the mental health needs of university students [
In earlier studies, a variety of game-based interventions for mental health suggested potential benefits for mental and physical symptoms [
The primary objective of this trial is to examine whether SPARX improves depressive symptoms in Japanese university students who present mild-to-moderate symptoms. We hypothesize that SPARX will be more effective for improving depressive symptoms than a wait-list condition. In the systematic review of trials of internet-based and computer-delivered interventions for university students [
The secondary objectives are to determine whether SPARX delivered to Japanese students with mild-to-moderate depressive symptoms leads to (1) enhanced positive mood and reduced negative mood, (2) improved satisfaction with life, (3) improved health-related quality of life, (4) reduced depressive rumination, and (5) improved coping skills.
This is a multicenter trial and follows a stratified randomized, parallel-group superiority design. Participants will be randomized 1:1 to an intervention arm, which will consist of the game-based computerized CBT program SPARX or a wait-list control condition. Postintervention assessments will be carried out 7 weeks after baseline assessment. The participant flow through the trial is shown in
Participant flow of this trial. CES-D: Center for Epidemiological Studies Depression; SPARX: Smart, Positive, Active, Realistic, X-factor thoughts.
This multicenter study will be conducted at three universities: Health Sciences University of Hokkaido, Hokusho University, and Ritsumeikan University. We plan to recruit participants from April 2019 through March 2020.
A total of 100 participants will be sought to take part in this trial. Participants will be included in the trial if they meet the following inclusion criteria at the face-to-face or telephone eligibility interview: (1) mild-to-moderate depressive symptoms on the Center for Epidemiological Studies Depression Scale (CES-D) [
Participants will be excluded if they have: (1) high risk of self-harm or suicide at study entry based on a self-report; (2) severe depressive symptoms, as indicated by a CES-D score>24 [
For participants indicating a high risk of self-harm or suicide at screening and at any time during this trial, the researchers will provide information on available mental health care services that the participants can access and will ask the participant to cease participation in this trial. However, participants will be provided with ongoing access to SPARX even if they decide to withdraw from the trial. In relation to ancillary care, the participants will be allowed to contact the researchers at any point during the trial. If any event requiring additional care occurs, a researcher will inform the individual at the contact address or telephone number of the appropriate medical or psychological care and mental health service as provided by the participant’s health insurance.
All participants will be recruited from the abovementioned universities via advertisements on online bulletin boards, campus newspapers, and posters. Interested students who contact the researchers via email will be provided with further information related to the study and will be given time to consider their participation. If interested, they will be screened using Google forms (developed by the authors for this study) for eligibility using the Japanese version of the CES-D [
For participants in the treatment condition, SPARX will be delivered on their mobile phone or tablet device. They will be asked to play the SPARX program weekly at a designated university location (eg, a vacant laboratory or conference room) with one of the researchers (or a research assistant) present in another room (eg, a neighboring laboratory) for the purpose of checking SPARX use and being available to answer any questions from the participant. Each weekly session with SPARX is expected to take about 30 min.
Participants in the wait-list condition group will receive access to SPARX after a 1-month follow-up assessment of the treatment condition group. They will be asked to fill out assessments at the same time as the assessments of the treatment condition group at experimental laboratories, in conference rooms at each university, or on online Google forms. They will not be granted access to SPARX until all assessments have been completed.
To address potential issues of contamination, we forbid participants from talking about any theme of SPARX, such as the use of SPARX and any impressions of this study, during trial participation because other students in their university campus are participating in the current trial.
This study protocol was reviewed and approved by the institutional review board of Hokusho University (2017-021; February 20, 2018), Ritsumeikan University (2018-028; September 19, 2018), and Health Sciences University of Hokkaido (18-006, December 8, 2018). Furthermore, this study has been registered with UMIN (000034354). Details of this trial will be explained by the researchers to the participants before study participation. Written informed consent will be obtained from participants prior to entering them into the trial. All outcome data, including written informed consent, will be securely stored at the participating university (eg, Ritsumeikan University) in a locked cabinet. All identifying information will be removed, and the participants will only be identified by a unique participant number.
Participants (N=100) who fulfil all eligibility criteria will be randomized at a 1:1 ratio to either the SPARX intervention group or the wait-list control condition. The randomization sequence will be generated by the trial statistician and stratified by site. The final randomization lists will be computer-generated and concealed in a secure study database until the end of data collection/data lock.
