Testing the Effectiveness of a Mobile Smartphone App Designed to Improve the Mental Health of Junior Physicians: Protocol for a Randomized Controlled Trial.

BACKGROUND: Shift (Black Dog Institute) is the first mobile health smartphone app created to support the mental health of junior physicians. Junior physicians experience demanding work conditions, leading to high levels of psychological distress and burnout. However, they are often concerned about the potential career impacts of seeking mental health support. The confidentiality and ease of access of digital interventions may be particularly suited to address these concerns. The Shift app provides therapeutic and psychoeducational content and strategies contextualized for the specific needs of physicians in training. App content includes information on mental health, help seeking, mindfulness, and common workplace-related concerns of junior physicians. OBJECTIVE: This study aims to test, at scale, the effectiveness of Shift among junior physicians working in Australia using a randomized controlled trial design. The primary aim is to examine whether junior physicians using Shift experience a reduction in depressive symptoms compared with a waitlist control group. The secondary aim is to examine whether the app intervention group experiences improvements in anxiety, work and social functioning, help seeking, quality of life, and burnout compared with the control group. METHODS: A total of 778 junior physicians were recruited over the internet through government and nongovernment medical organizations across Australia, as well as through paid social media advertisements. They were randomly allocated to one of 2 groups: (1) the intervention group, who were asked to use the Shift app for a period of 30 days, or (2) the waitlist control group, who were placed on a waitlist and were asked to use the app after 3 months. Participants completed psychometric measures for self-assessing mental health and wellbeing outcomes, with assessments occurring at baseline, 1 month after completing the baseline period, and 3 months after completing the baseline period. Participants in the waitlist control group were asked to complete an additional web-based questionnaire 1 month after receiving access to the app or 4 months after completing the baseline survey. Participants took part in the study on the internet; the study was completely automated. RESULTS: The study was funded from November 2022 to December 2024 by the New South Wales Ministry of Health. Data collection for the study occurred between January and August 2024, with 780 participants enrolling in the study during this time. Data analysis is underway; the effectiveness of the intervention will be estimated on an intention-to-treat basis using a mixed-model, repeated measures analysis. Results are expected to be submitted for publication in 2025. CONCLUSIONS: To the best of our knowledge, this is the first randomized controlled trial to examine the effectiveness of a mobile health smartphone app specifically designed to support the mental health of junior physicians. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12623000664640; https://tinyurl.com/7xt24dhk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58288.

A mentally healthy framework to guide employers and policy makers.

Mental health problems among the working population represent a growing concern with huge impacts on individuals, organizations, compensation authorities, and social welfare systems. The workplace presents both psychosocial risks and unique opportunities for intervention. Although there has been rapid expansion of workplace mental health interventions over recent decades, clear direction around appropriate, evidence-based action remains limited. While numerous workplace mental health models have been proposed to guide intervention, general models often fail to adequately consider both the evidence base and where best-practice principles alone inform action. Further, recommendations need to be updated as new discoveries occur. We seek to update the Framework for Mentally Healthy Workplaces based on new evidence of intervention effectiveness while also incorporating evidence-based principles. The updated model also integrates concepts from existing alternate models to present a comprehensive overview of strategies designed to enhance wellbeing, minimize harm, and facilitate recovery. Examples of available evidence and obstacles to implementation are discussed. The Framework is designed to support employers and managers in determining which strategies to apply and to guide future avenues of research.

Systematic Search and Scoping Review of Physicians' Intolerance of Uncertainty and Medical Decision-Making Uncertainties During the COVID-19 Pandemic: A Summary of the Literature and Directions for Future Research.

