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A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study.

ABSTRACT: BACKGROUND:Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18?years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implementing and accessing these programmes remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programmes. The Future Proofing Study is a large-scale school-based trial investigating whether cognitive behaviour therapies (CBT) delivered by smartphone application can prevent depression. METHODS:A randomised controlled trial targeting up to 10,000?Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression, and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur post intervention (both trial stages) and at 6, 12, 24, 36, 48 and 60 months post baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed-effect models. DISCUSSION:This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much-needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programmes should be deployed in school-based settings in Australia and beyond. TRIAL REGISTRATION:Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

SUBMITTER: Werner-Seidler A

PROVIDER: S-EPMC6941300 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study.

Werner-Seidler Aliza A Huckvale Kit K Larsen Mark E ME Calear Alison L AL Maston Kate K Johnston Lara L Torok Michelle M O'Dea Bridianne B Batterham Philip J PJ Schweizer Susanne S Skinner S Rachel SR Steinbeck Katharine K Ratcliffe Julie J Oei Ju-Lee JL Patton George G Wong Iana I Beames Joanne J Wong Quincy J J QJJ Lingam Raghu R Boydell Katherine K Salmon Allison M AM Cockayne Nicole N Mackinnon Andrew A Christensen Helen H

Trials 20200102 1

<h4>Background</h4>Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implem ...[more]

PMID: 31898512

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Project description:IntroductionProcess evaluations provide insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a cluster randomised trial of a digital depression prevention intervention delivered to secondary school students (the Future Proofing Study). The purpose is to describe the methods that will be used to capture process evaluation data within this trial.Methods and analysisUsing a hybrid type 1 design, a mixed-methods approach will be used with data collected in the intervention arm of the Future Proofing Study. Data collection methods will include semistructured interviews with school staff and study facilitators, automatically collected intervention usage data and participant questionnaires (completed by school staff, school counsellors, study facilitators and students). Information will be collected about: (1) how the intervention was implemented in schools, including fidelity; (2) school contextual factors and their association with intervention reach, uptake and acceptability; (3) how school staff, study facilitators and students responded to delivering or completing the intervention. How these factors relate to trial effectiveness outcomes will also be assessed. Overall synthesis of the data will provide school cluster-level and individual-level process outcomes.Ethics and disseminationEthics approval was obtained from the University of New South Wales (NSW) Human Research Ethics Committee (HC180836; 21st January 2019) and the NSW Government State Education Research Applications Process (SERAP 2019201; 19th August 2019). Results will be submitted for publication in peer-reviewed journals and discussed at conferences. Our process evaluation will contextualise the trial findings with respect to how the intervention may have worked in some schools but not in others. This evaluation will inform the development of a model for rolling out digital interventions for the prevention of mental illness in schools.Trial registration numberANZCTRN12619000855123; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377664&isReview=true.

Project description:BackgroundAlcohol consumption in pregnancy has been associated with serious fetal health risks and maternal complications. While previous systematic reviews of digital interventions during pregnancy have targeted smoking cessation and flu vaccine uptake, few studies have sought to evaluate their effectiveness in preventing alcohol consumption during pregnancy.ObjectiveThis systematic review aims to assess (1) whether digital interventions are effective in preventing alcohol consumption during the pregnancy/pregnancy-planning period, and (2) the differential effectiveness of alternative digital intervention platforms (ie, computers, mobiles, and text messaging services).MethodsPubMed, Embase, CINAHL, and Web of Science were searched for studies with digital interventions aiming to prevent alcohol consumption among pregnant women or women planning to become pregnant. A random effects primary meta-analysis was conducted to estimate the combined effect size and extent to which different digital platforms were successful in preventing alcohol consumption in pregnancy.ResultsSix studies were identified and included in the final review. The primary meta-analysis produced a sample-weighted odds ratio (OR) of 0.62 (95% CI 0.42-0.91; P=.02) in favor of digital interventions decreasing the risk of alcohol consumption during pregnancy when compared to controls. Computer/internet-based interventions (OR 0.59, 95% CI 0.38-0.93) were an effective platform for preventing alcohol consumption. Too few studies of text messaging (OR 0.29, 95% CI 0.29-2.52) were available to draw a conclusion.ConclusionsOverall, our review highlights the potential for digital interventions to prevent alcohol consumption among pregnant women and women planning to become pregnant. Considering the advantages of digital interventions in promoting healthy behavioral changes, future research is necessary to understand how certain platforms may increase user engagement and intervention effectiveness to prevent women from consuming alcohol during their pregnancies.