A meta-analysis of RCTs examining the effects of CBT in comparison to wait-list on depression in university students showed an effect size of 1.13 [
A power analysis showed that a target sample size of 90 was needed to detect an effect size of 0.60 with alpha=.05 and a power of 0.80 for a two-tailed test. Considering an anticipated 10% dropout [
The treatment condition in this study consists of a game-based computerized CBT program called SPARX. It takes the form of an interactive fantasy game designed to take the user through seven modules that teach key CBT strategies. When the user begins SPARX, they meet the character of the Guide who introduces them to the “game world” and the challenges ahead, after which the user selects their avatar and begins the quest. Each module finishes with the avatar returning to the Guide who then explains how the “game skills” can be used in “real life”. The first module includes brief psychoeducation related to depression, with a brief introduction of relaxation (slow and controlled breathing) and hope. The remaining modules cover the following: activity scheduling/behavioral activation, interpersonal skills (communication, assertiveness, and negotiation), problem solving, cognitive restructuring (identifying common cognitive distortions and challenging negative thoughts), mindfulness, and relapse prevention (
Level 1 (finding hope): psychoeducation about depression, introduction to the cognitive behavioral therapy model, introducing gloomy negative automatic thoughts and “hope” (people recover from depression), relaxation (controlled breathing)
Level 2 (being active): activity scheduling, behavioral activation, relaxation (progressive muscle relaxation), basic communication, and interpersonal skills
Level 3 (dealing with emotions): dealing with anger and hurt feelings, interpersonal skills (assertiveness, listening, and negotiation)
Level 4 (overcoming problems): problem solving, cognitive restructuring (identifying smart, positive, active, realistic, X-factor thoughts)
Level 5 (recognizing unhelpful thoughts): cognitive restructuring (recognizing different types of gloomy negative automatic thoughts)
Level 6 (challenging unhelpful thoughts): cognitive restructuring (learning to challenge or swap negative thoughts for helpful ones), interpersonal skills continued (negotiation skills)
Level 7 (bringing it all together): recap of all skills, mindfulness (tolerating distress), relapse prevention
The Japanese version of SPARX was developed by the Japanese companies HIKARI Lab, Inc, and SmileBoom Co, Ltd, with approval of the developers of the original version. The original English language was translated into Japanese by the fourth author (AS) who has a master’s degree in clinical psychology and is a native Japanese speaker and a fluent speaker of English. A key difference between the original and Japanese versions was the change of the Guide character’s gender from male to female. In the original version, the Guide was male, stylized to look like a Maori (the indigenous people of New Zealand) chief to give a powerful impression. However, the developers in the Japanese version were concerned that this might not suit Japanese audiences and instead adopted a female character wearing a white national costume, with a more gentle and maternal expression (
Guide characters in the SPARX original (left) and Japanese (right) versions.
Participants randomized to the control group will be placed on a wait list for 11 weeks; that is, until after the 1-month follow-up assessment of the group assigned to the intervention. The participants on the wait list will then be offered the opportunity to take part in the SPARX program in the same way as those in the intervention group.
The primary outcome (Japanese version of PHQ-9) will be measured at baseline (T1), weekly throughout the interventions (T2-T7), at postassessment 1 week after the 7 intervention weeks (T8), and at 1-month follow-up (T9). Other assessments will be conducted at preassessment (T1), postassessment (T8), and 1-month follow-up (T9).
Overview of measurements.
Outcome | Scale | T1a | T2-T7b | T8c | T9d |
Demographics | Developed by the authors | ✓ |
|
|
|
Depressive symptoms | PHQ-9e | ✓ | ✓ | ✓ | ✓ |
Satisfaction with life | SWLSf | ✓ |
|
✓ | ✓ |
Negative and positive moods | POMS-2g | ✓ |
|
✓ | ✓ |
Social functions | EQ-5Dh | ✓ |
|
✓ | ✓ |
Rumination | RSSi | ✓ |
|
✓ | ✓ |
Coping | Brief COPEj | ✓ |
|
✓ | ✓ |
Stressor | DLSSk | ✓ |
|
✓ | ✓ |
Satisfaction and acceptability | Developed by the authors |
|
|
|
✓ |
aT1: baseline assessment (preassessment).
bT2-T7: assessment at each level.
cT8: assessment 1 week after the program.
dT9: assessment at 1-month follow-up.
ePHQ-9: Japanese version of Patient Health Questionnaire-9.
fSWLS: Satisfaction With Life Scale.
gPOMS-2: Profile of Mood Scale, second edition.
hEQ-5D: Japanese EuroQol instrument.
iRSS: Japanese version of the Ruminative Responses Scale.
jBrief COPE: Brief Coping Orientation to Problem Experienced inventory.
kDLSS: Daily Life Stress Scale for undergraduates.