Pandemic-related uncertainties and intolerance of uncertainty (IU) could negatively affect physicians' well-being and functioning, being associated with experiences of distress and problematic decision-making processes. To summarize the available quantitative and qualitative evidence of physicians' IU and decisional uncertainty during COVID-19 and problems associated with it, a systematic search was conducted to identify all relevant articles describing physician uncertainty with regard to medical decision making and well-being in COVID-19 pandemic conditions. Medical, psychological, and preprint databases were searched. Ten articles met all eligibility criteria, with eight describing quantitative and two describing qualitative research outcomes, assessed primarily in European regions and via online surveys. Associations between IU and symptoms of poor mental health and mental health risk factors were widespread, but inconsistencies emerged. Qualitative studies emphasized decisional uncertainty as a stressor for physicians, and quantitative studies suggest it may have fostered more unproven treatment choices. While the prevalence and impact of physician uncertainty under COVID-19 conditions requires further investigation, sighting available literature indicates that IU coincided with experiences of poor mental health and, at least towards the beginning of the pandemic, with willingness to endorse unproven treatments. Efforts to reduce uncertainty-related problems for physicians seem warranted, for example, through normalizing experiences of uncertainty or reducing avoidable uncertainty through maintaining open and timely communication channels.

Mental health and unemployment: A systematic review and meta-analysis of interventions to improve depression and anxiety outcomes.

BACKGROUND: Unemployment is associated with substantially greater depression and anxiety, constituting a considerable public health concern. The current review provides the most comprehensive synthesis to date, and first meta-analysis, of controlled intervention trials aimed at improving depression and anxiety outcomes during unemployment. METHODS: Searches were conducted within PsycInfo, Cochrane Central, PubMed and Embase from their inception to September 2022. Included studies conducted controlled trials of interventions focused on improving mental health within unemployed samples, and reported on validated measures of depression, anxiety, or distress (mixed depression and anxiety). Narrative syntheses and random effects meta-analyses were conducted among prevention- and treatment-level interventions for each outcome. RESULTS: A total of 39 articles reporting on 33 studies were included for review (sample sizes ranging from 21 to 1801). Both prevention and treatment interventions tended to be effective overall, with treatment interventions producing larger effect sizes than prevention interventions. The clearest evidence for particular intervention approaches emerged for prevention-level Cognitive Therapy/CBT, followed by prevention-level work-related interventions, although neither produced entirely consistent effects. LIMITATIONS: Risk of bias was generally high across studies. Low numbers of studies within subgroups precluded any comparisons between long-term and short-term unemployment, limited comparisons among treatment studies, and reduced the power of meta-analyses. CONCLUSIONS: Both prevention- and treatment-level mental health-focused interventions have merit for reducing symptoms of anxiety and depression among those experiencing unemployment. Cognitive Therapy/CBT and work-related interventions hold the most robust evidence base, which can inform both prevention and treatment strategies implemented by clinicians, employment services providers, and governments.

On-campus mental health services for Australian university students: A retrospective analysis of service utilisation.

OBJECTIVE: To investigate on-campus mental health service utilisation by Australian university students. METHOD: Retrospective analysis of clinical data from two on-campus health services (general practice and psychology and counselling service). Descriptive statistics include total consults, demographic factors, diagnoses, presenting concerns and rates of suicidal ideation. RESULTS: Mental health conditions account for the largest proportion of ongoing illness in on-campus health service users, representing 46% of all ongoing health conditions. Depression and anxiety were the most common diagnoses, and stress, anxiety and low mood were the most common presenting concerns. Females utilise mental health services more frequently than males, accounting for 65.3% and 60.1% of patients for the respective services. International students present for specific mental health consults less frequently than domestic students. Rates of suicidal ideation at presentation were high (37%). CONCLUSIONS: This retrospective analysis provides important information regarding the proportion and distribution of mental health conditions and service utilisation amongst Australian university students. There is clear scope for increased access to specialist care, renewed efforts to decrease stigma and increase rates of presentation (particularly amongst international students and males), greater support for general practitioners and more rigorous routine data collection and reporting, both within and across universities nationally.

Correction: Preliminary Investigation of Shift, a Novel Smartphone App to Support Junior Doctors' Mental Health and Well-being: Examination of Symptom Progression, Usability, and Acceptability After 1 Month of Use.

[This corrects the article DOI: 10.2196/38497.].

