Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial.

BACKGROUND: Insomnia is a highly prevalent disorder causing clinically significant distress and impairment. Furthermore, insomnia is associated with high societal and individual costs. Although cognitive behavioural treatment for insomnia (CBT-I) is the preferred treatment, it is not used often. Offering CBT-I in an online format may increase access. Many studies have shown that online CBT for insomnia is effective. However, these studies have all been performed in general population samples recruited through media. This protocol article presents the design of a study aimed at establishing feasibility, effectiveness and cost-effectiveness of a guided online intervention (i-Sleep) for patients suffering from insomnia that seek help from their general practitioner as compared to care-as-usual. METHODS/DESIGN: In a pragmatic randomized controlled trial, adult patients with insomnia disorder recruited through general practices are randomized to a 5-session guided online treatment, which is called "i-Sleep", or to care-as-usual. Patients in the care-as-usual condition will be offered i-Sleep 6 months after inclusion. An ancillary clinician, known as the psychological well-being practitioner who works in the GP practice (PWP; in Dutch: POH-GGZ), will offer online support after every session. Our aim is to recruit one hundred and sixty patients. Questionnaires, a sleep diary and wrist actigraphy will be administered at baseline, post intervention (at 8 weeks), and at 6 months and 12 months follow-up. Effectiveness will be established using insomnia severity as the main outcome. Cost-effectiveness and cost-utility (using costs per quality adjusted life year (QALY) as outcome) will be conducted from a societal perspective. Secondary measures are: sleep diary, daytime consequences, fatigue, work and social adjustment, anxiety, alcohol use, depression and quality of life. DISCUSSION: The results of this trial will help establish whether online CBT-I is (cost-) effective and feasible in general practice as compared to care-as-usual. If it is, then quality of care might be increased because implementation of i-Sleep makes it easier to adhere to insomnia guidelines. Strengths and limitations are discussed. TRIAL REGISTRATION: Netherlands Trial register NTR 5202 (registered April 17(st) 2015)

Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis

Insomnia is a major public health problem considering its high prevalence, impact on daily life, comorbidity with other disorders and societal costs. Cognitive behavioral treatment for insomnia (CBTI) is currently considered to be the preferred treatment. However, no meta-analysis exists of all studies using at least one component of CBTI for insomnia, which also uses modern techniques to pool data and to analyze subgroups of patients. We included 87 randomized controlled trials, comparing 118 treatments (3724 patients) to non-treated controls (2579 patients). Overall, the interventions had significant effects on: insomnia severity index (g ¼ 0.98), sleep efficiency (g ¼ 0.71), Pittsburgh sleep quality index (g ¼ 0.65), wake after sleep onset (g ¼ 0.63) and sleep onset latency (SOL; g ¼ 0.57), number of awakenings (g ¼ 0.29) and sleep quality (g ¼ 0.40). The smallest effect was on total sleep time (g ¼ 0.16). Faceto- face treatments of at least four sessions seem to be more effective than self-help interventions or faceto- face interventions with fewer sessions. Otherwise the results seem to be quite robust (similar for patients with or without comorbid disease, younger or older patients, using or not using sleep medication). We conclude that CBTI, either its components or the full package, is effective in the treatment of insomnia

Intravascular optical coherence tomography imaging at 3200 frames per second

We demonstrate intravascular optical coherence tomography (OCT) imaging with frame rate up to 3.2 kHz (192,000 rpm scanning). This was achieved by using a custom-built catheter in which the circumferential scanning was actuated by a 1.0 mm diameter synchronous motor. The OCT system, with an imaging depth of 3.7 mm (in air), is based on a Fourier domain mode locked laser operating at an A-line rate of 1.6 MHz. The diameter of the catheter is 1.1 mm at the tip. Ex vivo images of human coronary artery (78.4 mm length) were acquired at a pullback speed of 100 mm/s. True 3D volumetric imaging of the entire artery, with dense and isotropic sampling in all dimensions, was performed in < 1 second acquisition time. (C) 2013 Optical Society of Americ

Ultrahigh-speed intravascular optical coherence tomography imaging at 3200 frames per second

We demonstrated intravascular OCT imaging with frame rate up to 3.2 kHz (192,000 rpm scanning). This was achieved by using a custom-built catheter in which the circumferential scanning was actuated by a 1.0 mm diameter synchronous motor. The OCT system was based on a Fourier Domain Mode Locked laser operating at an A-line rate of 1.6 MHz. The diameter of the catheter was 1.1 mm at the tip. Ex vivo images of human coronary artery (~78.4 mm length) were acquired at a pullback speed of 100 mm/s. True 3D volumetric imaging of the entire artery, with adequate sampling in all dimensions, was performed in &lt; 1 second acquisition time.</p

Heartbeat OCT:Superfast imaging and elasticity detection

Intravascular Optical Coherence Tomography (IV-OCT) has generated a wealth of data that has deepened our understanding of coronary artery disease and catheter-based interventions on the vasculature. A number of issues, however – cardiac motion artifacts, undersampling and non-uniform rotational distortion (NURD) chiefly among them – affect the quality and interpretability of IV-OCT images

Heartbeat OCT: in vivo intravascular megahertz-optical coherence tomography

Cardiac motion artifacts, non-uniform rotational distortion and undersampling affect the image quality and the diagnostic impact of intravascular optical coherence tomography (IV-OCT). In this study we demonstrate how these limitations of IV-OCT can be addressed by using an imaging system that we called "Heartbeat OCT", combining a fast Fourier Domain Mode Locked laser, fast pullback, and a micromotor actuated catheter, designed to examine a coronary vessel in less than one cardiac cycle. We acquired in vivo data sets of two coronary arteries in a porcine heart with both Heartbeat OCT, working at 2.88 MHz A-line rate, 4000 frames/s and 100 mm/s pullback speed, and with a commercial system. The in vivo results show that Heartbeat OCT provides faithfully rendered, motion-artifact free, fully sampled vessel wall architecture, unlike the conventional IV-OCT data. We present the Heartbeat OCT system in full technical detail and discuss the steps needed for clinical translation of the technology. (C) 2015 Optical Society of Americ

Media 1: Intravascular optical coherence tomography imaging at 3200 frames per second

Originally published in Optics Letters on 15 May 2013 (ol-38-10-1715