Craig Ferguson

Background: Decentralized (ie, fully remote) clinical trials (DCTs) offer a scalable and ecologically valid approach to evaluating digital mental health interventions (DMHIs). Yet, incorporating objective measures of well-being within DCTs poses novel methodological and feasibility challenges that can limit the rigor and precision of data collection in the field. Objective: We recently conducted the Behavior, Biology, and Well-being (BeWell) Study, a large-scale, 3-arm randomized DCT evaluating the Healthy Minds Program app (Humin)—a self-guided DMHI that includes didactic well-being information and meditation components. The current paper’s objective is to describe the methodological approach to collecting and processing a multimodal battery of psychological (questionnaires and structured clinical interview), biological (blood and stool assays), and behavioral (stimulus-elicited affect [SEA] task, video log, and Mnemonic Similarity Task [MST]) measures, longitudinally across baseline, the 4-week intervention period, and 17-week follow-up. Secondarily, we evaluate its feasibility. Methods: The BeWell Study methodology is described. Descriptive statistics characterized recruitment and retention, as well as data completion and data quality. Binary logistic regressions evaluated whether recruitment sources, demographics, and depression severity predicted measure completion and data quality. Results: From June 1, 2022, through July 15, 2024, 52,052 individuals started the screening questionnaire. Of these, 2.22% (n=1156 participants; mean age 38.69, SD 12.14 years; women=75.50%; non-Hispanic White=68.88%) completed the screener, met eligibility criteria (including elevated depressive symptoms [Patient Health Questionnaire-9 [PHQ-9] score≥5]), completed baseline measures, were enrolled, and were randomized. Participants were recruited from Craigslist (694/1154, 60.14%), a US-based advertisement website, and university email messages (107/1154, 9.27%); participants were enrolled from every US state. Across the study, 84% (971/1156) of participants were retained (completed ≥1 measure at 17-week follow-up). Across time points, ≥81.40% (941/1156) of participants completed questionnaires and ≥75.17% (869/1156) completed biological samples. Of those completing questionnaires, ≥84.14% (796/946) completed SEA and video log tasks and ≥91.75% (868/946) completed the MST. Of completed assessments, high-quality or analyzable data rates across all time points were ≥97.89% (926/946) for questionnaires, ≥90.20% (773/857) for SEA, ≥84.60% (725/857) for video logs, ≥94.20% (1056/1121) for the MST, ≥98.84% (849/859) for dried blood spots, and ≥99.43% () for microbiome samples. Greater depressive symptoms at screening, but not age, predicted completion of baseline measures (odds ratios 0.96‐0.99; P <.001). For enrolled participants, recruitment sources and baseline depressive symptoms were not predictive of data completion or quality. Older age and having a college degree predicted significantly higher rates of data completion across all data types (questionnaire, behavioral, and biological) at week 4 or week 17 follow-ups. Conclusions: This methodological approach offers one model of incorporating objective measures of well-being into DCTs testing DMHIs. Implications and limitations of our approach are discussed.

This paper explores the design, development and evaluation of a digital platform that aims to assist young people who have experienced trauma in understanding and expressing their emotions and fostering social connections. Integrating principles from expressive arts and narrative-based therapies, we collaborate with lived experts to iteratively design a novel, user-centered digital tool for young people to create and share comics that represent their experiences. Specifically, we conduct a series of nine workshops with N=54 trauma-impacted youth and young adults to test and refine our tool, beginning with three workshops using low-fidelity prototypes, followed by six workshops with Cube, a web version of the tool. A qualitative analysis of workshop feedback and empathic relations analysis of artifacts provides valuable insights into the usability and potential impact of the tool, as well as the specific needs of young people who have experienced trauma. Our findings suggest that the integration of expressive and narrative therapy principles into Cube can offer a unique avenue for trauma-impacted young people to process their experiences, more easily communicate their emotions, and connect with supportive communities. We end by presenting implications for the design of social technologies that aim to support the emotional well-being and social integration of youth and young adults who have faced trauma.