An exploratory investigation of the reliability and validity of the Independent-Interdependent Problem-Solving Style Scale.

The Independent-Interdependent Problem-Solving Scale is based on Cross et al.'s conceptualisation of relational-interdependent self-construal. The IIPSS provides a relatively context-free measure of people's tendencies to solve problems independently or with the help of others. Because previous investigations have not provided extensive evidence for the reliability and validity of the IIPSS, the current research aimed to test the psychometric properties of this novel measure. Investigations of four student samples (combined N = 1157) and one sample comprised of academic researchers (N = 198) generally supported the reliability and validity of the IIPSS. Exploratory factor analysis of IIPSS items yielded a single factor structure. However, confirmatory factor analyses did not demonstrate good model fit for the one factor solution and instead yielded good model fit for two underlying factors. The IIPSS showed adequate test-retest reliability and predicted positive associations with social personality traits. It also showed no significant associations with measures of demand characteristics and social desirability. Future research needs to be undertaken to further assess the factor structure and address shortcomings of the present research such as utilising objective data in addition to self-reports to assess the scale's validity.

The Influence of Stigma Perceptions on Employees' Claims Experiences for Psychological Injuries: Re-Examination of a Cross-Sectional Survey among Australian Police and Emergency Service Personnel.

While a large body of research assessed the contribution of mental health stigma on disclosure, treatment seeking, and recovery, limited research exists seeking to identify the relative contribution of stigma beliefs on workers' compensation claims for psychological injury. Survey data of ambulance, fire and rescue, police, and state emergency service personnel (N = 1855, aged 45-54 years, 66.4% male) was re-examined to assesses the unique and combined associations of self-, personal, and workplace stigma with workers' compensation claims experiences and recovery. Participants responded to self-report stigma items (predictor variables), perceived stress, fairness, and support perceptions of going through the claims process and its impact on recovery (outcome variables). Multiple regression analyses revealed that the combined stigma dimensions predicted about one fifth of the variance of claims and recovery perceptions. Organisational commitment beliefs and the self-stigma dimension of experiences with others were the two most important, albeit weak, unique predictors across outcomes. Given the small but consistent influences of organisational commitment beliefs and the self-stigma dimension of experiences with others, it seems warranted to apply workplace interventions that are looking to establish positive workplace contact and a supportive organisational culture to alleviate negative effects attributable to mental health stigma.

Preliminary Investigation of Shift, a Novel Smartphone App to Support Junior Doctors' Mental Health and Well-being: Examination of Symptom Progression, Usability, and Acceptability After 1 Month of Use.

BACKGROUND: Shift is a novel smartphone app for providing a digital-first mental health resource to junior doctors. It contains psychoeducational material, cognitive behavioral modules, guided mediations, information on common work stressors, and a section on help-seeking options for psychological problems through workplace and private avenues. OBJECTIVE: This study aimed to conduct a preliminary investigation of the use and potential effectiveness of Shift on depressive and anxiety symptoms (primary outcomes) and work and social functioning, COVID-19 safety concerns, and help seeking (secondary outcomes). This study also sought feedback on whether Shift was seen as an acceptable tool. METHODS: Junior doctors in New South Wales, Australia, were approached through promotional activities from the Ministry of Health, specialist medical colleges, and social media advertisements between June and August 2020. Consenting participants provided web-based baseline data, used the Shift app for 30 days, and were asked to complete a poststudy web-based questionnaire. Outcomes were analyzed under the intention-to-treat principle. RESULTS: A total of 222 (n=156 female, 70.3%; mean age 29.2, SD 4.61 years) junior doctors provided full baseline data. Of these, 89.2% (198/222) downloaded the app, logged into the app approximately 6 times (mean 5.68, SD 7.51), completed 4 in-app activities (mean 3.77, SD 4.36), and spent a total of 1 hour on in-app activities (mean 52:23, SD 6:00:18) over 30 days. Postintervention and app use data were provided by 24.3% (54/222) of participants. Depressive and anxiety symptoms significantly decreased between the pre- and postassessment points as expected; however, physicians' COVID-19 safety concerns significantly increased. Work and social functioning, COVID-19 concerns for family and friends, and help seeking did not change significantly. There was no significant relationship between symptom changes and app use (number of log-ins, days between first and last log-in, and total activity time). Most poststudy completers (31/54, 57%) rated Shift highly or very highly. CONCLUSIONS: Despite high levels of nonresponse to the poststudy assessment and increases in COVID-19 safety concerns, junior doctors who used the app reported some improvements in depression and anxiety, which warrant further exploration in a robust manner.

