JoVE - Journal of Visualized Experiments
JoVE Visualize
Contact Us

Reasonable access to brief behavioural insomnia treatment among medical and psychiatric outpatients (RABBIT): a multicentre randomised controlled trial protocol

  • 0Faculty of Pharmacy and Pharmaceutical Sciences, Josai University, Saitama, Japan.
BMJ open +

|

May 22, 2025

Abstract

INTRODUCTION

Insomnia is a significant global health issue associated with substantial economic costs. International guidelines recommend cognitive behavioural therapy for insomnia (CBT-I) as the first-line treatment for chronic insomnia; however, pharmacotherapy remains more common in clinical practice. Maintaining the effectiveness while reducing the time and frequency of CBT-I is essential for its implementation. We conducted a randomised controlled trial (RCT) to evaluate the effectiveness of a brief behavioural treatment for insomnia (BBTI) that focuses on sleep restriction and stimulus control (SC)-both established as effective standalone interventions. This article presents the study protocol to examine whether adding BBTI to treatment as usual improves outcomes in patients with chronic insomnia.

METHODS AND ANALYSIS

We will conduct a multicentre RCT. We will randomly assign patients with chronic insomnia to two groups (BBTI vs sleep hygiene) in a 1:1 ratio. The BBTI consists of three 15 min sessions over 4 weeks delivered by healthcare professionals following a detailed manual. The primary outcome is the Insomnia Severity Index at 8 weeks. Secondary outcomes include sleep latency, wake after sleep onset, total sleep time, sleep efficiency, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9 and EuroQol-5D-5L. We will conduct the assessment at weeks 0 (baseline), 4 (end of intervention), 8 (post-intervention, primary endpoint) and 12 (follow-up). We will assess each sleep variable from the sleep diary at weeks 0 and 8. The analysis will be performed on an intention-to-treat basis.

ETHICS AND DISSEMINATION

This study has been approved by the Ethics Committee for Clinical and Epidemiological Research of Toyama University (approval no. R2023152).

TRIAL REGISTRATION NUMBER

UMIN000052911; pre-results.

Keywords:

Related Concept Videos

Management of Insomnia 01:19

235

The sleep cycle, an integral part of human health, consists of several stages with distinct characteristics and functions. It begins with a transition from wakefulness to sleep, known as the light sleep phase, followed by the restorative deep sleep phase, essential for physical recovery and growth. The cycle concludes with the Rapid Eye Movement (REM) phase, characterized by high brain activity and vivid dreaming. Insomnia, a prevalent sleep disorder, involves difficulty falling asleep, staying...

Blind Procedures 02:07

10.6K

Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...

Insomnia 01:27

81

Insomnia is a prevalent sleep disorder characterized by difficulty falling asleep, frequent awakenings during the night, and waking up too early without being able to return to sleep. People with insomnia often experience these disruptions at least three nights a week for at least one month. Chronic insomnia, which lasts for at least three months, can lead to increased anxiety, which in turn can worsen sleep difficulties, creating a cycle of sleeplessness and stress.
Multiple factors contribute...

Sedatives and Hypnotics Drugs: Miscellaneous Agents 01:17

159

Sedatives and hypnotics encompass a wide range of substances, each with its unique mechanism of action, uses, and potential adverse effects.
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...

Blinding 01:11

2.4K

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

The Placebo Effect 01:54

6.1K

The placebo effect occurs when people's expectations or beliefs influence or determine their experience in a given situation. In other words, simply expecting something to happen can actually make it happen.

The placebo effect is commonly described in terms of testing the effectiveness of a new medication. Imagine that you work in a pharmaceutical company, and you think you have a new drug that is effective in treating depression. To demonstrate that your medication is effective, you run...