The GoodNight study—online CBT for insomnia for the indicated prevention of depression: study protocol for a randomised controlled trial

BACKGROUND Cognitive Behaviour Therapy for Insomnia (CBT-I) delivered through the Internet is effective as a treatment in reducing insomnia in individuals seeking help for insomnia. CBT-I also lowers levels of depression in this group. However, it is not known if targeting insomnia using CBT-I will lower depressive symptoms, and thus reduce the risk of major depressive episode onset, in those specifically at risk for depression. Therefore, this study aims to examine whether Internet delivery of fully automated self-help CBT-I designed to reduce insomnia will prevent depression. METHOD/DESIGN A sample of 1,600 community-dwelling adults (aged 18-64), who screen positive for both subclinical levels of depressive symptoms and insomnia, will be recruited via various media and randomised to either a 9-week online insomnia treatment programme, Sleep Healthy Using The internet (SHUTi), or an online attention-matched control group (HealthWatch). The primary outcome variable will be depression symptom levels at the 6-month post-intervention on the Patient Heath Questionnaire-9 (PHQ-9). A secondary outcome will be onset of major depressive episodes assessed at the 6-month post-intervention using 'current' and 'time from intervention' criteria from the Mini International Neuropsychiatric Interview. DISCUSSION This trial is the first randomised controlled trial of an Internet-based insomnia intervention as an indicated preventative programme for depression. If effective, online provision of a depression prevention programme will facilitate dissemination. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR), Registration number: ACTRN12611000121965.This study is supported by a grant from the National Health and Medical Research Council, Australia (GNT1005867)

Research priorities in mental health

Objective: Over the last decade, Australia has seen an increase in investment in mental health services, primarily through the funding of headspace and Better Access to Mental Health Outcomes programs. Concurrently there has been a policy focus on prevention and early intervention, suicide reduction and ‘hard-to-target’ groups such as Indigenous groups. It is not clear, however, whether research funding targeting health services or prevention or promotion has been prioritized, or whether funding priorities in general have shifted over the last decade. Methods: A total of 1008 Australian-authored research publications and 126 competitive research grants in 2008 were coded in terms of their target of research, research goal setting and target group. These characteristics were compared with the research priorities of 570 stakeholders, burden of disease estimates and similar data collected 10 years earlier. Results: The proportion of research funding for affective disorders, dementia and psychosis has increased, but not for anxiety disorders or suicide. Funding for childhood disorders has decreased. Funding for prevention and promotion is low and decreasing. With respect to research publications, substance abuse was associated with the most publications, followed by affective disorders, anxiety disorders and psychosis. When publications and funding are compared to stakeholder priorities and the burden of disease, the areas of suicide and self-harm, personality disorders, anxiety disorders, childhood conditions and dementia are all insufficiently funded. Conclusion: Despite mental health policy reforms through the last decade, there has been little change in the focus of research funding or publication output. There is modest evidence for a shift in support towards affective disorders as a major focus for research. However, the remaining gaps were very similar to those identified 10 years earlier showing that suicide, personality disorders and anxiety disorders are under-researched.This research was funded by the Mental Health Advisory Board of the Commonwealth Department of Health and Ageing

Prevention of Generalized Anxiety Disorder Using a Web Intervention, iChill: Randomized Controlled Trial

Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement.The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders.A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role.GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months, comprising 6.7% (11/165) from the Active groups (1, 2, 3) and 4.5% (5/110) from the Control groups (4, 5), a difference that was not significant. CES-D, ASI, and PSWQ scores were significantly lower for the active website with email reminders at post-test, relative to the control website condition.Indicated prevention of GAD was not effective in reducing anxiety levels, measured by GAD-7. There were significant secondary effects for anxiety sensitivity, worry, and depression. Challenges for indicated prevention trials are discussed.International Standard Randomized Controlled Trial Number (ISRCTN): 76298775; http://www.controlled-trials.com/ISRCTN76298775 (Archived by WebCite at http://www.webcitation.org/6S9aB5MAq)

The effectiveness of an online e-health application compared to attention placebo or Sertraline in the treatment of Generalised Anxiety Disorder

Background: Generalised Anxiety Disorder (GAD) is a high prevalence, chronic disorder that can be treated effectively through a number of web-based programs. However, online web programs for GAD have not been compared to standard pharmacological treatment. The present study compares an Internet Intervention (Active Website) for GAD and a selective serotonin re-uptake inhibitor (SSRI) (Sertraline), with an online attention placebo condition (Control Website). Objective: To evaluate the effectiveness of a web-based intervention for GAD in comparison to standard antidepressant medication and an online attention placebo condition over a 10. week period, and with a follow-up at 6 and at 12. months. Methods: The study was part of a larger scale prevention program. 152 people aged 18-30. years who met the criteria for GAD on the MINI received referrals to the treatment sub-study. The primary outcome was anxiety symptoms measured by the Generalised Anxiety Disorder 7-item Scale (GAD-7), and the secondary outcome was depression measured by the Center for Epidemiologic Studies Depression Scale (CES-D). Results: There was very poor uptake to the trial (around 14% of those referred). However, even in this small sample, Sertraline compared to the Control Website was significant at post-test and 6. months, and the Internet Intervention was significant at post-test. Relative to the Control Website condition at post-test, for the GAD-7 and CES-D respectively, the between group effect sizes were d=. 2.43 and d=. 0.68 for the Active Website condition, and 3.00 and 0.20 for the Sertraline condition. The within group effect size for the Control Website from baseline to post-test was -. 0.04 for the GAD-7 and 0.31 for CES-D respectively. Conclusions: The findings will need to be extended and confirmed in a larger trial. However, they do suggest that both standard pharmacological treatment and online interventions for GAD are effective in samples with a diagnosis of GAD recruited via online methods. The low rate of engagement for face-to-face treatment by those who opt first for a web program suggests that treatment preferences are important in help-seeking