A systematic literature review and narrative synthesis of effective interventions for family and caregivers of people who use methamphetamine.

Background: Methamphetamine is a highly addictive central nervous stimulant associated with numerous adverse health, psychological, and social impacts. Family and friends of people who use methamphetamine often take on a crucial caregiving role in supporting their loved one. Consequently, they can experience a range of psychosocial challenges themselves. This review aimed to identify and assess the effectiveness of interventions designed to support caregivers of people who use methamphetamine. Methods: A systematic search of relevant literature published in the English language was conducted. Of 2257 records identified, only 2 evaluation studies examined interventions specifically designed for caregivers of people who use methamphetamine. Additionally, four qualitative accounts described experiences of caring for people who use methamphetamine. These accounts were summarized narratively to provide a more complete picture of family and caregiver experiences and coping strategies. Results: Effective treatment components included tending to caregiver concerns and providing training to enhance informational support and problem-solving skills. Qualitative accounts uncovered a range of challenges experienced by caregivers, such as emotional distress, concern for the person using methamphetamine, disrupted family structures, and financial difficulties. Coping strategies included attempts at managing and supporting the person using methamphetamine while protecting the overall cohesion and wellbeing of the family unit. Conclusions: This review highlighted a lack of evidence-based interventions for caregivers of people who use methamphetamine. More research is needed to clarify concerns that may be particularly relevant for those in a caregiving role.

Junior doctors' mental health and coronavirus disease safety concerns.

OBJECTIVE: This article aims to assess whether caring for COVID-19 patients impacted junior doctors' COVID-19-related anxieties, general anxiety and depression, and the relative impact of depression, general anxiety and specific COVID-19 anxiety on work and social functioning during the COVID-19 pandemic in 2020. METHODS: Recruitment occurred between June and August 2020 in New South Wales, Australia. Demographic information, symptoms of depression (PHQ-9), generalised anxiety (GAD-7), and COVID-19-related anxieties around infections, help-seeking behaviours, and work and social functioning (WSAS) were collected. RESULTS: About one third (n=73, 33%) had cared for a patient with overt or covert COVID-19 in the previous month. However, the extent of COVID-19-related anxiety symptoms was largely unrelated to caring for COVID-19 patients. Instead, the presence of other COVID-19 concerns and gender predicted variations in COVID-19 concerns for one's own safety and the safety of loved ones. CONCLUSION: COVID-19 anxiety symptoms were largely unrelated to caring for COVID-19 patients, while COVID-19-related anxiety around the safety of family and friends added to impaired functioning in addition to the established impact of depression and general anxiety. IMPLICATIONS FOR PUBLIC HEALTH: Provided the replicability of these findings, this research highlights the importance of addressing pandemic-related anxieties in junior doctor populations.

Development of the Shift Smartphone App to Support the Emotional Well-Being of Junior Physicians: Design of a Prototype and Results of Usability and Acceptability Testing.

