Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Nov 4, 2018
Open Peer Review Period: Nov 4, 2018 - Dec 5, 2018
Date Accepted: Dec 21, 2018
(closed for review but you can still tweet)
Effectiveness of Internet-Delivered Computerized Cognitive Behavioral Therapy for Patients with Insomnia Who Remain Symptomatic Following Pharmacotherapy: A Randomized Controlled Exploratory Trial
ABSTRACT
Background:
In reality, pharmacotherapy still remains the most common treatment for insomnia. 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.
Objective:
We examined the effectiveness of our ICBT program as an adjunct to UC compared with UC alone in patients with insomnia who remain symptomatic following hypnotics.
Methods:
We recruited 23 patients with insomnia who remain symptomatic following pharmacologic treatment including benzodiazepines, and we conducted a exploratory randomized controlled trial. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at week 6 of treatment. Secondary outcomes were the sleep onset latency (SOL), total sleep time (TST), sleep efficiency (SE), number of awakenings (NA), refreshment and soundness of sleep, anxiety by Hospital Anxiety and Depression Scale (HADS), depression measured by the Center for Epidemiologic Studies Depression Scale (CES-D), and quality of life measured by the EuroQol-5D (EQ-5D). All parameters were measured at weeks 0 (baseline), 6 (post-intervention), and 12 (follow-up).
Results:
The adjusted mean reduction (−6.11) in PSQI at week 6 from baseline in the ICBT+UC group was significantly (p<0.001) larger than that (0.40) in the UC group. Significant differences were also found in favor of ICBT+UC for PSQI, SOL, SE, NA and depression at all assessment points. Refreshment, soundness of sleep, anxiety, and quality of life improved by week 6 in ICBT+UC compared with UC. There were no reports of adverse events in either group during the study.
Conclusions:
These results indicate that our 6-week ICBT program is an effective treatment adjunct to UC for improving insomnia and related symptoms even after unsuccessful pharmacotherapy. Clinical Trial: UMIN000021509. Trial name: Effectiveness study of internet-based cognitive behavioral therapy for insomnia: A pilot randomized controlled trial. URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000023545
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