Search

BackgroundRandomized controlled trials (RCTs) with vigorous study designs are vital for determining the efficacy of treatments. Despite the high internal validity attributed to RCTs, external validity concerns limit the generalizability of results to the general population. Bias can be introduced, for example, when study participants who self-select into a trial are more motivated to comply with study conditions than are other individuals. These external validity considerations extend to e-mental health (eMH) research, especially when eMH tools are designed for public access and provide minimal or no supervision. ObjectiveClustering techniques were employed to identify engagement profiles of RCT participants and community users of a self-guided eMH program. This exploratory approach inspected actual, not theorized, RCT participant and community user engagement patterns. Both samples had access to the eMH program over the same time period and received identical usage recommendations on the eMH program website. The aim of this study is to help gauge expectations of similarities and differences in usage behaviors of an eMH tool across evaluation and naturalistic contexts. MethodsAustralian adults signed up to myCompass, a self-guided online treatment program created to reduce mild to moderate symptoms of negative emotions. They did so either by being part of an RCT onboarding (160/231, 69.6% female) or by accessing the program freely on the internet (5563/8391, 66.30% female) between October 2011 and October 2012. During registration, RCT participants and community users provided basic demographic information. Usage metrics (number of logins, trackings, and learning activities) were recorded by the system. ResultsSamples at sign-up differed significantly in age (P=.003), with community users being on average 3 years older (mean 41.78, SD 13.64) than RCT participants (mean 38.79, SD 10.73). Furthermore, frequency of program use was higher for RCT participants on all usage metrics compared to community users through the first 49 days after registration (all P values

BackgroundPeople with type 2 diabetes mellitus (T2DM) often experience mental health symptoms that exacerbate illness and increase mortality risk. Access to psychological support is low in people with T2DM. Detection of depression is variable in primary care and can be further hampered by mental health stigma. Electronic mental health (eMH) programs may provide an accessible, private, nonstigmatizing mental health solution for this group. ObjectiveThis study aims to evaluate the efficacy over 12 months of follow-up of an eMH program (myCompass) for improving social and occupational functioning in a community sample of people with T2DM and self-reported mild-to-moderate depressive symptoms. myCompass is a fully automated and self-guided web-based public health program for people with depression or anxiety. The effects of myCompass on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior were also examined. MethodsAdults with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited via online advertisements, community organizations, and general practices. Screening, consent, and self-report questionnaires were administered online. Eligible participants were randomized to receive either myCompass (n=391) or an attention control generic health literacy program (Healthy Lifestyles; n=379) for 8 weeks. At baseline and at 3, 6, and 12 months postintervention, participants completed the Work and Social Adjustment Scale, the Patient Health Questionnaire-9 item, the Diabetes Distress Scale, the Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. Glycosylated hemoglobin measurements were obtained at baseline and 6 and 12 months postintervention. ResultsA total of 38.9% (304/780) of the trial participants completed all postintervention assessments. myCompass users logged in on an average of 6 times and completed an average of 0.29 modules. Healthy Lifestyles users logged in on an average of 4 times and completed an average of 1.37 modules. At baseline, the mean scores on several outcome measures, including the primary outcome of work and social functioning, were close to the normal range, despite a varied and extensive recruitment process. Intention-to-treat analyses revealed slightly greater improvement at 12 months in work and social functioning for the Healthy Lifestyles group relative to the myCompass group. All participants reported equivalent improvements in depression anxiety, diabetes distress, diabetes self-management, and glycemic control across the trial. ConclusionsThe Healthy Lifestyles group reported higher ratings of social and occupational functioning than the myCompass group, but no differences were observed for any secondary outcome. Although these findings should be interpreted in light of the near-floor symptom scores at baseline, the trial yields important insights into how people with T2DM might be engaged in eMH programs and the challenges of focusing specifically on mental health. Several avenues emerge for continued investigation into how best to deal with the growing mental health burden in adults with T2DM. Trial RegistrationAustralian New Zealand Clinical Trials Registry Number (ACTRN) 12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true

BackgroundSelf-help smartphone apps offer a new opportunity to address youth suicide prevention by improving access to support and by providing potentially high fidelity and cost-effective treatment. However, there have been very few smartphone apps providing evidence-based support for suicide prevention in this population. To address this gap, we developed the LifeBuoy app, a self-help smartphone app informed by dialectical behavior therapy (DBT), to help young people manage suicidal thoughts in their daily life. ObjectiveThis study describes the protocol for a randomized controlled trial to evaluate the efficacy of the LifeBuoy app for reducing suicidal thoughts and behaviors, depression, anxiety, and psychological distress, and improving general mental well-being in young adults aged 18 to 25 years. MethodsThis is a randomized controlled trial recruiting 378 young adults aged between 18 and 25 years and comparing the LifeBuoy app with a matched attention control (a placebo app with the same display but no DBT components). The primary outcome is suicidal thoughts measured by the Suicidal Ideation Attributes Scale (SIDAS). The secondary outcomes are suicidal behavior, depression, anxiety, psychological distress, and general mental well-being. The changes in the levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking before and after using the app are evaluated in this study. The study also addresses risk factors and responses to the intervention. A series of items assessing COVID-19 experiences is included in the trial to capture the potential impact of the pandemic on this study. Assessments will occur on the following three occasions: baseline, postintervention, and follow-up at 3 months postintervention. A qualitative interview about user experience with the LifeBuoy app will take place within 4 weeks of the final assessment. Using linear mixed models, the primary analysis will compare the changes in suicidal thoughts in the intervention condition relative to the control condition. To minimize risks, participants will receive a call from the team clinical psychologist by clicking a help button in the app or responding to an automated email sent by the system when they are assessed with elevated suicide risks at the baseline, postintervention, and 3-month follow-up surveys. ResultsThe trial recruitment started in May 2020. Data collection is currently ongoing. ConclusionsThis is the first trial examining the efficacy of a DBT-informed smartphone app delivered to community-living young adults reporting suicidal thoughts. This trial will extend knowledge about the efficacy and acceptability of app-based support for suicidal thoughts in young people. Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12619001671156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378366. International Registered Report Identifier (IRRID)PRR1-10.2196/23655

