The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men

BACKGROUND: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes.METHODS/DESIGN: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited. The primary outcome is change in the severity of depressive symptoms from baseline to week 12. DISCUSSION: This study will provide evidence on whether a widely accessible, evidence-based, internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone, in a group who traditionally do not readily access psychotherapy. The study is designed to establish effect size, feasibility and processes associated with implementing e-health solutions alongside standard clinical care, to warrant undertaking a larger more definitive clinical trial.Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886.The study is supported by beyondblue: the national depression and anxiety initiative National Priority Driven Research Program and funded through a donation from the Movember Foundation

Quantifying the Benefits of Enhancing Medications on Driving Performance: Comparing OROS ® MPH vs. se-AMPH ER ® in Driving Safety of ADHD Teenagers as Case Example

Driving simulation is the best way to safely and reliably assess theimpact of medical parameters on driving in a controlled, replicable environment,Driving performance should be evaluated using a composite driving score, sincethe pathway to impaired driving is highly idiosyncratic and could involve anynumber of individual driving parameters. Although simulators still do not haveaccepted standards for hardware, driving scenarios, or performance variables, wepropose a partial solution to permit comparisons of composite scores acrosssimulators. We recommend presenting simulator data via a standardized averageeffect size, which we call the Impaired Driving Score (IDS). We describe how theIDS is calculated, and present data comparing 16 male and 15 female teenagedrivers with ADHD who participated in a double-blind, placebo-controlled, crossoverstudy. Using an equivalent-dose regimen, we compared the effects of 72 mgof OROS® MPH (Concerta®), 30mg of se-AMPH XR® (Adderall XR®) andplacebo on driving performance. Participants drove our Atari Research DrivingSimulator at 5, 8, and 11 pm under all three medication conditions with at least aweek between conditions/drives. The primary outcome measure was participants’IDS. Across all three times, performance on Concerta® was superior to placebo(p=.005), while Adderall XR® was not (p=.14). When analyzed separately,however, only one variable was statistically significant (seconds spent speeding,p<.01). Composite driving scores permit the comparison of driving performanceacross various experimental conditions and with a normative database.Furthermore, since the IDS is based on a multi-faceted assessment of drivingperformance, it is less vulnerable to random effects and offers a more robustindicator of driving performance

Online cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia among individuals with alcohol use disorder: study protocol for a randomized controlled trial

Abstract Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia. Internet-based CBT-I could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound Internet intervention for insomnia. Despite the promise of Internet-based CBT-I interventions, to date, no randomized controlled trials (RCTs) exist examining the feasibility/efficacy of an Internet-based CBT-I program among treatment-seeking individuals recovering from AUD. This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia. Phase I will focus on assessing the feasibility and acceptability of program delivery and data collection (n = 10). Phase II will be an RCT powered to examine preliminary intervention efficacy (n = 30 per group). Participants for this study must meet criteria for “moderate to severe” insomnia. Individuals randomized to the intervention group will receive the SHUTi intervention (initiated while inpatient and completed while outpatient), and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: (1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (phase I), (2) compare the preliminary efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (phase II), and (3) explore specific domains associated with improved outcomes, e.g., demographic, psychiatric, and drinking-related factors (phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time. Trial registration NCT#03493958; registered 1 June 2018

Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia

STUDY OBJECTIVES: The aim of this study was to test the efficacy of fully automated Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) 18 months after the intervention period on sleep, daytime functioning, and beliefs about sleep for adults with chronic insomnia. METHODS: Participants in this study had participated in a randomized controlled trial comparing the efficacy of unguided Internet CBT-I with web-based patient education. Participants who had received Internet CBT-I (n = 95) completed online questionnaires and online sleep diaries 18 months after the intervention period. We used linear mixed models to study changes from baseline to postassessment and to 18-month follow-up, and a separate mixed-models analysis to study changes from postassessment to 18-month follow-up. RESULTS: Mean age of the participants was 45.5 years (standard deviation = 12.6) and 64% were females. Sixty-six participants (70%) completed the 18-month follow-up assessment. There were significant improvements from baseline to 18-month follow-up on the Insomnia Severity Index (ISI) (Cohen d = 2.04 [95% confidence interval (CI) 1.66–2.42]) and the Bergen Insomnia Scale (BIS) (d = 1.64 [95% CI 1.30–1.98]), levels of daytime fatigue (d = 0.85 [95% CI 0.59–1.11]), psychological distress (d = 0.51 [95% CI 0.29–0.73]), and beliefs about sleep (d = 1.44 [95% CI 1.15–1.73]). Moderate to large effect size improvements were also shown on the diary-derived sleep variables. All improvements from baseline to postassessment were essentially maintained to 18-month follow-up. CONCLUSIONS: Unguided Internet CBT-I appears to have sustained effects on sleep, daytime functioning, and beliefs about sleep up to 18 months after the intervention period

Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia

STUDY OBJECTIVES: The aim of this study was to test the efficacy of fully automated Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) 18 months after the intervention period on sleep, daytime functioning, and beliefs about sleep for adults with chronic insomnia. METHODS: Participants in this study had participated in a randomized controlled trial comparing the efficacy of unguided Internet CBT-I with web-based patient education. Participants who had received Internet CBT-I (n = 95) completed online questionnaires and online sleep diaries 18 months after the intervention period. We used linear mixed models to study changes from baseline to postassessment and to 18-month follow-up, and a separate mixed-models analysis to study changes from postassessment to 18-month follow-up. RESULTS: Mean age of the participants was 45.5 years (standard deviation = 12.6) and 64% were females. Sixty-six participants (70%) completed the 18-month follow-up assessment. There were significant improvements from baseline to 18-month follow-up on the Insomnia Severity Index (ISI) (Cohen d = 2.04 [95% confidence interval (CI) 1.66–2.42]) and the Bergen Insomnia Scale (BIS) (d = 1.64 [95% CI 1.30–1.98]), levels of daytime fatigue (d = 0.85 [95% CI 0.59–1.11]), psychological distress (d = 0.51 [95% CI 0.29–0.73]), and beliefs about sleep (d = 1.44 [95% CI 1.15–1.73]). Moderate to large effect size improvements were also shown on the diary-derived sleep variables. All improvements from baseline to postassessment were essentially maintained to 18-month follow-up. CONCLUSIONS: Unguided Internet CBT-I appears to have sustained effects on sleep, daytime functioning, and beliefs about sleep up to 18 months after the intervention period