Effectiveness Study of Internet-based Cognitive Behavioral Therapy and Three Good Things Exercise for Insomnia: a three-arm randomized controlled trial

Author Name SATO Daisuke (Chiba University) / SEKIZAWA Yoichi (Senior Fellow, RIETI) / SUTOH Chihiro (Chiba University) / HIRANO Yoshiyuki (Chiba University) / OKAWA Sho (Chiba University) / HIROSE Motohisa (Chiba University) / TAKEMURA Ryo (Keio University) / SHIMIZU Eiji (Chiba University)
Creation Date/NO. April 2020 20-J-019
Research Project Exploring Inhibition of Medical Expenditure Expansion and Health-oriented Business Management Based on Evidence-based Medicine
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Objective: In Japan, the treatment of insomnia with sleeping pills, which is not always effective, causes problems such as long-term use, dependence, and a harmful combination of multiple drugs, leading to significant economic losses, including increased medical expenses. From the perspective of optimizing medical costs, it is essential to introduce not only drug treatment but also evidence-based lifestyle guidance and provide an insomnia improvement program not only in person but also as easy-to-use online lifestyle guidance. If successful, medical expenses are expected to be moderated. Therefore, in this study, either the Internet Cognitive Behavioral Therapy (ICBT) group or the "Three Good Things" (TGT) of Positive Psychology Exercise (PPE) group were compared with the wait-listing control group (the group that did nothing, WLC) in 4 groups, respectively. The purpose of this study was to clarify whether the patient had statistically significant improvements in insomnia symptoms immediately after the weekly intervention period.

Methods: We examined the effectiveness of self-directed Internet intervention without external e-mail support as non-invasive self-medication for adults with insomnia. Three groups, namely the (1) ICBT group, (2) TGT group, and (3) WLC group were set, a 4-week program was implemented, and a randomized controlled trial of three groups was performed. Pittsburgh Sleep Questionnaire (PSQI) was measured at four weeks as the primary endpoint and again at eight weeks, and sleep onset latency (SOL) at four weeks and eight weeks as secondary endpoints. Sleep time (TST), sleep efficiency (SE), Athens Insomnia Scale (AIS), General Anxiety Disorder 7-item scale (GAD-7), Patient Health Questionnaire-9 (PHQ-9), were conducted for epidemiological studies of depression. We measured Center for Epidemiologic Studies Depression Scale (CES-D), a general confidence scale, and consumer attitude index.

Results: Of the 21,394 people who applied to participate through the Internet registration portal, 312 people who met the eligibility criteria were randomly assigned to the study groups (106 in the ICBT group, 103 in the TGT group, 103 in the WLC group) for a 4-week intervention program. and 270 subjects (79 in the ICBT group, 88 in the TGT group, and 103 in the WLC group), who underwent a post-intervention survey at weeks 4 and 8, were included in the analysis. The adjusted mean changes in PSQI in the ICBT and TGT groups at four weeks from baseline both showed a significant improvement compared to the WLC group. The adjusted mean differences in SOL, TST, AIS, PHQ-9 at four weeks from baseline, and PSQI at eight weeks from baseline each showed significant improvement in the ICBT group compared to the WLC group. The adjusted mean changes in TST, AIS, and PHQ-9 at four weeks from baseline in the TGT group each showed significant improvement compared to the WLC group. Adjusted mean changes at 4 and 8 weeks from baseline in CES-D, general confidence scale, and consumer attitude index showed no significant differences in ICBT and TGT groups compared to the WLC group.

Conclusions: Internet cognitive behavioral therapy and the "Three Good Things" exercise each provided significant improvements to insomnia symptoms within the four-week study period.