The primary outcome measure is the Japanese version of PHQ-9. The PHQ-9 is a self-reported questionnaire for assessing depressive symptoms of the preceding 2 weeks [
The following sections will discuss the secondary measures used.
This is a self-reported questionnaire for assessing positive and negative moods during the preceding week [
This is a self-reported questionnaire for assessing satisfaction with life [
This is a self-reported questionnaire for assessing health-related quality of life [
This is a self-reported questionnaire for assessing the frequency of depressive rumination [
This is a self-rated questionnaire for assessing coping skills [
This is a self-reported questionnaire for assessing daily life stressors for undergraduates [
The final secondary outcome will be a measure of the satisfaction and acceptability of the intervention. All participants will be asked to rate four statements related to the perceived helpfulness, satisfaction with use, and the depth of understanding of the content of SPARX on an 11-point scale (0-10). Participants will also be able to write free text comments. The following questions will be asked: “How useful was this program for you [0 (not at all), 10 (very useful)]? Specifically, which components of this program were useful for you (write free text comments)?” “How satisfied are you with this program [0 (not at all), 10 (very satisfied)]?” “Please tell me about the pros and cons of this program (write free text comments)?” “How fun was this program for you [0 (not at all), 10 (very fun)]?” These items were developed specifically for the current trial.
The analysis for primary outcome measures will be conducted using a linear mixed model (LMM). The LMM approach was selected because of its strength in accommodating missing data and its ability to incorporate random effects into analyses. In these analyses, the dependent variable is the PHQ-9 score, and the independent variables are assignment (treatment condition, wait-list condition) and time [preassessment (T1), each session assessment (T2-T7), post-assessment (T8), and follow-up assessment (T9)], with interaction of the assignment and time as fixed-effect variables and participants as a random-effects variable. Secondary outcomes (outcome measures, process measures, and evaluation of the program) will be analyzed in the same way as the primary outcome. Subgroup analyses are not planned. For all analyses,
In the satisfaction/acceptability measure, free comments will be analyzed using thematic analysis.
The primary outcome is the presence of depressive symptoms at 1-month follow-up. Several secondary outcomes will be measured, such as positive and negative mood, satisfaction with life, health-related quality of life, depressive rumination, and coping skills. In addition, satisfaction and acceptability of the intervention will be measured, such as the perceived helpfulness, satisfaction with use, and the depth of understanding of the content of SPARX. Dropout rates will be measured to study the feasibility of SPARX.
This study received funding from The Research Institute of Personalized Health Sciences, Health Sciences University of Hokkaido, and obtained institutional review board approval in September 2019. Data collection began in April 2019. Study enrollment is still ongoing. As of April 2019, 60 subjects have been recruited and baseline data were collected. Moreover, 24 subjects have already been allocated to the treatment group and have begun the intervention. We expect to complete the study by March 2020, followed by data analysis and submission of the final report by the end of 2020.
Irrespective of the results, the results of this trial will be published in a peer-reviewed journal and communicated through presentations at national and international conferences. Study participants will be informed about the trial results via a plain-language summary of the results that will be sent to them. Academic papers and summary reports will be provided to the funders.
SPARX is a game-based intervention that was developed to deliver CBT for adolescents with depressive symptoms [
CONSORT-eHEALTH checklist (V 1.6.1).
Brief Coping Orientation to Problem Experienced inventory
cognitive behavioral therapy
Center for Epidemiological Studies Depression
Daily Life Stress Scale for undergraduates
EuroQol Instrument
linear mixed model
Patient Health Questionnaire-9
Profile of Mood States Second Edition
Ruminative Responses Scale
Smart, Positive, Active, Realistic, X-factor thoughts
Satisfaction With Life Scale
University Hospital Medical Information Network
All authors contributed equally to the study design by providing relevant intellectual input on all aspects of the study within several detailed discussions and meetings. MS and HM raised the research funding. AS developed the Japanese version of SPARX. MS and HM developed the original version of SPARX. KY drafted the manuscript. All authors revised the manuscript. All authors approved the version to be published.
AS developed the Japanese version of SPARX and would benefit financially from its commercialization. SM and KS are the codevelopers of the original version of SPARX in New Zealand. SM and KS receive commercialization royalties from any licensed use of SPARX, including Japan.