In this viewpoint we describe the architecture of, and design rationale for, a new software platform designed to support the conduct of digital phenotyping research studies. These studies seek to collect passive and active sensor signals from participants' smartphones for the purposes of modelling and predicting health outcomes, with a specific focus on mental health. We also highlight features of the current research landscape that recommend the coordinated development of such platforms, including the significant technical and resource costs of development, and we identify specific considerations relevant to the design of platforms for digital phenotyping. In addition, we describe trade-offs relating to data quality and completeness versus the experience for patients and public users who consent to their devices being used to collect data. We summarize distinctive features of the resulting platform, InSTIL (Intelligent Sensing to Inform and Learn), which includes universal (ie, cross-platform) support for both iOS and Android devices and privacy-preserving mechanisms which, by default, collect only anonymized participant data. We conclude with a discussion of recommendations for future work arising from learning during the development of the platform. The development of the InSTIL platform is a key step towards our research vision of a population-scale, international, digital phenotyping bank. With suitable adoption, the platform will aggregate signals from large numbers of participants and large numbers of research studies to support modelling and machine learning analyses focused on the prediction of mental illness onset and disease trajectories.

BackgroundAdolescence can be a fertile time for relationship issues, with interpersonal conflict being a risk factor for poor mental health. Mobile app interventions may have a significant appeal to young people in assisting with relationship distress. However, currently available apps have not been formally evaluated. Youths’ perspectives on engaging with mobile technology to assist with relationships are also unknown. ObjectiveThis study aimed to examine adolescents’ attitudes toward the concept of a mobile phone app for relationship help and support, and whether they would be likely to use such an intervention. MethodsA cross-sectional Web survey consisting of 42 questions, including 13 free responses, was delivered. The proposed app, including character vignettes, was presented, and participants were asked to indicate whether they had experienced the same relationship issues, whether their peers would relate to the issues, and how helpful they found the proposed advice. Participants were also asked to provide their own suggestions for help, which were analyzed using thematic analyses. ResultsA total of 150 adolescents (aged 15 to 18) participated. Overall, 60.7% (91/150) were likely to use an app for relationship problems, and this was not associated with demographics or social support (all P values >.05). Likelihood of app usage was found to be influenced by perceived need for help, personal beliefs about app effectiveness, and whether the app is engaging and easy to use. Overall, adolescents were receptive of the proposed content with an average of 99.3% (149/150), rating the strategies provided as somewhat to very helpful. ConclusionsAdolescents were likely to use a mobile phone app for relationship support, and use was not influenced by gender, age, social support, or any other background characteristic. Instead, likely use was influenced by need, personal beliefs, usability, and the appropriateness of app content. App developers must address these factors if the app is to have a wide-scale uptake.

BackgroundFor many mental health conditions, mobile health apps offer the ability to deliver information, support, and intervention outside the clinical setting. However, there are difficulties with the use of a commercial app store to distribute health care resources, including turnover of apps, irrelevance of apps, and discordance with evidence-based practice. ObjectiveThe primary aim of this study was to quantify the longevity and rate of turnover of mental health apps within the official Android and iOS app stores. The secondary aim was to quantify the proportion of apps that were clinically relevant and assess whether the longevity of these apps differed from clinically nonrelevant apps. The tertiary aim was to establish the proportion of clinically relevant apps that included claims of clinical effectiveness. We performed additional subgroup analyses using additional data from the app stores, including search result ranking, user ratings, and number of downloads. MethodsWe searched iTunes (iOS) and the Google Play (Android) app stores each day over a 9-month period for apps related to depression, bipolar disorder, and suicide. We performed additional app-specific searches if an app no longer appeared within the main search ResultsOn the Android platform, 50% of the search results changed after 130 days (depression), 195 days (bipolar disorder), and 115 days (suicide). Search results were more stable on the iOS platform, with 50% of the search results remaining at the end of the study period. Approximately 75% of Android and 90% of iOS apps were still available to download at the end of the study. We identified only 35.3% (347/982) of apps as being clinically relevant for depression, of which 9 (2.6%) claimed clinical effectiveness. Only 3 included a full citation to a published study. ConclusionsThe mental health app environment is volatile, with a clinically relevant app for depression becoming unavailable to download every 2.9 days. This poses challenges for consumers and clinicians seeking relevant and long-term apps, as well as for researchers seeking to evaluate the evidence base for publicly available apps.

