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Randomized Controlled Trial
. 2019 Apr 11;21(4):e12686.
doi: 10.2196/12686.

Effectiveness of Internet-Delivered Computerized Cognitive Behavioral Therapy for Patients With Insomnia Who Remain Symptomatic Following Pharmacotherapy: Randomized Controlled Exploratory Trial

Daisuke Sato #  1   2 , Naoki Yoshinaga  3 , Eiichi Nagai  4 , Kazue Nagai  5 , Eiji Shimizu  1   6   7
Affiliations
Randomized Controlled Trial

Effectiveness of Internet-Delivered Computerized Cognitive Behavioral Therapy for Patients With Insomnia Who Remain Symptomatic Following Pharmacotherapy: Randomized Controlled Exploratory Trial

Daisuke Sato et al. J Med Internet Res. .

Abstract

Background: In reality, pharmacotherapy still remains the most common treatment for insomnia.

Objective: This study aimed to examine the effectiveness of our internet-delivered computerized cognitive behavioral therapy (ICBT) program as an adjunct to usual care (UC) compared with UC alone in patients with insomnia who remain symptomatic following hypnotics.

Methods: We recruited 23 patients with insomnia who remained symptomatic following pharmacologic treatment including benzodiazepines, and we conducted an exploratory randomized controlled trial. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at week 6 of the treatment. Secondary outcomes were sleep onset latency, total sleep time, sleep efficiency, number of awakenings, refreshment and soundness of sleep, anxiety by Hospital Anxiety and Depression Scale, depression measured by the Center for Epidemiologic Studies Depression Scale, and quality of life (QOL) measured by the EuroQol-5D. All parameters were measured at weeks 0 (baseline), 6 (postintervention), and 12 (follow-up).

Results: The adjusted mean reduction (-6.11) in PSQI at week 6 from baseline in the ICBT plus UC group was significantly (P<.001) larger than the adjusted mean reduction (0.40) in the UC alone group. Significant differences were also found in favor of ICBT plus UC for PSQI, sleep onset latency, sleep efficiency, number of awakenings, and depression at all assessment points. Refreshment, soundness of sleep, anxiety, and QOL improved by week 6 in ICBT plus UC compared with UC alone. There were no reports of adverse events in either group during the study.

Conclusions: These results indicated that our 6-week ICBT program is an effective treatment adjunct to UC for improving insomnia and related symptoms even after unsuccessful pharmacotherapy.

Trial registration: University Hospital Medical Information Network Clinical Trials Registry: UMIN000021509; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023545 (Archived by WebCite at http://www.webcitation. org/75tCmwnYt).

Keywords: benzodiazepines; cognitive behavioral therapy; insomnia; internet; randomized controlled trial; residual symptoms.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
The CONSORT flow diagram for the trial. ICBT: internet-delivered computerized cognitive behavioral therapy; UC: usual care.
Figure 2
Figure 2
Mean and SDs (raw data) for the primary outcome, the Pittsburgh Sleep Quality Index (PSQI) score improvement. ICBT: internet-delivered computerized cognitive behavioral therapy; UC: usual care.
See this image and copyright information in PMC

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References

    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders: DSM-5. Washington: American Psychiatric Publishing; 2013. May 22, 5th ed.
    1. Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97–111. doi: 10.1053/smrv.2002.0186.S1087079202901863 - DOI - PubMed
    1. Lichstein KL, Durrence HH, Reidel BW, Taylor DJ, Bush AJ. Epidemiology of Sleep: Age, Gender, and Ethnicity. Mahwah, New York: Lawrence Erlbaum Associates Publishers; 2004. pp. 202–216.
    1. Morphy H, Dunn KM, Lewis M, Boardman HF, Croft PR. Epidemiology of insomnia: a longitudinal study in a UK population. Sleep. 2007 Mar;30(3):274–80. - PubMed
    1. Morin CM, Bélanger L, LeBlanc M, Ivers H, Savard J, Espie CA, Mérette C, Baillargeon L, Grégoire JP. The natural history of insomnia: a population-based 3-year longitudinal study. Arch Intern Med. 2009 Mar 09;169(5):447–53. doi: 10.1001/archinternmed.2008.610.169/5/447 - DOI - PubMed

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