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

Digital cognitive behaviour therapy for insomnia in individuals with self-reported insomnia and chronic fatigue: A secondary analysis of a large scale randomized controlled trial

Insomnia is associated with fatigue, but it is unclear whether response to cognitive behaviour therapy for insomnia is altered in individuals with co-occurring symptoms of insomnia and chronic fatigue. This is a secondary analysis using data from 1717 participants with self-reported insomnia in a community-based randomized controlled trial of digital cognitive behaviour therapy for insomnia compared with patient education. We employed baseline ratings of the Chalder Fatigue Questionnaire to identify participants with more or fewer symptoms of self-reported chronic fatigue (chronic fatigue, n = 592; no chronic fatigue, n = 1125). We used linear mixed models with Insomnia Severity Index, Short Form-12 mental health, Short Form-12 physical health, and the Hospital Anxiety and Depression Scale separately as outcome variables. The main covariates were main effects and interactions for time (baseline versus 9-week follow-up), intervention, and chronic fatigue. Participants with chronic fatigue reported significantly greater improvements following digital cognitive behaviour therapy for insomnia compared with patient education on the Insomnia Severity Index (Cohen's d = 1.36, p < 0.001), Short Form-12 mental health (Cohen's d = 0.19, p = 0.029), and Hospital Anxiety and Depression Scale (Cohen's d = 0.18, p = 0.010). There were no significant differences in the effectiveness of digital cognitive behaviour therapy for insomnia between chronic fatigue and no chronic fatigue participants on any outcome. We conclude that in a large community-based sample of adults with insomnia, co-occurring chronic fatigue did not moderate the effectiveness of digital cognitive behaviour therapy for insomnia on any of the tested outcomes. This may further establish digital cognitive behaviour therapy for insomnia as an adjunctive intervention in individuals with physical and mental disorders.publishedVersio

Dysfunctional beliefs and attitudes about sleep (DBAS) mediate outcomes in dCBT-I on psychological distress, fatigue, and insomnia severity

Objective/background Digital cognitive behavioral therapy for insomnia (dCBT-I) improves several sleep and health outcomes in individuals with insomnia. This study investigates whether changes in Dysfunctional Beliefs and Attitudes about Sleep (DBAS) during dCBT-I mediate changes in psychological distress, fatigue, and insomnia severity. Patients/methods The study presents a secondary planned analysis of data from 1073 participants in a randomized control trial (Total sample = 1721) of dCBT-I compared with patient education (PE). Self-ratings with the Dysfunctional Beliefs and Attitudes about Sleep (DBAS), the Hospital Anxiety Depression Scale (HADS), the Chalder Fatigue Scale (CFQ), and the Insomnia Severity Index (ISI) were obtained at baseline and 9-week follow-up. Hayes PROCESS mediation analyses were conducted to test for mediation. Results and conclusion sDBAS scores were significantly reduced at 9-week follow-up for those randomized to dCBT-I (n = 566) compared with PE (n = 507). The estimated mean difference was −1.49 (95% CI -1.66 to −1.31, p < .001, Cohen's d. = 0.93). DBAS mediated all the effect of dCBT-I on the HADS and the CFQ, and 64% of the change on the ISI (Estimated indirect effect −3.14, 95% CI -3.60 to −2.68) at 9-week follow-up compared with PE. Changes in the DBAS fully mediated the effects of dCBT-I on psychological distress and fatigue, and the DBAS partially mediated the effects on insomnia severity. These findings may have implications for understanding how dCBT-I works and highlights the role of changing cognitions in dCBT-I.publishedVersio

Is E-health Progressing Faster Than E-health Researchers?

Formal Internet interventions exist in a broad context of diverse online health resources, which share elements in common like information, advice and peer support. However, most online health resources are not created by healthcare professionals. Internet interventions need to be designed to “compete” in that wider context. The democratization of production and distribution is central to the transformative effect of the Internet on society, yet potentially conflicts with healthcare’s need for an evidence base and safe practice. This is a core challenge for healthcare on the Internet

Procedural Justice in the Context of Civil Commitment: A Critique of Tyler\u27s Analysis

This article is a critique of T. R. Tyler\u27s 1992 review of procedural justice and its effect on therapeutic outcome in patients involved in civil commitment hearings. The article clarifies critical elements of Tyler\u27s analysis by drawing on the social cognition construct of information control and elements in the consumerism literature that may mirror and facilitate procedural justice effects. The importance of the committing psychiatrist\u27s role during the commitment hearing is emphasized and issues unique to civil commitment respondents that might affect their susceptibility to procedural justice effects are highlighted. Further research examining the effects of judges\u27, attorneys\u27, and psychiatrists\u27 behavior on the patient\u27s perception of procedural justice and subsequent therapeutic outcome is suggested