BackgroundThe economic cost of depression is becoming an ever more important determinant for health policy and decision makers. Internet-based interventions with and without therapist support have been found to be effective options for the treatment of mild to moderate depression. With increasing demands on health resources and shortages of mental health care professionals, the integration of cost-effective treatment options such as Internet-based programs into primary health care could increase efficiency in terms of resource use and costs. ObjectiveOur aim was to evaluate the cost-effectiveness of an Internet-based intervention (myCompass) for the treatment of mild-to-moderate depression compared to treatment as usual and cognitive behavior therapy in a stepped care model. MethodsA decision model was constructed using a cost utility framework to show both costs and health outcomes. In accordance with current treatment guidelines, a stepped care model included myCompass as the first low-intervention step in care for a proportion of the model cohort, with participants beginning from a low-intensity intervention to increasing levels of treatment. Model parameters were based on data from the recent randomized controlled trial of myCompass, which showed that the intervention reduced symptoms of depression, anxiety, and stress and improved work and social functioning for people with symptoms in the mild-to-moderate range. ResultsThe average net monetary benefit (NMB) was calculated, identifying myCompass as the strategy with the highest net benefit. The mean incremental NMB per individual for the myCompass group was AUD 1165.88 compared to treatment as usual and AUD 522.58 for the cognitive behavioral therapy model. ConclusionsInternet-based interventions can provide cost-effective access to treatment when provided as part of a stepped care model. Widespread dissemination of Internet-based programs can potentially reduce demands on primary and tertiary services and reduce unmet need.

BackgroundThe use of amphetamine-type stimulants (ATS) places a large burden on health services. ObjectiveThe aim was to evaluate the effectiveness of a self-guided Web-based intervention (“breakingtheice”) for ATS users over 6 months via a free-to-access site. MethodsWe conducted a randomized trial comparing a waitlist control with a fully automated intervention containing 3 modules derived from cognitive behavioral therapy and motivation enhancement. The main outcome was self-reported ATS use in the past 3 months assessed at 3- and 6-month follow-ups using the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Secondary outcomes were help-seeking intentions (general help-seeking questionnaire), actual help seeking (actual help-seeking questionnaire), psychological distress (Kessler 10), polydrug use (ASSIST), quality of life (European Health Interview Survey), days out of role, and readiness to change. Follow-up data were evaluated using an intention-to-treat (ITT) analysis with a group by time interaction. ResultsWe randomized 160 people (intervention: n=81; control: n=79). At 6 months, 38 of 81 (47%) intervention and 41 of 79 (52%) control participants provided data. ATS scores significantly declined for both groups, but the interaction effect was not significant. There were significant ITT time by group interactions for actual help seeking (rate ratio [RR] 2.16; d=0.45) and help-seeking intentions (RR 1.17; d=0.32), with help seeking increasing for the intervention group and declining for the control group. There were also significant interactions for days completely (RR 0.50) and partially (RR 0.74) out of role favoring the intervention group. However, 37% (30/81) of the intervention group did not complete even 1 module. ConclusionsThis self-guided Web-based intervention encouraged help seeking associated with ATS use and reduced days out of role, but it did not reduce ATS use. Thus, this program provides a means of engaging with some sections of a difficult-to-reach group to encourage treatment, but a substantial minority remained disengaged. Trial RegistrationAustralian and New Zealand Clinical Trials Registry: ACTRN12611000947909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343307 (Archived by WebCite at http://www.webcitation.org/6Y0PGGp8q).

BackgroundE-therapies for depression and anxiety rarely account for lesbian and gay users. This is despite lesbians and gay men being at heightened risk of mood disorders and likely to benefit from having access to tailored self-help resources. ObjectiveWe sought to determine how e-therapies for depression and anxiety could be improved to address the therapeutic needs of lesbians and gay men. MethodsWe conducted eight focus groups with lesbians and gay men aged 18 years and older. Focus groups were presented with key modules from the popular e-therapy “MoodGYM”. They were asked to evaluate the inclusiveness and relevance of these modules for lesbians and gay men and to think about ways that e-therapies in general could be modified. The focus groups were analyzed qualitatively using a thematic analysis approach to identify major themes. ResultsThe focus groups indicated that some but not all aspects of MoodGYM were suitable, and suggested ways of improving e-therapies for lesbian and gay users. Suggestions included avoiding language or examples that assumed or implied users were heterosexual, improving inclusiveness by representing non-heterosexual relationships, providing referrals to specialized support services and addressing stigma-related stress, such as “coming out” and experiences of discrimination and harassment. Focus group participants suggested that dedicated e-therapies for lesbians and gay men should be developed or general e-therapies be made more inclusive by using adaptive logic to deliver content appropriate for a user’s sexual identity. ConclusionsFindings from this study offer in-depth guidance for developing e-therapies that more effectively address mental health problems among lesbians and gay men.

BackgroundGeneralized 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. ObjectiveThe 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. MethodsA 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. ResultsGAD-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. ConclusionsIndicated 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. Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 76298775; http://www.controlled-trials.com/ISRCTN76298775 (Archived by WebCite at http://www.webcitation.org/6S9aB5MAq).

