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Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Mar 17, 2021
Date Accepted: Dec 12, 2021

The final, peer-reviewed published version of this preprint can be found here:

Effectiveness of Unguided Internet-Based Cognitive Behavioral Therapy and the Three Good Things Exercise for Insomnia: 3-Arm Randomized Controlled Trial

Sato D, Sekizawa Y, Sutoh C, Hirano Y, Okawa S, Hirose M, Takemura R, Shimizu E

Effectiveness of Unguided Internet-Based Cognitive Behavioral Therapy and the Three Good Things Exercise for Insomnia: 3-Arm Randomized Controlled Trial

J Med Internet Res 2022;24(2):e28747

DOI: 10.2196/28747

PMID: 35138259

PMCID: 8867295

Effectiveness of Unguided Internet-based Cognitive Behavioral Therapy and the Three Good Things Exercise for Insomnia: A Three-arm Randomized Controlled Trial

  • Daisuke Sato; 
  • Yoichi Sekizawa; 
  • Chihiro Sutoh; 
  • Yoshiyuki Hirano; 
  • Sho Okawa; 
  • Motohisa Hirose; 
  • Ryo Takemura; 
  • Eiji Shimizu

ABSTRACT

Background:

The treatment of insomnia with sleep medication causes problems such as long-term use, dependence, and significant economic losses, including medical expenses. Evidence-based lifestyle guidance is required to improve insomnia symptoms, not only in person but also in easy-to-use online formats.

Objective:

This study aimed to clarify whether unguided internet cognitive behavioral therapy (ICBT) or the three good things (TGT) exercise, both administered as self-help internet interventions without e-mail support, could improve insomnia symptoms compared to a waiting list control (WLC) group.

Methods:

A four week program was implemented, and participants were randomly allocated to one of the three groups. The primary outcome measure was Pittsburgh Sleep Questionnaire (PSQI) score at four weeks compared to baseline.

Results:

Of the 21,394 individuals who were invited to participate, 312 met the eligibility criteria and were randomly assigned to one of the three groups. Of these, 270 subjects (ICBT; n = 79, TGT; n = 88, WLC; n = 103) completed a post-intervention survey at four and eight weeks. The adjusted mean changes of the primary outcome measure (the Pittsburgh Sleep Questionnaire; PSQI) in the ICBT (-1.56, 95% CI: -2.52, -0.59; p <0.001) and TGT (-1.15, 95% CI: -2.08, -0.23; p = 0.0018) groups at four weeks from baseline showed a significant improvement compared to the WLC. The adjusted mean changes of the secondary outcome measures in sleep onset latency, total sleep time (TST), Athens Insomnia Scale (AIS) score, and Patient Health Questionnaire-9 (PHQ-9) score at four weeks from baseline, as well as in the PSQI at eight weeks from baseline, showed significant improvement in the ICBT. Moreover, TST, AIS and PHQ-9 scores at four weeks from baseline showed a significant improvement in the TGT group compared to the WLC.

Conclusions:

Four weeks of unguided ICBT and the TGT exercises improved insomnia. Clinical Trial: The trial is registered with the UMIN Clinical Trial Registry (UMIN000034927)


 Citation

Please cite as:

Sato D, Sekizawa Y, Sutoh C, Hirano Y, Okawa S, Hirose M, Takemura R, Shimizu E

Effectiveness of Unguided Internet-Based Cognitive Behavioral Therapy and the Three Good Things Exercise for Insomnia: 3-Arm Randomized Controlled Trial

J Med Internet Res 2022;24(2):e28747

DOI: 10.2196/28747

PMID: 35138259

PMCID: 8867295

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