You are here

  • Home
  • Archive
  • Volume 8, Issue 1
  • Randomised controlled trial on the effect of internet-delivered computerised cognitive–behavioural therapy on patients with insomnia who remain symptomatic following hypnotics: a study protocol

Article Text

Article menu

Download PDFPDF

XML
Mental health
Protocol
Randomised controlled trial on the effect of internet-delivered computerised cognitive–behavioural therapy on patients with insomnia who remain symptomatic following hypnotics: a study protocol
  1. Daisuke Sato1,2,
  2. Naoki Yoshinaga3,
  3. Eiichi Nagai4,
  4. Hideki Hanaoka4,
  5. Yasunori Sato5,
  6. Eiji Shimizu1,6,7
  1. 1 Departments of Cognitive Behavioral Physiology, Chiba University Graduate School of Medicine, Chiba, Japan
  2. 2 Department of Rehabilitation Sciences, Faculty of Health Care Sciences, Chiba Prefectural University of Health Sciences, Chiba, Japan
  3. 3 Organization for Promotion of Tenure Track, University of Miyazaki, Miyazaki, Japan
  4. 4 Clinical Research Center, Chiba University Hospital, Chiba, Japan
  5. 5 Department of Global Clinical Research, Graduate School of Medicine, Chiba University, Chiba, Japan
  6. 6 Cognitive Behavioral Therapy Center, Chiba University Hospital, Chiba, Japan
  7. 7 Research Center for Child Mental Development, Chiba University, Chiba, Japan
  1. Correspondence to Daisuke Sato; daisu.sato{at}gmail.com

Abstract

Introduction Insomnia has severe consequences for health. Primary care physicians in Japan commonly provide hypnotics, which is far from optimal. The recommended treatment for insomnia is cognitive–behavioural therapy (CBT). Access to trained therapists, however, is limited. Rather than face-to-face CBT, several researchers have studied internet-delivered computerised CBT (ICBT). This paper describes the study protocol for a randomised controlled trial (RCT) to evaluate effectiveness and feasibility of our newly developed five-step ICBT as an adjunct to usual care (UC) compared with UC alone for patients with insomnia who remain symptomatic following hypnotics.

Methods and analysis This proposed exploratory RCT comprises two parallel groups (ICBT+UC and UC alone) consisting of 15 participants each (n=30) diagnosed with insomnia who remain symptomatic after pharmacotherapy. We aim to evaluate the effectiveness of six intervention weeks. The primary outcome of insomnia severity will be the Pittsburgh Sleep Quality Index (PSQI) at week 6. Secondary outcomes include sleep onset latency, total sleep time, sleep efficiency extracted from PSQI, current feeling of refreshment and perceived soundness of sleep measured using visual analogue scale, number of awakenings, anxiety by Hospital Anxiety and Depression Scale, depression by Center for Epidemiologic Studies Depression Scale and quality of life by Euro Qol-5D. All measures will be assessed at weeks 0 (baseline), 6 (postintervention) and 12 (follow-up), and intention-to-treat analysis will be applied. The statistical analysis plan has been developed considering design of field materials.

Ethics and dissemination This study will be conducted at the academic outpatient clinic of Chiba University Hospital, Japan. Ethics approval was granted by the Institutional Review Board of Chiba University Hospital. All participants will be required to provide written informed consent. The trial will be implemented and reported in accordance with Consolidated Standards of Reporting Trials recommendations.

Trial registration number UMIN000021509; Pre-results.

  • cognitive behavioral therapy
  • insomnia
  • randomized controlled Trial
  • internet

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-018220

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors DS and ES especially made contribution to the design of this study, development of the original study protocol and drafting the initial manuscript. YS contributed to develop the statistical analysis plan and assisted in the preparation of the manuscript. NY, EN and HH contributed to the conceptualisation and design of this study and the critical revision of the article for important intellectual content. All authors approved the final version of the manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately resolved.

    • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The study protocol has been approved by the Institutional Review Board of the Chiba University Hospital (reference number: G27040) on December 2015.

    • Provenance and peer review Not commissioned; externally peer reviewed.