BackgroundAmong illicit drugs, the prevalence of amphetamine-type stimulant (ATS) use is second only to cannabis. Currently, there are no approved pharmacotherapies for ATS problems, but some face-to-face psychotherapies are effective. Web-based interventions have proven to be effective for some substance use problems, but none has specifically targeted ATS users. ObjectiveThe objective of the study was to evaluate the effectiveness of a Web-based intervention for ATS problems on a free-to-access site compared with a waitlist control group. MethodsWe used a randomized controlled trial design. The primary outcome measure was self-reported ATS use in the past three months assessed using the Alcohol, Smoking, Substance Involvement Screening Test (ASSIST). Other measures included quality of life (EUROHIS score), psychological distress (K-10 score), days out of role, poly-drug use, general help-seeking intentions, actual help-seeking, and “readiness to change”. The intervention consisted of three fully automated, self-guided modules based on cognitive behavioral therapy and motivation enhancement. The analysis was an intention-to-treat analysis using generalized estimating equation models, with a group by time interaction as the critical assessment. ResultsWe randomized 160 people (intervention n=81, control n=79). At three months, 35/81 (43%) intervention and 45/79 (57%) control participants provided follow-up data. In the intervention group, 51/81 (63%) completed at least one module. The only significant group by time interaction was for days out of role. The pre/post change effect sizes showed small changes (range d=0.14 to 0.40) favoring the intervention group for poly-drug use, distress, actual help-seeking, and days out of role. In contrast, the control group was favored by reductions in ATS use, improvements in quality of life, and increases in help-seeking intentions (range d=0.09 to 0.16). ConclusionsThis Web-based intervention for ATS use produced few significant changes in outcome measures. There were moderate, but nonsignificant reductions in poly-drug use, distress, days partially out of role, and increases in help-seeking. However, high levels of participant attrition, plus low levels of engagement with the modules, preclude firm conclusions being drawn on the efficacy of the intervention and emphasize the problems of engaging this group of clients in a fully automated program. Trial RegistrationAustralian and New Zealand Clinical Trials Registry: ACTRN 12611000947909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000947909 (Archived by WebCite at http://www.webcitation.org/6SHTxEnzP).

BackgroundLesbians and gay men have disproportionately high rates of depression and anxiety, and report lower satisfaction with treatments. In part, this may be because many health care options marginalize them by assuming heterosexuality, or misunderstand and fail to respond to the challenges specifically faced by these groups. E-therapies have particular potential to respond to the mental health needs of lesbians and gay men, but there is little research to determine whether they do so, or how they might be improved. ObjectiveWe sought to examine the applicability of existing mental health e-therapies for lesbians and gay men. MethodsWe reviewed 24 Web- and mobile phone-based e-therapies and assessed their performance in eight key areas, including the use of inclusive language and content and whether they addressed mental health stressors for lesbians and gay men, such as experiences of stigma related to their sexual orientation, coming out, and relationship issues that are specific to lesbians and gay men. ResultsWe found that e-therapies seldom addressed these stressors. Furthermore, 58% (14/24) of therapies contained instances that assumed or suggested the user was heterosexual, with instances especially prevalent among better-evidenced programs. ConclusionsOur findings, and a detailed review protocol presented in this article, may be used as guides for the future development of mental health e-therapies to better accommodate the needs of lesbians and gay men.

BackgroundThe rapid growth in the use of mobile phone applications (apps) provides the opportunity to increase access to evidence-based mental health care. ObjectiveOur goal was to systematically review the research evidence supporting the efficacy of mental health apps for mobile devices (such as smartphones and tablets) for all ages. MethodsA comprehensive literature search (2008-2013) in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, PsycINFO, PsycTESTS, Compendex, and Inspec was conducted. We included trials that examined the effects of mental health apps (for depression, anxiety, substance use, sleep disturbances, suicidal behavior, self-harm, psychotic disorders, eating disorders, stress, and gambling) delivered on mobile devices with a pre- to posttest design or compared with a control group. The control group could consist of wait list, treatment-as-usual, or another recognized treatment. ResultsIn total, 5464 abstracts were identified. Of those, 8 papers describing 5 apps targeting depression, anxiety, and substance abuse met the inclusion criteria. Four apps provided support from a mental health professional. Results showed significant reductions in depression, stress, and substance use. Within-group and between-group intention-to-treat effect sizes ranged from 0.29-2.28 and 0.01-0.48 at posttest and follow-up, respectively. ConclusionsMental health apps have the potential to be effective and may significantly improve treatment accessibility. However, the majority of apps that are currently available lack scientific evidence about their efficacy. The public needs to be educated on how to identify the few evidence-based mental health apps available in the public domain to date. Further rigorous research is required to develop and test evidence-based programs. Given the small number of studies and participants included in this review, the high risk of bias, and unknown efficacy of long-term follow-up, current findings should be interpreted with caution, pending replication. Two of the 5 evidence-based mental health apps are currently commercially available in app stores.