Project description:BackgroundDepression and anxiety are common mental health disorders worldwide. The UK's Improving Access to Psychological Therapies (IAPT) programme is part of the National Health Service (NHS) designed to provide a stepped care approach to treating people with anxiety and depressive disorders. Cognitive Behavioural Therapy (CBT) is widely used, with computerised and internet-delivered cognitive behavioural therapy (cCBT and iCBT, respectively) being a suitable IAPT approved treatment alternative for step 2, low- intensity treatment. iCBT has accumulated a large empirical base for treating depression and anxiety disorders. However, the cost-effectiveness and impact of these interventions in the longer-term is not routinely assessed by IAPT services. The current study aims to evaluate the clinical and cost-effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT.MethodsThe study is a parallel-groups, randomised controlled trial examining the effectiveness and cost-effectiveness of iCBT interventions for depression and anxiety disorders, against a waitlist control group. The iCBT treatments are of 8 weeks duration and will be supported by regular post-session feedback by Psychological Wellbeing Practitioners. Assessments will be conducted at baseline, during, and at the end of the 8-week treatment and at 3, 6, 9, and 12-month follow-up. A diagnostic interview will be employed at baseline and 3-month follow-up. Participants in the waitlist control group will complete measures at baseline and week 8, at which point they will receive access to the treatment. All adult users of the Berkshire NHS Trust IAPT Talking Therapies Step 2 services will be approached to participate and measured against set eligibility criteria. Primary outcome measures will assess anxiety and depressive symptoms using the GAD-7 and PHQ-9, respectively. Secondary outcome measures will allow for the evaluation of long-term outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment. Analysis will be conducted on a per protocol and intention-to-treat basis.DiscussionThis study seeks to evaluate the immediate and longer-term impact, as well as the cost effectiveness of internet-delivered interventions for depression and anxiety. This study will contribute to the already established literature on internet-delivered interventions worldwide. The study has the potential to show how iCBT can enhance service provision, and the findings will likely be generalisable to other health services.Trial registrationCurrent Controlled Trials ISRCTN ISRCTN91967124. DOI: https://doi.org/10.1186/ISRCTN91967124 . Web: http://www.isrctn.com/ISRCTN91967124 . Clinicaltrials.gov : NCT03188575. Trial registration date: June 8, 2017 (prospectively registered).

Project description:BackgroundDepression is a serious mental health problem and is common in children and adolescents. Online interventions are promising in overcoming the widespread undertreatment of depression and in improving the help-seeking behavior in children and adolescents.MethodsThe multicentre, randomized controlled E.motion trial is part of the German ProHEAD consortium (Promoting Help-seeking using E-technology for ADolescents). The objective of the trial is to investigate the efficacy and cost-effectiveness of two online interventions to reduce depressive symptomatology in high-risk children and adolescents with subsyndromal symptoms of depression in comparison to an active control group. Participants will be randomized to one of three conditions: (1) Intervention 1, a clinician-guided self-management program (iFightDepression®); (2) Intervention 2, a clinician-guided group chat intervention; and (3) Control intervention, a psycho-educational website on depressive symptoms. Interventions last six weeks. In total, N = 363 children and adolescents aged ≥ 12 years with Patient Health Questionnaire-9 modified for Adolescents (PHQ-A) scores in the range of 5-9 will be recruited at five study sites across Germany. Online questionnaires will be administered before onset of the intervention, at the end of the intervention, and at the six-month follow-up. Further, children and adolescents will participate in the baseline screening and the one- and two-year school-based follow-up assessments integrated in the ProHEAD consortium. The primary endpoint is depression symptomatology at the end of intervention as measured by the PHQ-A score. Secondary outcomes include depression symptomatology at all follow-ups, help-seeking attitudes, and actual face-to-face help-seeking, adherence to and satisfaction with the interventions, depression stigma, and utilization and cost of interventions.DiscussionThis study represents the first randomized controlled trial (RCT) investigating efficacy and cost-effectiveness of two online interventions in children and adolescents aged ≥ 12 years at risk for depression. It aims to provide a better understanding of the help-seeking behavior of children and adolescents, potential benefits of E-mental health interventions for this age group, and new insights into so far understudied aspects of E-mental health programs, such as potential negative effects of online interventions. This knowledge will be used to tailor and improve future help offers and programs for children and adolescents and ways of treatment allocation.Trial registrationGerman Register for Clinical Trials (DRKS), DRKS00014668 . Registered on 4 May 2018. International trial registration took place through the "international clinical trials registry platform" with the secondary ID S-086/2018.

Project description:BackgroundThere is a high prevalence of older adults experiencing depression and anxiety. In response to heightened demands for mental health interventions that are accessible and affordable, there has been a recent rise in the number of digital mental health interventions (DMHIs) that have been developed and incorporated into mental health treatments. Digital interventions are promising in their ability to provide researchers, medical practitioners, and patients with personalized tools for assessing behavior, consultation, treatment, and care that can be used remotely. Reviews and meta-analyses have shown the benefits of DMHIs for the treatment and prevention of depression, anxiety, and other mental illnesses, but there is still a lack of studies that focus on the benefits and use of DMHIs in the older population.ObjectiveThe aim of this systematic review is to investigate the current evidence for the effect of technology-delivered interventions, such as smartphone/tablet applications, remote monitoring and tracking devices, and wearable technology, for the treatment and prevention of depression and anxiety in adults older than 50 years.MethodsThe academic databases SCOPUS, PsycINFO, AgeLine (EBSCO), and Medline (PubMed) will be searched from January 1, 2010, to the date of search commencement to provide a review of existing randomized controlled trial studies. The search will include 3 key concepts: "older adults," "digital intervention," and "depression/anxiety." A set of inclusion criteria will be followed during screening by two reviewers. Data will be extracted to address aims and objectives of the review. The risk of bias for each study will be determined using appropriate tools. If possible, a random-effects meta-analysis will be performed, and the heterogeneity of effect sizes will be calculated.ResultsPreliminary searches were conducted in September 2020. The review is anticipated to be completed by April 2021.ConclusionsThe data accumulated in this systematic review will demonstrate the potential benefits of technology-delivered interventions for the treatment of depression and anxiety disorders in older adults. This review will also identify any gaps in current studies of aging and mental health interventions, thereby navigating a way to move forward and paving the path to more accessible and user-friendly digital health interventions for the diverse population of older adults.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020192532; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020192532.International registered report identifier (irrid)PRR1-10.2196/22738.

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A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study.

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A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study.

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