BACKGROUND: Junior physicians report higher levels of psychological distress than senior doctors and report several barriers to seeking professional mental health support, including concerns about confidentiality and career progression. Mobile health (mHealth) apps may be utilized to help overcome these barriers to assist the emotional well-being of this population and encourage help-seeking. OBJECTIVE: This study describes the development and pilot trial of the Shift mHealth app to provide an unobtrusive avenue for junior physicians to seek information about, and help for, well-being and mental health concerns, which is sensitive to workplace settings. METHODS: A 4-phase iterative development process was undertaken to create the content and features of Shift involving junior physicians using the principles of user-centered design. These 4 phases were-needs assessment, on the basis of interviews with 12 junior physicians; prototype development with user experience feedback from 2 junior physicians; evaluation, consisting of a pilot trial with 22 junior physicians to assess the usability and acceptability of the initial prototype; and redesign, including user experience workshops with 51 junior physicians. RESULTS: Qualitative results informed the content and design of Shift to ensure that the app was tailored to junior physicians' needs. The Shift app prototype contained cognitive behavioral, mindfulness, value-based actions, and psychoeducational modules, as well as a tracking function that visualized patterns of daily variations in mood and health behaviors. Pilot-testing revealed possible issues with the organization of the app content, which were addressed through a thorough restructuring and redesign of Shift with the help of junior physicians across 3 user experience workshops. CONCLUSIONS: This study demonstrates the importance of ongoing end user involvement in the creation of a specialized mHealth app for a unique working population experiencing profession-specific stressors and barriers to help-seeking. The development and pilot trial of this novel Shift mHealth app are the first steps in addressing the mental health and support-seeking needs of junior physicians, although further research is required to validate its effectiveness and appropriateness on a larger scale.

Factors Predicting Trial Engagement, Treatment Satisfaction, and Health-Related Quality of Life During a Web-Based Treatment and Social Networking Trial for Binge Drinking and Depression in Young Adults: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Mental health and alcohol use problems are among the most common causes of disease burden in young Australians, frequently co-occur (comorbidity), and lead to significant lifetime burden. However, comorbidities remain significantly underdetected and undertreated in health settings. Digital mental health tools designed to identify at-risk individuals, encourage help-seeking, or deliver treatment for comorbidity have the potential to address this service gap. However, despite a strong body of evidence that digital mental health programs provide an effective treatment option for a range of mental health and alcohol use problems in young adults, research shows that uptake rates can be low. Thus, it is important to understand the factors that influence treatment satisfaction and quality-of-life outcomes for young adults who access e-mental health interventions for comorbidity. OBJECTIVE: In this study, we seek to understand the factors that influence treatment satisfaction and quality-of-life outcomes for young adults who access e-mental health interventions for comorbid alcohol and mood disorders. The aim is to determine the importance of personality (ie, Big Five personality traits and intervention attitudes), affective factors (ie, depression, anxiety, and stress levels), and baseline alcohol consumption in predicting intervention trial engagement at sign-up, satisfaction with the online tool, and quality of life at the end of the iTreAD (Internet Treatment for Alcohol and Depression) trial. METHODS: Australian adults (N=411) aged between 18 and 30 years who screened positive for depression and alcohol use problems signed up for the iTreAD project between August 2014 and October 2015. During registration, participants provided information about their personality, current affective state, alcohol use, treatment expectations, and basic demographic information. Subsequent follow-up surveys were used to gauge the ongoing trial engagement. The last follow-up questionnaire, completed at 64 weeks, assessed participants' satisfaction with web-based treatment and quality-of-life outcomes. RESULTS: Multiple linear regression analyses were used to assess the relative influence of predictor variables on trial engagement, treatment satisfaction, and quality-of-life outcomes. The analyses revealed that the overall predictive effects of personality and affective factors were 20% or lower. Neuroticism constituted a unique predictor of engagement with the iTreAD study in that neuroticism facilitated the return of web-based self-assessments during the study. The return of incentivized follow-up assessments predicted treatment satisfaction, and state-based depression predicted variance in quality-of-life reports at study completion. CONCLUSIONS: Our findings suggest that traditional predictors of engagement observed in face-to-face research may not be easily transferable to digital health interventions, particularly those aimed at comorbid mental health concerns and alcohol misuse among young adults. More research is needed to identify what determines engagement in this population to optimally design and execute digital intervention studies with multiple treatment aims. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN): 12614000310662; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365137&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-015-2365-2.

e-Mental Health Program Usage Patterns in Randomized Controlled Trials and in the General Public to Inform External Validity Considerations: Sample Groupings Using Cluster Analyses.