Approximately 400,000 youth in the US are living in foster care due to experiences with abuse or neglect at home[17]. For multiple reasons, these youth often don't receive adequate social support from those around them. Despite technology's potential, very little work has explored how these tools can provide more support to foster-involved youth. To begin to fill this gap, we worked with current and former foster-involved youth to develop the first digital tool that aims to increase social support for this population, creating a novel system in which users complete reflective check-ins in an online community setting. We then conducted a pilot study with 15 current and former foster-involved youth, comparing the effect of using the app for two weeks to two weeks of no intervention. We collected qualitative and quantitative data, which demonstrated that this type of interface can provide youth with types of social support that are often not provided by foster care services and other digital interventions. The paper details the motivation behind the app, the trauma-informed design process, and insights gained from this initial evaluation study. Finally, the paper concludes with recommendations for designing digital tools that effectively provide social support to foster-involved youth.

Background: There is increasing interest in the development of scalable digital mental health interventions for perinatal populations to increase accessibility. Mobile behavioral activation (BA) is efficacious for the treatment of perinatal depression; however, the effect of comorbid anxiety and depression (CAD) on symptom trajectories remains underexplored. This is important given that at least 10% of women in the perinatal period experience CAD. Objective: We assessed whether there were differences in symptom trajectories in pregnant participants with CAD as compared to those with depression only (ie, major depressive disorder [MDD]) during intervention with a BA mobile gaming app. Methods: Pregnant adults with either CAD (n=10) or MDD (n=7) used a BA app for 10 weeks and completed biweekly symptom severity questionnaires for depression and anxiety. We assessed whether baseline diagnoses were associated with differential symptom trajectories across the study with mixed effects longitudinal models. Results: When controlling for baseline symptoms, results revealed a significant interaction between baseline diagnosis and the quadratic component of study week on anxiety (β=.18, SE 0.07; t₆₂=2.61; P=.01), revealing a tendency for anxiety in the CAD group to increase initially and then decrease at an accelerated rate, whereas MDD symptoms were relatively stable across time. There was a significant effect of linear time on depression (β=−.39, SE 0.11; t₆₈=−3.51; P=.001), showing that depression declined steadily across time for both groups. There was a significant effect of baseline diagnosis on depression (β=−8.53, SE 3.93; t₁₃=−2.17; P=.05), suggesting that those with MDD had higher follow-up depression compared to those with CAD when holding other predictors constant. Conclusions: The app was beneficial in reducing depression symptoms in perinatal individuals with different comorbidity profiles. With respect to anxiety symptom trajectories, however, there was more variability. The app may be especially effective for the treatment of anxiety symptoms among individuals with CAD, as it encourages in-the-moment ecologically relevant exposure to anxiety-provoking stimuli. Despite no significant group difference in baseline anxiety symptoms, the MDD group did not have a significant reduction in their anxiety symptoms across the study period, and some individuals had an increase in anxiety. Findings may point to opportunities for the augmentation of BA gaming apps for those with MDD to more effectively target anxiety symptoms. Overall, findings suggest there may be value in considering comorbidities and individual variations in participants when developing scalable mobile interventions for perinatal populations.

BACKGROUND Mobile Behavioral Activation (BA) is efficacious for the treatment of perinatal depression, however, the effect of comorbidity on symptom trajectories remains underexplored which is important given that at least 10% of women in the perinatal period experience comorbid anxiety and depression (CAD). OBJECTIVE Our objective was to assess whether there are differences in symptom trajectories in pregnant participants with Comorbid Anxiety and Depression (CAD) as compared to those same with depression only (i.e., Major Depressive Disorder; MDD) during intervention with a Behavioral Activation (BA) mobile gaming app. METHODS Pregnant adults with either CAD (n = 10) or MDD (n = 7) used a BA app for 10 weeks and completed biweekly symptom severity questionnaires for depression and anxiety. We assessed whether baseline diagnoses were associated with differential symptom trajectories across the study with mixed effects longitudinal models. RESULTS When controlling for baseline symptoms, results revealed a significant interaction between baseline diagnosis and the quadratic component of study week on anxiety (β = 0.06, SE = 0.02, t(63) = 2.94, p = .005), revealing a tendency for anxiety in CAD group to increase initially and then decrease at an accelerated rate, whereas MDD symptoms were relatively stable across time. There was a significant effect of linear time on PHQ-9 (β = -0.39, SE = 0.11, t(68) = -3.51, p = .001), showing that PHQ-9 declined steadily across time for both groups. There was a significant effect of baseline diagnosis on PHQ-9 (β = -8.53, SE = 3.93, t(13) = -2.17, p = .05), suggesting that those with MDD had higher PHQ-9 scores post- treatment compared to those with CAD when holding other predictors constant. CONCLUSIONS Findings underscore the need to consider comorbidities and individual variations in participants when developing scalable mobile interventions for perinatal populations. CLINICALTRIAL Not applicable

