Online insomnia treatment and the reduction of anxiety symptoms as a secondary outcome in a randomised controlled trial: The role of cognitive-behavioural factors.

OBJECTIVE: Insomnia and anxiety commonly co-occur, yet the mechanisms underlying this remain unclear. The current paper describes the impact of an Internet-based intervention for insomnia on anxiety, and explores the influence of two cognitive-behavioural constructs - dysfunctional beliefs about sleep and sleep-threat monitoring. METHODS: A large-scale, 9-week, two-arm randomised controlled trial ( N = 1149) of community-dwelling Australian adults with insomnia and elevated yet subclinical depression symptoms was conducted, comparing a cognitive behavioural therapy-based online intervention for insomnia (Sleep Healthy Using The Internet) with an attention-matched online control intervention (HealthWatch). Symptoms of anxiety were assessed at pretest, posttest, and 6-month follow-up. Dysfunctional beliefs about sleep and sleep threat monitoring were assessed only at pretest. RESULTS: Sleep Healthy Using The Internet led to a greater reduction in anxiety symptoms at both posttest ( t724.27 = -6.77, p < 0.001) and at 6-month follow-up ( t700.67 = -4.27, p < 0.001) than HealthWatch. At posttest and follow-up, this effect was found to moderated by sleep-threat monitoring ( t713.69 = -2.39, p < 0.05 and t694.77 = -2.98, p < 0.01 respectively) but not by dysfunctional beliefs about sleep at either posttest or follow-up ( t717.53 = -0.61, p = 0.55 and t683.79 = 0.22, p = 0.83 respectively). Participants in the Sleep Healthy Using The Internet condition with higher levels of sleep-threat monitoring showed a greater reduction in anxiety than those with lower levels from pretest to posttest, ( t724.27 = -6.77, p < 0.001) and through to 6-month follow-up ( t700.67 = -4.27, p < 0.001). This result remained after controlling for baseline anxiety levels. CONCLUSION: The findings suggest that online cognitive behavioral therapy interventions for insomnia are beneficial for reducing anxiety regardless of people's beliefs about their sleep and insomnia, and this is particularly the case for those with high sleep-threat monitoring. This study also provides further evidence for cognitive models of insomnia.

The Beyond Ageing Project Phase 2--a double-blind, selective prevention, randomised, placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression: study protocol for a randomized controlled trial.

BACKGROUND: Late-life depression is associated with high rates of morbidity, premature mortality, disability, functional decline, caregiver burden and increased health care costs. While clinical and public health approaches are focused on prevention or early intervention strategies, the ideal method of intervention remains unclear. No study has set out to evaluate the role of neurobiological agents in preventing depressive symptoms in older populations at risk of depression. METHODS/DESIGN: Subjects with previously reported sub-threshold depressive symptoms, aged 60 to 74 years, will be screened to participate in a single-centre, double-blind, randomised controlled trial with three parallel groups involving omega-3 fatty acid supplementation or sertraline hydrochloride, compared with matching placebo. Subjects will be excluded if they have current depression or suicide ideation; are taking antidepressants or any supplement containing omega-3 fatty acid; or have a prior history of stroke or other serious cerebrovascular or cardiovascular disease, neurological disease, significant psychiatric disease (other than depression) or neurodegenerative disease. The trial will consist of a 12 month treatment phase with follow-up at three months and 12 months to assess outcome events. At three months, subjects will undergo structural neuroimaging to assess whether treatment effects on depressive symptoms correlate with brain changes. Additionally, proton spectroscopy techniques will be used to capture brain-imaging markers of the biological effects of the interventions. The trial will be conducted in urban New South Wales, Australia, and will recruit a community-based sample of 450 adults. Using intention-to-treat methods, the primary endpoint is an absence of clinically relevant depression scores at 12 months between the omega-3 fatty acid and sertraline interventions and the placebo condition. DISCUSSION: The current health, social and economic costs of late-life depression make prevention imperative from a public health perspective. This innovative trial aims to address the long-neglected area of prevention of depression in older adults. The interventions are targeted to the pathophysiology of disease, and regardless of the effect size of treatment, the outcomes will offer major scientific advances regarding the neurobiological action of these agents. The main results are expected to be available in 2017. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000032055 (12 January 2010).

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 .

Australian mental health consumers' priorities for research: qualitative findings from the SCOPE for Research project.

BACKGROUND: There is growing acceptance of the importance of the consumer viewpoint in mental health research. Previous studies have identified differences in research priorities between researchers and mental health consumers in Australia defined broadly. However, little is known about the research priorities of consumers with specific mental health conditions. OBJECTIVE: The aim of this study was to explore Australian mental health consumers' priorities for depression and bipolar disorder research. DESIGN: Focus groups with consumers and individual telephone interviews with consumer advocates. Participants were asked to discuss the topics they believed were priorities for depression or bipolar disorder research. Transcripts were thematically analysed using NVivo 7. SETTING AND PARTICIPANTS: Ten people with depression and 19 with bipolar disorder participated in face-to-face focus groups held in three Australian capital cities. Five participants with each disorder participated in online focus groups. Five Australian consumer advocates with experience of depression and six with experience of bipolar disorder were individually interviewed by telephone. RESULTS: Participants raised a broad variety of topics for research. The most salient themes included the need for research on medication, and lifestyle and psychosocial influences on depression and bipolar disorder. CONCLUSIONS: Participants' priorities reflect an interest in a holistic approach to mental health research that examines the influences of everyday life and psychosocial influences both on the development and on the management of these disorders. Their focus was on research that explores individualized care and the active role that consumers can play in their own care and recovery.

SCOPE for Research: mental health consumers' priorities for research compared with recent research in Australia.

OBJECTIVE: The aim of this study was to identify consumer priorities for research on depression and bipolar disorder in Australia. METHOD: Australian consumers with personal experience of depression or bipolar disorder were surveyed online about research priorities for their condition using a questionnaire developed from an earlier qualitative phase of the SCOPE for Research project. Participants were asked to rate the importance of a number of broad research areas, specific research topics, target groups and settings in which to conduct research. These ratings were then compared to the content of relevant Australian research published between 1997 and 2006. RESULTS: Consumers rated research into the management and treatment of depression and bipolar disorder of highest priority. Further, consumers rated those at risk of a mood disorder as the most important target groups for research and prioritized research conducted in health settings such as community mental health services ahead of research in other settings. There was some concordance between consumers' ratings of the broad topic areas and settings in which to conduct research and the amount of published research on these topic areas and settings. However, there was little published research on the highest ranked consumer-rated specific topics and target groups for research. CONCLUSIONS: Overall, there were substantial differences between the priorities of consumers and the recent research output, suggesting gaps in the Australian research base on mood disorders. The results of this study should be used to inform future research to ensure that it is guided by the priorities of the ultimate beneficiaries of the research, mental health consumers.

Directions for the International Society for Research on Internet Interventions (ISRII).

In 2004, the International Society for Research on Internet Interventions (ISRII) was formed to encourage eHealth researchers to collaborate in their efforts to further the science behind developing, testing, and disseminating Web-based treatment programs. The group held its second meeting (April 2006) to clarify the Society's direction and identify key issues that need addressing in the field. These issues are identified and examined in the current paper. Given the success of using the Internet to treat a range of medical and mental health problems, and the growing need for better dissemination of health care, Internet interventions will almost certainly play a prominent role in global health. ISRII plans to provide the necessary venue to ensure the science driving this field is strong, enabling researchers to conduct the highest quality research and permitting meaningful conclusions from completed studies.