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BMJ Open. 2018 Jan 30;8(1):e018220. doi: 10.1136/bmjopen-2017-018220.

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.

Author information

1
Departments of Cognitive Behavioral Physiology, Chiba University Graduate School of Medicine, Chiba, Japan.
2
Department of Rehabilitation Sciences, Faculty of Health Care Sciences, Chiba Prefectural University of Health Sciences, Chiba, Japan.
3
Organization for Promotion of Tenure Track, University of Miyazaki, Miyazaki, Japan.
4
Clinical Research Center, Chiba University Hospital, Chiba, Japan.
5
Department of Global Clinical Research, Graduate School of Medicine, Chiba University, Chiba, Japan.
6
Cognitive Behavioral Therapy Center, Chiba University Hospital, Chiba, Japan.
7
Research Center for Child Mental Development, Chiba University, Chiba, Japan.

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.

KEYWORDS:

cognitive behavioral therapy; insomnia; internet; randomized controlled Trial

PMID:
29382675
PMCID:
PMC5829590
DOI:
10.1136/bmjopen-2017-018220
[Indexed for MEDLINE]
Free PMC Article

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