BACKGROUND: Randomized 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. OBJECTIVE: Clustering 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. METHODS: Australian 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. RESULTS: Samples 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 <.001). Two-step cluster analyses revealed 3 user groups in the RCT sample (Nonstarters, 10-Timers, and 30+-Timers) and 2 user groups in the community samples (2-Timers and 20-Timers). Groups seemed comparable in patterns of use but differed in magnitude, with RCT participant usage groups showing more frequent engagement than community usage groups. Only the high-usage group among RCT participants approached myCompass usage recommendations. CONCLUSIONS: Findings suggested that external validity concerns of RCT designs may arise with regards to the predicted magnitude of eMH program use rather than overall usage styles. Following up RCT nonstarters may help provide unique insights into why individuals choose not to engage with an eMH program despite generally being willing to participate in an eMH evaluation study. Overestimating frequency of engagement with eMH tools may have theoretical implications and potentially impact economic considerations for plans to disseminate these tools to the general public.

A Web-Based Mental Health Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The Springboard Trial): 12-Month Outcomes of a Randomized Controlled Trial.

BACKGROUND: People 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. OBJECTIVE: This 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. METHODS: Adults 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. RESULTS: A 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. CONCLUSIONS: The 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 REGISTRATION: Australian New Zealand Clinical Trials Registry Number (ACTRN) 12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true.

The influence of personality on trajectories of distress, health and functioning in mild-to-moderately depressed adults with type 2 diabetes.

Identification of mental health risk is important for optimising diabetes care in type 2 diabetes mellitus (T2DM). Personality is linked to diabetes health and may assist detection of individuals with T2DM most at risk of chronic mental health difficulties. This study examined the moderator effect of personality factors on changes in psychological distress and functioning in adults with T2DM and mild-to-moderate depressive symptoms across a 12-month period. Data were obtained from participants in a randomised controlled trial of adults with T2DM.  Participants completed measures of depression (Patient Health Questionnaire-9), anxiety (General Anxiety Disorder-7), general functioning (Work and Social Adjustment Scale), diabetes distress (Diabetes Distress Scale), and diabetes self-management (Self-Management Profile for Type 2 Diabetes) at baseline, 3-, 6- and 12-months. Glycaemic control (HbA1c) was measured at baseline, 6- and 12-months. Two hundred trial completers agreed to complete a personality inventory (Big Five Inventory). Low neuroticism was linked with reduced depression, anxiety, functional impairment and diabetes distress over the year. High extraversion was associated with decreased anxiety and functional impairment. High conscientiousness was linked to increased healthy eating. No personality trait moderated HbA1c levels. Personality screening may help identify mental health risk and guide medical carer approach in T2DM patients.

Using Cluster Analysis to Explore Engagement and e-Attainment as Emergent Behavior in Electronic Mental Health.