Background: Depression during pregnancy is increasingly recognized as a worldwide public health problem. If untreated, there can be detrimental outcomes for the mother and child. Anxiety is also often comorbid with depression. Although effective treatments exist, most women do not receive treatment. Technology is a mechanism to increase access to and engagement in mental health services. Objective: The Guardians is a mobile app, grounded in behavioral activation principles, which seeks to leverage mobile game mechanics and in-game rewards to encourage user engagement. This study seeks to assess app satisfaction and engagement and to explore changes in clinical symptoms of depression and anxiety among a sample of pregnant women with elevated depressive symptoms. Methods: This multimethod pilot test consisted of a single-arm, proof-of-concept trial to examine the feasibility and acceptability of The Guardians among a pregnant sample with depression (N=18). Participation included two web-based study visits: (1) a baseline assessment to collect demographic and obstetric information and to assess clinical symptoms and (2) an exit interview to administer follow-up measures and explore user experience. Participants completed biweekly questionnaires (ie, Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7) during the trial to assess depression and anxiety symptom severity. App satisfaction was measured using 2 self-report scales (ie, Mobile Application Rating Scale and Player Experience of Needs Satisfaction scale). Engagement with The Guardians was captured using game interaction metric data. We used backward-eliminated mixed effects longitudinal models to examine the effects of app engagement and satisfaction and length of time in the study on symptoms of depression and anxiety. Content analysis was conducted on qualitative data from exit interviews. Results: The 15-day and 30-day overall app retention rates were 26.6% and 15.1%, respectively. Mixed effects models found significant negative main effects of week in study (β=−.35; t61=−3.05; P=.003), number of activities completed (β=−.12; t61=−2.05; P=.04), days played (β=−.12; t58=−2.9; P=.005), and satisfaction, according to the Mobile Application Rating Scale (β=−3.05; t45=−2.19; P=.03) on depressive symptoms. We have reported about similar analyses for anxiety. There is preliminary evidence suggesting harder activities are associated with greater mood improvement than easier activities. Qualitative content analysis resulted in feedback falling under the following themes: activities, app design, engagement, fit of the app with lifestyle, perceived impact of the app on mood, and suggestions for app modifications. Conclusions: Preliminary results from this multimethod study of The Guardians indicate feasibility and acceptability among pregnant women with depression. Retention and engagement levels were more than double those of previous public mental health apps, and use of the app was associated with significant decrease in depressive symptom scores over the 10-week trial. The Guardians shows promise as an effective and scalable digital intervention to support women experiencing depression.