BackgroundTurkish migrants living in the Netherlands have a high prevalence of depressive disorders, but experience considerable obstacles to accessing professional help. Providing easily accessible Internet treatments may help to overcome these barriers. ObjectiveThe aim of this study was to evaluate the effectiveness of a culturally sensitive, guided, self-help, problem-solving intervention through the Internet for reducing depressive symptoms in Turkish migrants. MethodsA two-armed randomized controlled trial was conducted. The primary outcome measure was the severity of depressive symptoms; secondary outcome measures were somatic symptoms, anxiety, quality of life, and satisfaction with the treatment. Participants were assessed online at baseline, posttest (6 weeks after baseline), and 4 months after baseline. Posttest results were analyzed on the intention-to-treat sample. Missing values were estimated by means of multiple imputation. Differences in clinical outcome between groups were analyzed with a t test. Cohen’s d was used to determine the between-groups effect size at posttreatment and follow-up. ResultsTurkish adults (N=96) with depressive symptoms were randomized to the experimental group (n=49) or to a waitlist control group (n=47). High attrition rates were found among the 96 participants of which 42% (40/96) did not complete the posttest (6 weeks) and 62% (59/96) participants did not complete the follow-up assessment at 4 months. No significant difference between the experimental group and the control group was found for depression at posttest. Recovery occurred significantly more often in the experimental group (33%, 16/49) than in the control group (9%, 4/47) at posttest (P=.02). Because of the high attrition rate, a completers-only analysis was conducted at follow-up. The experimental group showed significant improvement in depression compared to the control group both at posttest (P=.01) and follow-up (P=.01). ConclusionsThe results of this study did not show a significant effect on the reduction of depressive symptoms. However, the effect size at posttest was high, which might be an indicator of the possible effectiveness of the intervention when assessed in a larger sample and robust trial. Future research should replicate our study with adequately powered samples. Trial RegistrationDutch Trial Register: NTR2303. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2303 (Archived by WebCite at http://www.webcitation.org/6IOxNgoDu).

BackgroundThere is now substantial evidence that Web-based interventions can be effective at changing behavior and successfully treating psychological disorders. However, interest in the impact of usage on intervention outcomes has only been developed recently. To date, persistence with or completion of the intervention has been the most commonly reported metric of use, but this does not adequately describe user behavior online. Analysis of alternative measures of usage and their relationship to outcome may help to understand how much of the intervention users may need to obtain a clinically significant benefit from the program. ObjectiveThe objective of this study was to determine which usage metrics, if any, are associated with outcome in an online depression treatment trial. MethodsCardiovascular Risk E-couch Depression Outcome (CREDO) is a randomized controlled trial evaluating an unguided Web-based program (E-couch) based on cognitive behavioral therapy and interpersonal therapy for people with depression and cardiovascular disease. In all, 280 participants in the active arm of the trial commenced the program, delivered in 12 modules containing pages of text and activities. Usage data (eg, number of log-ins, modules completed, time spent online, and activities completed) were captured automatically by the program interface. We estimated the association of these and composite metrics with the outcome of a clinically significant improvement in depression score on the Patient Health Questionnaire (PHQ-9) of ≥5 points. ResultsIn all, 214/280 (76.4%) participants provided outcome data at the end of the 12-week period and were included in the analysis. Of these, 94 (43.9%) participants obtained clinically significant improvement. Participants logged into the program an average of 18.7 times (SD 8.3) with most (62.1%, 133/214) completing all 12 modules. Average time spent online per log-in was 17.3 minutes (SD 10.5). Participants completed an average of 9 of 18 activities available within the program. In a multivariate regression model, only the number of activities completed per log-in was associated with a clinically significant outcome (OR 2.82, 95% CI 1.05-7.59). The final model predicted 7.4% of variance in outcome. Curve estimates indicated that significant logarithmic (P=.009) and linear (P=.002) relationships existed between activities completed per log-in and clinically significant change. ConclusionsOnly one objective measure of usage was independently associated with better outcome of a Web-based intervention of known effectiveness. The 4 usage metrics retained in the final step of the regression accounted for little outcome variance. Medium level users appeared to have little additional benefit compared to low users indicating that assumptions of a linear relationship between use and outcome may be too simplistic and further models and variables need to be explored to adequately understand the relationship. Trial RegistrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000085077; http://www.anzctr.org.au/ACTRN12610000085077.aspx (Archived by WebCite at http://www.webcitation.org/6K9FQtKBn).

BackgroundFace-to-face cognitive behavioral therapy (CBT) and interpersonal psychotherapy (IPT) are both effective treatments for depressive disorders, but access is limited. Online CBT interventions have demonstrated efficacy in decreasing depressive symptoms and can facilitate the dissemination of therapies among the public. However, the efficacy of Internet-delivered IPT is as yet unknown. ObjectiveThis study examines whether IPT is effective, noninferior to, and as feasible as CBT when delivered online to spontaneous visitors of an online therapy website. MethodsAn automated, 3-arm, fully self-guided, online noninferiority trial compared 2 new treatments (IPT: n=620; CBT: n=610) to an active control treatment (MoodGYM: n=613) over a 4-week period in the general population. Outcomes were assessed using online self-report questionnaires, the Center for Epidemiological Studies Depression scale (CES-D) and the Client Satisfaction Questionnaire (CSQ-8) completed immediately following treatment (posttest) and at 6-month follow-up. ResultsCompleters analyses showed a significant reduction in depressive symptoms at posttest and follow-up for both CBT and IPT, and were noninferior to MoodGYM. Within-group effect sizes were medium to large for all groups. There were no differences in clinical significant change between the programs. Reliable change was shown at posttest and follow-up for all programs, with consistently higher rates for CBT. Participants allocated to IPT showed significantly lower treatment satisfaction compared to CBT and MoodGYM. There was a dropout rate of 1294/1843 (70%) at posttest, highest for MoodGYM. Intention-to-treat analyses confirmed these findings. ConclusionsDespite a high dropout rate and lower satisfaction scores, this study suggests that Internet-delivered self-guided IPT is effective in reducing depressive symptoms, and may be noninferior to MoodGYM. The completion rates of IPT and CBT were higher than MoodGYM, indicating some progress in refining Internet-based self-help. Internet-delivered treatment options available for people suffering from depression now include IPT. Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 69603913; http://www.controlled-trials.com/ISRCTN69603913 (Archived by WebCite at http://www.webcitation.org/6FjMhmE1o)