BACKGROUND: In most e-mental health (eMH) research to date, adherence is defined according to a trial protocol. However, adherence to a study protocol may not completely capture a key aspect of why participants engage with eMH tools, namely, to achieve personal mental health goals. As a consequence, trial attrition reported as non-adherence or dropout may reflect e-attainment, the discontinuation of eMH engagement after personal goals have been met. Clarifying engagement patterns, such as e-attainment, and how these align with mental health trajectories, may help optimize eMH design and implementation science. OBJECTIVE: This study aimed to use clustering techniques to identify real-world engagement profiles in a community of eMH users and examine if such engagement profiles are associated with different mental health outcomes. The novelty of this approach was our attempt to identify actual user engagement behaviors, as opposed to employing engagement benchmarks derived from a trial protocol. The potential of this approach is to link naturalistic behaviors to beneficial mental health outcomes, which would be especially informative when designing eMH programs for the general public. METHODS: Between May 2013 and June 2018, Australian adults (N=43,631) signed up to myCompass, a self-guided eMH program designed to help alleviate mild to moderate symptoms of depression, anxiety, and stress. Recorded usage data included number of logins, frequency of mood tracking, number of started and completed learning activities, and number of tracking reminders set. A subset of users (n=168) completed optional self-assessment mental health questionnaires (Patient Health Questionnaire-9 item, PHQ-9; Generalized Anxiety Disorder Questionnaire-7 item, GAD-7) at registration and at 28 and 56 days after sign-up. Another subset of users (n=861) completed the PHQ-9 and GAD-7 at registration and at 28 days. RESULTS: Two-step cluster analyses revealed 3 distinct usage patterns across both subsamples: moderates, trackers, and super users, signifying differences both in the frequency of use as well as differences in preferences for program functionalities. For both subsamples, repeated measures analysis of variances showed significant decreases over time in PHQ-9 and GAD-7 scores. Time-by-cluster interactions, however, did not yield statistical significance in both subsamples, indicating that clusters did not predict symptom reduction over time. Interestingly, users who completed the self-assessment questionnaires twice had slightly but significantly lower depression and anxiety levels at sign-up compared with users who completed the questionnaires a third time at 56 days. CONCLUSIONS: Findings suggested that although users engaged with myCompass in different but measurable ways, those different usage patterns evoked equivalent mental health benefits. Furthermore, the randomized controlled trial paradigm may unintentionally limit the scope of eMH engagement research by mislabeling early mental health goal achievers as dropouts. More detailed and naturalistic approaches to study engagement with eMH technologies may improve program design and, ultimately, program effectiveness.

A Web-Based Cognitive Behavior Therapy Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial.

BACKGROUND: Depressive symptoms are common in people with type 2 diabetes mellitus (T2DM). Effective depression treatments exist; however, access to psychological support is characteristically low. Web-based cognitive behavioral therapy (CBT) is accessible, nonstigmatizing, and may help address substantial personal and public health impact of comorbid T2DM and depression. OBJECTIVE: The aim of this study was to evaluate the Web-based CBT program, myCompass, for improving social and occupational functioning in adults with T2DM and mild-to-moderate depressive symptoms. myCompass is a fully automated, self-guided public health treatment program for common mental health problems. The impact of treatment on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior was also examined. METHODS: Participants with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited online via Google and Facebook advertisements targeting adults with T2DM and via community and general practice settings. Screening, consent, and self-report scales were all self-administered online. Participants were randomized using double-blind computerized block randomization to either myCompass (n=391) for 8 weeks plus a 4-week tailing-off period or an active placebo intervention (n=379). At baseline and postintervention (3 months), participants completed the Work and Social Adjustment Scale, the primary outcome measure. Secondary outcome measures included the Patient Health Questionnaire-9 item, Diabetes Distress Scale, Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. RESULTS: myCompass users logged in an average of 6 times and completed an average of .29 modules. Healthy Lifestyles users logged in an average of 4 times and completed an average of 1.37 modules. At baseline, mean scores on several outcome measures, including the primary outcome of work and social functioning, were near to the normal range, despite an extensive recruitment process. Approximately 61.6% (473/780) of participants completed the postintervention assessment. Intention-to-treat analyses revealed improvement in functioning, depression, anxiety, diabetes distress, and healthy eating over time in both groups. Except for blood glucose monitoring and medication adherence, there were no specific between-group effects. Follow-up analyses suggested the outcomes did not depend on age, morbidity, or treatment engagement. CONCLUSIONS: Improvement in social and occupational functioning and the secondary outcomes was generally no greater for myCompass users than for users of the control program at 3 months postintervention. These findings should be interpreted in light of near-normal mean baseline scores on several variables, the self-selected study sample, and sample attrition. Further attention to factors influencing uptake and engagement with mental health treatments by people with T2DM, and the impact of illness comorbidity on patient conceptualization and experience of mental health symptoms, is essential to reduce the burden of T2DM. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true (Archived by WebCite at http://www.webcitation.org/7850eg8pi).

Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care.

