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AIMS: This study aimed (1) to delineate how a web-based intervention affects the problem drinking behaviors of Japanese adults and (2) to examine the moderating effects of disorder levels and alcohol outcome expectancies on intervention outcomes. METHODS: We implemented an online two-armed parallel-group randomized controlled trial with 546 Japanese adults. Adults aged 20 years or older and who scored eight or higher on the Alcohol Use Disorder Identification Test were included in this study. Participants were randomly allocated to the intervention group or the waitlist/control group. The intervention comprised assessment of drinking behavior, personalized normative feedback, psychoeducation about the consequences of problem drinking, and a short quiz. The outcomes were weekly drinking quantity and abstinent days, largest drinking quantity in one day, and alcohol-related consequences reported at baseline and at one-, two-, and six-month follow-ups. A mixed-effects model regression was conducted to compare the intervention and control groups. RESULTS: The attrition rates at each follow-up were 52.93%, 49.45%, and 32.60%, respectively. The time × condition interaction effect on weekly drinking quantity was significant at the two- and six-month follow-ups, d = 0.28, 95% CI [0.04, 0.51], d = 0.34, 95% CI [0.05, 0.63], respectively. Moderations related to the intervention effect were not statistically significant. CONCLUSION: A web-based intervention was found to be effective for two and six months only on drinking quantity measures of Japanese adults with problem drinking. Limitations including high drop-out rates in are discussed.
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BACKGROUND: Recent years have seen an increase in the use of internet-based cognitive behavioral therapy in the area of mental health. Although lower effectiveness and higher dropout rates of unguided than those of guided internet-based cognitive behavioral therapy remain critical issues, not incurring ongoing human clinical resources makes it highly advantageous. OBJECTIVE: Current research in psychotherapy, which acknowledges the importance of therapeutic alliance, aims to evaluate the feasibility and acceptability, in terms of mental health, of an application that is embodied with a conversational agent. This application was enabled for use as an internet-based cognitive behavioral therapy preventative mental health measure. METHODS: Analysis of the data from the 191 participants of the experimental group with a mean age of 38.07 (SD 10.75) years and the 263 participants of the control group with a mean age of 38.05 (SD 13.45) years using a 2-way factorial analysis of variance (group × time) was performed. RESULTS: There was a significant main effect (P=.02) and interaction for time on the variable of positive mental health (P=.02), and for the treatment group, a significant simple main effect was also found (P=.002). In addition, there was a significant main effect (P=.02) and interaction for time on the variable of negative mental health (P=.005), and for the treatment group, a significant simple main effect was also found (P=.001). CONCLUSIONS: This research can be seen to represent a certain level of evidence for the mental health application developed herein, indicating empirically that internet-based cognitive behavioral therapy with the embodied conversational agent can be used in mental health care. In the pilot trial, given the issues related to feasibility and acceptability, it is necessary to pursue higher quality evidence while continuing to further improve the application, based on the findings of the current research.
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BACKGROUND: The literature shows that computer-delivered interventions with personalized normative feedback can reduce problem drinking for up to 6 months in the West. Meanwhile, no studies have been conducted to examine the effects of such interventions among Japanese problem drinkers. Possible moderators associated with effectiveness of the intervention need to be also explored. OBJECTIVE: The purpose of this study is to conduct a trial and examine the efficacy of a brief intervention with personal normative feedback and psychoeducation on several measures of alcohol consumption among Japanese problem drinkers. Additionally, this study will examine whether the level of alcohol use disorder and beliefs about the physical and psychological outcomes of drinking moderate the effect of the intervention on outcome measures. METHODS: This study will conduct a single-blind, 2-armed randomized controlled trial. Japanese adults with an Alcohol Use Disorder Identification Test score of 8 or higher will be enrolled in the trial. Participants allocated to the intervention group will receive the intervention immediately after the baseline measurements, and participants allocated to the waitlist group will receive the intervention at the end of the trial. Outcome measures include drinking quantity, drinking frequency, and alcohol-related consequences. Follow-up assessment will take place at 1 month, 2 months, and 6 months following the baseline measurement. The authors will not know the group allocation during trial. The authors will plan to collect a sample of 600 participants. Mixed-effect analyses of variance will be used to examine the main effects of condition, the main effects of time, and the interaction effects between condition and time on outcome variables. RESULTS: Enrollment for the trial began on January 6, 2018 and data are expected to be available by August 2018. CONCLUSIONS: This study will contribute to the literature by demonstrating the efficacy of Web-based screenings and brief interventions among Japanese problem drinkers and indicating several possible moderators between the intervention and outcomes. This type of Web-based brief intervention has the possibility of being implemented in Japanese schools and workplaces as a prevention tool. TRIAL REGISTRATION: UMIN Clinical Trials Registry R000034388; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000034388 (Archived by WebCite at http://www.webcitation.org/6xmOoTfTI). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10650.
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BACKGROUND: Research that investigates standalone effects of a mobile phone-based cognitive behavioral therapy without any human contact for reducing both psychological distress and risky drinking has been advancing; however, the number of studies is still limited. A mobile phone app called Self Record that facilitates cognitive restructuring through self-monitoring of daily thoughts and activities was developed in Japan. OBJECTIVE: This study conducted a nonrandomized controlled pilot trial of the Self Record app to investigate standalone effects of the intervention on psychological distress and alcohol consumption among Japanese workers. Additionally, we examined moderating effects of negative mood regulation expectancies, which are beliefs about one's ability to control one's negative mood. METHODS: A quasi-experimental design with a 1-month follow-up was conducted online in Japan from February 2016 to March 2016. A research marketing company recruited participants. The selection criteria were being a Japanese full-time worker (age 20-59 years), experiencing mild to moderate psychological distress, and having some interest in self-record apps. Assignment to group was based on participants' willingness to use the app in the study. All participants completed outcome measures of negative mood regulation expectancies, positive well-being, general distress, depression, anxiety, and typical/most weekly alcohol consumption. RESULTS: From the recruitment, 15.65% (1083/6921) of participants met the inclusion criteria. Of these, 51.43% (557/1083) enrolled in the study: 54.9% (306/557) in the intervention group and 45.1% (251/557) in the control group. At the 1-month follow-up, 15.3% (85/557) of participants had dropped out. Intention-to-treat analyses revealed that participants in the intervention group reported increased typical drinking (η2=.009) and heavy drinking (η2=.001). Adherence to using the app was low; 64.8% (199/306) of participants in the intervention group discontinued using the app on the first day. Additionally, 65.7% (366/557) of the total sample did not correctly answer the validity checks in the outcome measures (eg, "Please select 'mildly agree' for this item"). Therefore, per-protocol analyses were conducted after removing these participants. Results showed that continuing app users (42/127) in the intervention group reported increases in anxiety (η2=.006), typical drinking (η2=.005), and heavy drinking (η2=.007) compared to those in the control group (85/127). Negative mood regulation expectancies moderated the effects of the intervention for general distress (beta=.39). CONCLUSIONS: Results were contrary to our hypotheses. Self-recording methods of standalone mobile phone interventions may heighten individuals' awareness of their pathological thought and drinking behavior, but may be insufficient to decrease them unless combined with a more intense or face-to-face intervention. Limitations include high attrition in this study; measures to improve the response rate are discussed.