BackgroundInterventions to promote mental well-being can bring benefits to the individual and to society. The Internet can facilitate the large-scale and low-cost delivery of individually targeted health promoting interventions. ObjectiveTo evaluate the effectiveness of a self-directed Internet-delivered cognitive-behavioral skills training tool in improving mental well-being in a population sample. MethodsThis was a randomized trial with a waiting-list control. Using advertisements on a national health portal and through its mailing list, we recruited 3070 participants aged 18 or over, resident in England, and willing to give their email address and access a fully automated Web-based intervention. The intervention (MoodGYM) consisted of 5 interactive modules that teach cognitive-behavioral principles. Participants in the intervention arm received weekly email reminders to access the intervention. The control group received access to the intervention after the trial was completed and received no specific intervention or email reminders. Outcomes were assessed by using self-completion questionnaires. The primary outcome was mental well-being measured with the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Secondary outcomes were Center for Epidemiologic Studies Depression scale (CES-D) depression scores, Generalized Anxiety Disorder 7-item scale (GAD-7) anxiety scores, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life scores, physical activity, and health service use. All outcomes were measured at baseline, and at 6- and 12-week follow-ups. ResultsA total of 1529 (49.80%) participants completed final follow-up at 12 weeks. Retention was 73.11% (1123/1536) in the control arm and 26.47% (406/1534) in the intervention arm. No relationship between baseline measures and withdrawal could be established. The analysis of WEMWBS mental well-being scores using a linear mixed model for repeated measures showed no difference between intervention and control group at baseline (difference –0.124 points, 95% CI –0.814 to 0.566), and significant improvements for the intervention group at 6 weeks (2.542 points, 95% CI 1.693-3.390) and at 12 weeks (2.876 points, 95% CI 1.933-3.819). The model showed a highly significant (P

BackgroundAn earlier report indicated that callers to a telephone counseling service benefited from the addition of an evidence-based Web intervention for depression. It is not known whether the Web intervention would also lower alcohol use and stigma, or improve quality of life and knowledge of depression and its treatments. ObjectiveTo report the secondary outcomes of a trial of a Web-based cognitive behavior therapy (CBT) intervention for depression, including hazardous alcohol use, quality of life, stigma, depression literacy, and CBT literacy. MethodsWe recruited a sample of 155 callers to Lifeline, a national telephone counseling service in Australia, who met the criteria for moderate to high psychological distress. Participants were randomly assigned to 1 of 4 conditions: (1) Web CBT plus weekly telephone tracking, (2) Web CBT only, (3) weekly telephone tracking only, and (4) neither Web CBT nor telephone tracking. Participants were assessed at preintervention, postintervention, and 6 and 12 months postintervention. ResultsAt postintervention, participants who completed the Web intervention either with or without telephone support had lower levels of hazardous alcohol use (without tracking: P = .008, effect size = 0.23; with tracking: P = .003, effect size = 0.26), improved quality of life (without tracking: P = .001, effect size = 0.81; with tracking: P = .009, effect size = 0.63), and improved CBT literacy (without tracking: P = .01, effect size = 0.71; with tracking: P < .001, effect size = 0.80) compared with those who did not receive the Web intervention or telephone support. Results for quality of life and CBT literacy were maintained at 6- and 12-month’s follow-up, but differences in hazardous alcohol use were not significantly different between conditions at 6 and 12 months. Although omnibus tests for depression literacy and stigma were nonsignificant, contrasts revealed that those in the Web-only condition showed significantly lower levels of stigma than participants in the control condition at postintervention. This was true for participants in the Web-only and Web plus tracking conditions at 6 months. Similarly, those in the Web-only and Web plus tracking conditions had significantly higher depression literacy at postintervention, and this was maintained in the Web-only condition at 6-months’ follow-up. No significant differences were found in depression literacy and stigma between conditions at 12 months. ConclusionsEvidence-based Web interventions for depression can be effective not only in reducing depression symptoms but also in improving other health outcomes, including quality of life, hazardous alcohol use, and knowledge about effective strategies for depression self-management. Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 93903959; http://www.controlled-trials.com/ISRCTN93903959/ (Archived by WebCite at http://www.webcitation.org/65y61nSsH)

BackgroundMental disorders are more common in young adults than at any other life stage. Despite this, young people have low rates of seeking professional help for mental health problems. Young elite athletes have less positive attitudes toward seeking help than nonathletes and thus may be particularly unlikely to seek help. Interventions aimed at increasing help-seeking in young elite athletes are warranted. ObjectiveTo test the feasibility and efficacy of three Internet-based interventions designed to increase mental health help-seeking attitudes, intentions, and behavior in young elite athletes compared with a control condition. MethodsWe conducted a randomized controlled trial (RCT) of three brief fully automated Internet-based mental health help-seeking interventions with 59 young elite athletes recruited online in a closed trial in Australia. The interventions consisted of a mental health literacy and destigmatization condition, a feedback condition providing symptom levels, and a minimal content condition comprising a list of help-seeking resources, compared with a control condition (no intervention). We measured help-seeking attitudes, intentions and behavior using self-assessed surveys. Participation was open to elite athletes regardless of their mental health status or risk of mental illness. ResultsOf 120 athletes initially agreeing to participate, 59 (49%) submitted a preintervention or postintervention survey, or both, and were included in the present study. Adherence was satisfactory, with 48 (81%) participants visiting both weeks of assigned intervention material. None of the interventions yielded a significant increase in help-seeking attitudes, intentions, or behavior relative to control. However, at postintervention, there was a trend toward a greater increase in help-seeking behavior from formal sources for the mental health literacy/destigmatization condition compared with control (P = .06). This intervention was also associated with increased depression literacy (P = .003, P = .005) and anxiety literacy (P = .002, P = .001) relative to control at postintervention and 3-month follow-up, respectively, and a reduction in depression stigma relative to control at postintervention (P = .01, P = .12) and anxiety stigma at 3-month follow-up (P = .18, P = .02). The feedback and help-seeking list interventions did not improve depression or anxiety literacy or decrease stigmatizing attitudes to these conditions. However, the study findings should be treated with caution. Due to recruitment challenges, the achieved sample size fell significantly short of the target size and the study was underpowered. Accordingly, the results should be considered as providing preliminary pilot data only. ConclusionsThis is the first RCT of an Internet-based mental health help-seeking intervention for young elite athletes. The results suggest that brief mental health literacy and destigmatization improves knowledge and may decrease stigma but does not increase help-seeking. However, since the trial was underpowered, a larger trial is warranted. Trial Registration2009/373 (www.clinicaltrials.gov ID: NCT00940732), cited at http://www.webcitation.org/5ymsRLy9r.

BackgroundAs the popularity of e-therapies grows, so too has the body of literature supporting their effectiveness. However, these interventions are often plagued by high attrition rates and varying levels of user adherence. Understanding the role of adherence may be crucial to understanding how program usage influences the effectiveness of e-therapy interventions. ObjectiveThe aim of this study was to systematically review the e-therapy literature to (1) describe the methods used to assess adherence and (2) evaluate the association of adherence with outcome of these interventions. MethodsA systematic review of e-therapy interventions was conducted across disease states and behavioral targets. Data were collected on adherence measures, outcomes, and analyses exploring the relationship between adherence measures and outcomes. ResultsOf 69 studies that reported an adherence measure, only 33 (48%) examined the relationship between adherence and outcomes. The number of logins was the most commonly reported measure of adherence, followed by the number of modules completed. The heterogeneity of adherence and outcome measures limited analysis. However, logins appeared to be the measure of adherence most consistently related to outcomes in physical health interventions, while module completion was found to be most related to outcomes in psychological health interventions. ConclusionsThere is large variation in the reporting of adherence and the association of adherence with outcomes. A lack of agreement about how best to measure adherence is likely to contribute to the variation in findings. Physical and psychological outcomes seem influenced by different types of adherence. A composite measure encompassing time online, activity completion, and active engagements with the intervention may be the best measure of adherence. Further research is required to establish a consensus for measuring adherence and to understand the role of adherence in influencing outcomes.

This theme issue on e-mental health presents 16 articles from leading researchers working on systems and theories related to supporting and improving mental health conditions and mental health care using information and communication technologies. In this editorial, we present the background of this theme issue, and highlight the content of this issue.

Background There is a need to identify interventions that increase help seeking for depression among young adults. Objective The aim was to evaluate a brief depression information intervention employing health e-cards (personalized emails containing links to health information presented on a Web page). Methods A randomized controlled trial was carried out with 348 19- to 24-year-olds drawn from the community. Participants were randomized to receive one of three conditions, all of which delivered a short series of health e-cards. Two active conditions involved the delivery of depression information designed to increase help-seeking behavior and intentions and to improve beliefs and knowledge associated with help seeking. A control arm delivered information about general health issues unrelated to depression. The primary outcome was help-seeking behavior. Secondary outcomes were help-seeking intentions; beliefs about the efficacy of depression treatments and help sources; ability to recognize depression; knowledge of the help-seeking process; and depressive symptoms. The study’s primary focus was outcomes relating to formal help seeking (consultation with a general practitioner or mental health professional) but also targeted behaviors, intentions, and beliefs relating to informal help seeking. Results Relative to the control condition, depression health e-cards were not associated with an increase in formal help-seeking behavior, nor were they associated with improved beliefs about depression treatments; ability to recognize depression; knowledge of the help-seeking process; or depressive symptoms. Depression e-cards were associated with improved beliefs about the overall efficacy of formal help sources (z = 2.4, P = .02). At post-intervention, participants in all conditions, relative to pre-intervention, were more likely to have higher intentions of seeking help for depression from a formal help source (t641 = 5.8, P < .001) and were more likely to rate interpersonal psychotherapy as being helpful (z = 2.0, P = .047). Depression e-cards were not associated with any significant changes in informal help-seeking behavior, intentions, or beliefs. Conclusions The study found no evidence that providing depression information in the form of brief e-cards encourages help seeking for depression among young adults. Involvement in the study may have been associated with increased help-seeking intentions among participants in all conditions, suggesting that mechanisms other than depression information may increase help seeking. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN98406912; http://www.controlled-trials.com/ISRCTN98406912/ISRCTN98406912 (Archived by WebCite at http://www.webcitation.org/5k221KiMi)

Background Open access websites which deliver cognitive and behavioral interventions for anxiety and depression are characterised by poor adherence. We need to understand more about adherence in order to maximize the impact of Internet-based interventions on the disease burden associated with common mental disorders. Objective The aims of this paper are to review briefly the adherence literature with respect to Internet interventions and to investigate the rates of dropout and compliance in randomized controlled trials of anxiety and depression Web studies. Methods A systematic review of randomized controlled trials using Internet interventions for anxiety and depression was conducted, and data was collected on dropout and adherence, predictors of adherence, and reasons for dropout. Results Relative to reported rates of dropout from open access sites, the present study found that the rates of attrition in randomized controlled trials were lower, ranging from approximately 1 - 50%. Predictors of adherence included disease severity, treatment length, and chronicity. Very few studies formally examined reasons for dropout, and most studies failed to use appropriate statistical techniques to analyze missing data. Conclusions Dropout rates from randomized controlled trials of Web interventions are low relative to dropout from open access websites. The development of theoretical models of adherence is as important in the area of Internet intervention research as it is in the behavioral health literature. Disease-based factors in anxiety and depression need further investigation.

Background There have been no previous studies of the variables that predict adherence to online depression and anxiety intervention programs among adolescents. However, research of traditionally delivered intervention programs for a variety of health conditions in adolescence suggests that health knowledge, type and level of symptomatology, race, socioeconomic status, treatment setting, and support may predict adherence. ObjectiveThe aim was to compare adherence rates and identify the predictors of adherence to a cognitive behavior therapy website in two adolescent samples that were offered the program in different settings and under different conditions of support. MethodsThe first adolescent sample consisted of 1000 school students who completed the MoodGYM program in a classroom setting over five weeks as part of a randomized controlled trial. The second sample consisted of 7207 adolescents who accessed the MoodGYM program spontaneously and directly through the open access URL. All users completed a brief survey before the start of the program that measured background characteristics, depression history, symptoms of depression and anxiety, and dysfunctional thinking. Results Adolescents in the school-based sample completed significantly more online exercises (mean = 9.38, SD = 6.84) than adolescents in the open access community sample (mean = 3.10, SD = 3.85; t1088.62 = −28.39, P < .001). A multiple linear regression revealed that school-based setting (P < .001) and female gender (P < .001) were predictive of greater adherence, as were living in a rural area (P < .001) and lower pre-test anxiety (P = .04) scores for the school-based sample and higher pre-test depression scores (P = .01) for the community sample. A history of depression (P = .33) and pre-test warpy thoughts scores (P = .35) were not predictive of adherence in the school-based or community sample. Conclusion Adherence is greater in monitored settings, and the predictors of adherence differ between settings. Understanding these differences may improve program effectiveness and efficiency.

The feasibility of addressing the mental health needs of young people at school is influenced by how staff perceive their role, and the role of schools, in mental health care. Using qualitative methodology, this study investigated the roles of Australian school teachers and counselors. The aims were two-fold: (i) to explore how teachers and counselors perceive the role of the school in student mental health; and (ii) to explore their views about what is being practically done in schools to provide this support. Ninety-one secondary school teachers and 83 counselors (M[subscript age] = 39.45) across New South Wales responded to open-ended questions between November 2017 and July 2018. Key themes included support, being on the frontline, collaboration, and education, although there were some discrepancies between staff. Further, counselors endorsed evidence-based programs in schools that directly targeted student mental health. Results indicated that clear professional roles and a coordinated effort are needed to appropriately address student mental health.

The coronavirus disease 2019 (COVID-19) pandemic is having a profound effect on all aspects of society, including mental health and physical health. We explore the psychological, social, and neuroscientific effects of COVID-19 and set out the immediate priorities and longer-term strategies for mental health science research. These priorities were informed by surveys of the public and an expert panel convened by the UK Academy of Medical Sciences and the mental health research charity, MQ: Transforming Mental Health, in the first weeks of the pandemic in the UK in March, 2020. We urge UK research funding agencies to work with researchers, people with lived experience, and others to establish a high level coordination group to ensure that these research priorities are addressed, and to allow new ones to be identified over time. The need to maintain high-quality research standards is imperative. International collaboration and a global perspective will be beneficial. An immediate priority is collecting high-quality data on the mental health effects of the COVID-19 pandemic across the whole population and vulnerable groups, and on brain function, cognition, and mental health of patients with COVID-19. There is an urgent need for research to address how mental health consequences for vulnerable groups can be mitigated under pandemic conditions, and on the impact of repeated media consumption and health messaging around COVID-19. Discovery, evaluation, and refinement of mechanistically driven interventions to address the psychological, social, and neuroscientific aspects of the pandemic are required. Rising to this challenge will require integration across disciplines and sectors, and should be done together with people with lived experience. New funding will be required to meet these priorities, and it can be efficiently leveraged by the UK's world-leading infrastructure. This Position Paper provides a strategy that may be both adapted for, and integrated with, research efforts in other countries.