BACKGROUND Depression during pregnancy is increasingly recognized as a worldwide public health problem. If untreated, there can be detrimental outcomes for the mother and child. Anxiety is also often comorbid with depression. Although effective treatments exist, most women do not receive treatment. Technology is a mechanism to increase access to and engagement in mental health services. OBJECTIVE The Guardians is a mobile app, grounded in behavioral activation principles, which seeks to leverage mobile game mechanics and in-game rewards to encourage user engagement. This study seeks to assess app satisfaction and engagement and to explore changes in clinical symptoms of depression and anxiety among a sample of pregnant women with elevated depressive symptoms. METHODS This multimethod pilot test consisted of a single-arm, proof-of-concept trial to examine the feasibility and acceptability of The Guardians among a pregnant sample with depression (N=18). Participation included two web-based study visits: (1) a baseline assessment to collect demographic and obstetric information and to assess clinical symptoms and (2) an exit interview to administer follow-up measures and explore user experience. Participants completed biweekly questionnaires (ie, Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7) during the trial to assess depression and anxiety symptom severity. App satisfaction was measured using 2 self-report scales (ie, Mobile Application Rating Scale and Player Experience of Needs Satisfaction scale). Engagement with The Guardians was captured using game interaction metric data. We used backward-eliminated mixed effects longitudinal models to examine the effects of app engagement and satisfaction and length of time in the study on symptoms of depression and anxiety. Content analysis was conducted on qualitative data from exit interviews. RESULTS The 15-day and 30-day overall app retention rates were 26.6% and 15.1%, respectively. Mixed effects models found significant negative main effects of week in study (β=−.35; t61=−3.05; P=.003), number of activities completed (β=−.12; t61=−2.05; P=.04), days played (β=−.12; t58=−2.9; P=.005), and satisfaction, according to the Mobile Application Rating Scale (β=−3.05; t45=−2.19; P=.03) on depressive symptoms. We have reported about similar analyses for anxiety. There is preliminary evidence suggesting harder activities are associated with greater mood improvement than easier activities. Qualitative content analysis resulted in feedback falling under the following themes: activities, app design, engagement, fit of the app with lifestyle, perceived impact of the app on mood, and suggestions for app modifications. CONCLUSIONS Preliminary results from this multimethod study of The Guardians indicate feasibility and acceptability among pregnant women with depression. Retention and engagement levels were more than double those of previous public mental health apps, and use of the app was associated with significant decrease in depressive symptom scores over the 10-week trial. The Guardians shows promise as an effective and scalable digital intervention to support women experiencing depression. CLINICALTRIAL

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Encouraging individuals to report daily information such as disease symptoms, daily activities and behaviors, or aspects of their physical and emotional state, is difficult, but necessary for many studies and clinical trials that rely on patient-reported data as primary outcomes. Paper diaries are the traditional method of completing daily diaries, but digital surveys are becoming the new standard because of their increased compliance; however, they still fall short of desired compliance levels. Objective: Mobile games using in-game rewards offer the opportunity to increase compliance above the rates of digital diaries and paper diaries. We conduct a 5-week randomized control trial to compare the completion rates of a daily diary across three conditions: a paper-based participant reported outcome diary (Paper PRO), an electronic-based participant reported outcome diary (ePRO), and a novel electronic-based participant reported outcome diary with in-game rewards (Game-Motivated ePRO). Methods: We developed a novel mobile game that is a combination of the idle and pet collection genres to reward individuals who complete a daily diary with an in-game reward. One hundred ninety-seven (197) individuals aged 6-24 (Male: 100, Female: 97) were enrolled in a 5-week study and randomized into one of the three methods of daily diary completion. One hundred fifty-seven (157) participants (Male: 84, Female: 69) completed at least one diary and were subsequently included in analysis of compliance rates. Results: We observed a significant difference in compliance to filling out daily diaries, with the Game-Motivated ePRO group having the highest compliance (86.4% completion), followed by the ePRO group (77.7% completion), and lastly the Paper PRO group (70.6% completion). Both the ePRO ((odds ratio: 2.04, P=0.0414) and the Game-Motivated ePRO (odds ratio: 5.17, P<.0001) significantly improved compliance rates above the Paper PRO. Additionally, the Game-Motivated ePRO resulted in higher compliance rates than the ePRO alone (odds ratio: 2.53, P=0.0144). Equally important, even though we observed significant differences in completion of daily diaries between groups, we did not observe any statistically significant differences in the types of responses to a daily mood question (all P-values >0.58), the average diary completion time (P=0.57), or the System Usability Scale (SUS) score (P=0.61). Conclusions: The Game-Motivated ePRO system encouraged individuals to complete the daily diaries above the compliance rates of the Paper PRO and ePRO without altering the participant’s responses.