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

Feb 1, 2018BMJ open

Trial of online cognitive-behavioral therapy for people with insomnia still having symptoms after sleeping pills

AI simplified

Circadian Biology on OpenScience ↗PubMed ↗DOI ↗

Abstract

A randomized controlled trial will evaluate the effectiveness of a five-step internet-delivered cognitive-behavioral therapy for insomnia with 30 participants.

Participants diagnosed with insomnia who continue to experience symptoms after medication will be included.
The trial consists of two groups: one receiving internet-delivered cognitive-behavioral therapy plus usual care and the other receiving usual care alone.
Primary outcome measurement will be insomnia severity assessed using the Pittsburgh Sleep Quality Index at week 6.
Secondary outcomes will include various sleep quality metrics, anxiety, depression, and quality of life assessed at baseline, postintervention, and follow-up.
Intention-to-treat analysis will be applied for statistical evaluation.

AI simplified

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.

Full Text

We can’t show the full text here under this license. Use the link below to read it at the source.

View full text ↗

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

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief