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

Daisuke Sato,Kazue Nagai,Eiji Shimizu,Eiichi Nagai,Naoki Yoshinaga

doi:10.2196/12686

Abstract

BackgroundIn reality, pharmacotherapy still remains the most common treatment for insomnia.ObjectiveThis 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.MethodsWe 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).ResultsThe 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.ConclusionsThese 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 RegistrationUniversity 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).

Highlights

BackgroundInsomnia, which affects 10% to 12% of the total population, is characterized by the inability to fall asleep or awakening too early in the morning or during the night, resulting in nonrestorative sleep and decreased daytime functioning [1,2,3,4]
These results indicated that our 6-week internet-delivered computerized cognitive behavioral therapy (ICBT) program is an effective treatment adjunct to usual care (UC) for improving insomnia and related symptoms even after unsuccessful pharmacotherapy
We conducted the randomized controlled trial (RCT) to examine the effectiveness of ICBT as an adjunct to usual care (UC) compared with UC alone, targeting insomnia patients who remain symptomatic after pharmacotherapy

Summary

Introduction

BackgroundInsomnia, which affects 10% to 12% of the total population, is characterized by the inability to fall asleep or awakening too early in the morning or during the night, resulting in nonrestorative sleep and decreased daytime functioning [1,2,3,4]. The treatment options for insomnia are psychotherapy and pharmacotherapy, and the American College of Physicians (ACP) recommends that all adult patients receive cognitive behavioral therapy (CBT) for insomnia as the initial treatment for chronic insomnia disorder. The ACP recommends that clinicians use a shared decision-making approach, including a discussion with the patient, of the benefits, harms, and costs of the short-term use of medications before deciding whether to add pharmacological therapy in adults with chronic insomnia disorder in whom CBT for insomnia alone was unsuccessful [6]. In 2005, Vallières et al reported that pharmacotherapy before the initiation of CBT appears to be less effective than the combined treatment of pharmacotherapy plus CBT, followed by CBT alone [7]. Their study revealed that the early introduction of CBT contributes to a maximization of the effect of pharmacotherapy. Pharmacotherapy still remains the most common treatment for insomnia

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