BACKGROUND: E-mental health (eMH) interventions are now widely available and they have the potential to revolutionize the way that health care is delivered. As most health care is currently delivered by primary care, there is enormous potential for eMH interventions to support, or in some cases substitute, services currently delivered face to face in the community setting. However, randomized trials of eMH interventions have tended to recruit participants using online recruitment methods. Consequently, it is difficult to know whether participants who are recruited online differ from those who attend primary care. OBJECTIVE: This paper aimed to document the experience of recruiting to an eMH trial through primary care and compare the characteristics of participants recruited through this and other recruitment methods. METHODS: Recruitment to the SpringboarD randomized controlled trial was initially focused on general practices in 2 states of Australia. Over 15 months, we employed a comprehensive approach to engaging practice staff and supporting them to recruit patients, including face-to-face site visits, regular contact via telephone and trial newsletters, and development of a Web-based patient registration portal. Nevertheless, it became apparent that these efforts would not yield the required sample size, and we therefore supplemented recruitment through national online advertising and promoted the study through existing networks. Baseline characteristics of participants recruited to the trial through general practice, online, or other sources were compared using the analysis of variance and chi square tests. RESULTS: Between November 2015 and October 2017, 780 people enrolled in SpringboarD, of whom 740 provided information on the recruitment source. Of these, only 24 were recruited through general practice, whereas 520 were recruited online and 196 through existing networks. Key barriers to general practice recruitment included perceived mismatch between trial design and diabetes population, prioritization of acute health issues, and disruptions posed by events at the practice and community level. Participants recruited through the 3 different approaches differed in age, gender, employment status, depressive symptoms, and diabetes distress, with online participants being distinguished from those recruited through general practice or other sources. However, most differences reached only a small effect size and are unlikely to be of clinical importance. CONCLUSIONS: Time, labor, and cost-intensive efforts did not translate into successful recruitment through general practice in this instance, with barriers identified at several different levels. Online recruitment yielded more participants, who were broadly similar to those recruited via general practice.

A Web-Based Public Health Intervention to Reduce Functional Impairment and Depressive Symptoms in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial Protocol.

BACKGROUND: Depressive symptoms are common in people with type 2 diabetes and contribute to adverse health consequences that substantially impact social and vocational function. Despite the existence of effective depression treatments, the majority of people with type 2 diabetes do not access these when needed. Web-based alternatives to more traditional psychotherapies offer a potential solution to reducing the personal and economic burdens of type 2 diabetes. OBJECTIVE: This paper outlines the protocol for a randomized controlled trial (RCT) of myCompass, a Web-based public health psychotherapy intervention, in people with type 2 diabetes. Fully automated, interactive, and delivered via the Internet without clinician support, myCompass teaches cognitive behavioral therapy-based skills and supports symptom monitoring to improve daily functioning and reduce mild-to-moderate mental health symptoms. METHODS: A two-arm RCT will be conducted. People with type 2 diabetes and mild-to-moderately severe depressive symptoms will be recruited from the community and general practice settings. Screening and enrollment is via an open-access website. Participants will be randomized to use either myCompass or an active placebo program for 8 weeks, followed by a 4-week tailing-off period. The placebo program is matched to myCompass on mode of delivery, interactivity, and duration. Outcomes will be assessed at baseline and at 3-month, 6-month, and 12-month follow-up. The primary study outcome is work and social functioning. Secondary study outcomes include depressive and anxious symptoms, diabetes-related distress, self-care behaviors, and glycemic control. RESULTS: Nationwide recruitment is currently underway with the aim of recruiting 600 people with type 2 diabetes. Recruitment will continue until October 2017. CONCLUSIONS: This is the first known trial of a Web-based psychotherapy program that is not diabetes specific for improving social and vocational function in people with type 2 diabetes and mild-to-moderately severe depressive symptoms. With the increasing prevalence of type 2 diabetes and depression, a potentially scalable public health intervention could play a very large role in reducing unmet mental health need and ameliorating the personal and societal impact of illness comorbidity. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) Number: ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109 (Archived by WebCite at http://www.webcitation.org/ 6rh3imVMh).