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Background: Approximately 4% to 8% of pregnant individuals meet the criteria for current posttraumatic stress disorder (PTSD), a known risk factor for a multitude of adverse maternal and child health outcomes. However, PTSD is rarely detected or treated in obstetric settings. Moreover, available prenatal PTSD treatments require in-person services that are often inaccessible due to barriers to care. Thus, web-based interventions offer great potential in extending PTSD treatment to high-risk pregnant individuals by providing affordable, accessible care. However, there are currently no web-based interventions designed specifically for the treatment of PTSD symptoms during pregnancy., Objective: This study aims to develop and pilot a 6-week, web-based, cognitive behavioral therapy intervention for PTSD, SunnysideFlex, in a sample of 10 pregnant women with current probable PTSD. Consistent with established guidelines for developing and testing novel interventions, the focus of this pilot study was to evaluate the initial feasibility and acceptability of the SunnysideFlex intervention and preintervention to postintervention changes in PTSD and depression symptoms. This approach will allow for early refinement and optimization of the SunnysideFlex intervention to increase the odds of success in a larger-scale clinical trial., Methods: The SunnysideFlex intervention adapted an existing web-based platform for postpartum depression, Sunnyside for Moms, to include revised, trauma-focused content. A total of 10 pregnant women in weeks 16 to 28 of their pregnancy who reported lifetime interpersonal trauma exposure (ie, sexual or physical assault) and with current probable PTSD (scores ≥33 per the PTSD checklist for DSM-5) were enrolled in the SunnysideFlex intervention. Assessments took place at baseline and 6 weeks (postintervention)., Results: All participants were retained through the postintervention assessment period. Engagement was high; participants on average accessed 90% of their lessons, logged on to the platform at least weekly, and reported a generally positive user experience. Moreover, 80% (8/10) of participants demonstrated clinically meaningful reductions in PTSD symptoms from baseline to postintervention, and 50% (5/10) of participants no longer screened positive for probable PTSD at postintervention. Most (6/10, 60%) of the participants maintained subclinical depression symptoms from baseline to postintervention., Conclusions: Findings from this small pilot study indicate that SunnysideFlex may be a feasible and acceptable mechanism for delivering PTSD intervention to high-risk, trauma-exposed pregnant women who might otherwise not have opportunities for services. Larger-scale trials of the intervention are necessary to better understand the impact of SunnysideFlex on PTSD symptoms during pregnancy and the postpartum period., (©Katherine C Paltell, Jennifer Duffecy, Pauline M Maki, Shiva Edalatian Zakeri, Anka A Vujanovic, Erin C Berenz. Originally published in JMIR Formative Research (https://formative.jmir.org), 01.11.2024.)

Background: Passive sensing through smartphone keyboard data can be used to identify and monitor symptoms of mood disorders with low participant burden. Behavioral phenotyping based on mobile keystroke data can aid in clinical decision-making and provide insights into the individual symptoms of mood disorders., Objective: This study aims to derive digital phenotypes based on smartphone keyboard backspace use among 128 community adults across 2948 observations using a Bayesian mixture model., Methods: Eligible study participants completed a virtual screening visit where all eligible participants were instructed to download the custom-built BiAffect smartphone keyboard (University of Illinois). The BiAffect keyboard unobtrusively captures keystroke dynamics. All eligible and consenting participants were instructed to use this keyboard exclusively for up to 4 weeks of the study in real life, and participants' compliance was checked at the 2 follow-up visits at week 2 and week 4. As part of the research protocol, every study participant underwent evaluations by a study psychiatrist during each visit., Results: We found that derived phenotypes were associated with not only the diagnoses and severity of depression and mania but also specific individual symptoms. Using a linear mixed-effects model with random intercepts accounting for the nested data structure from daily data, the backspace rates on the continuous scale did not differ between participants in the healthy control and in the mood disorders groups (P=.11). The 3-class model had mean backspace rates of 0.112, 0.180, and 0.268, respectively, with a SD of 0.048. In total, 3 classes, respectively, were estimated to comprise 37.5% (n=47), 54.4% (n=72), and 8.1% (n=9) of the sample. We grouped individuals into Low, Medium, and High backspace rate groups. Individuals with unipolar mood disorder were predominantly in the Medium group (n=54), with some in the Low group (n=27) and a few in the High group (n=6). The Medium group, compared with the Low group, had significantly higher ratings of depression (b=2.32, P=.008). The High group was not associated with ratings of depression with (P=.88) or without (P=.27) adjustment for medication and diagnoses. The High group, compared with the Low group, was associated with both nonzero ratings (b=1.91, P=.02) and higher ratings of mania (b=1.46, P<.001). The High group, compared with the Low group, showed significantly higher odds of elevated mood (P=.03), motor activity (P=.04), and irritability (P<.05)., Conclusions: This study demonstrates the promise of mobile typing kinematics in mood disorder research and practice. Monitoring a single mobile typing kinematic feature, that is, backspace rates, through passive sensing imposes a low burden on the participants. Based on real-life keystroke data, our derived digital phenotypes from this single feature can be useful for researchers and practitioners to distinguish between individuals with and those without mood disorder symptoms., (©Qimin Liu, Emma Ning, Mindy K Ross, Andrea Cladek, Sarah Kabir, Amruta Barve, Ellyn Kennelly, Faraz Hussain, Jennifer Duffecy, Scott A Langenecker, Theresa M Nguyen, Theja Tulabandhula, John Zulueta, Alexander P Demos, Alex Leow, Olusola Ajilore. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 29.10.2024.)

Background: Major depressive disorder (MDD) is prevalent, yet sub-optimally treated among persons with multiple sclerosis (MS). We propose that exercise training may be a promising approach for treating depression in persons with MS who have MDD. Our primary hypothesis predicts a reduction in depression severity immediately after an exercise training intervention compared with minimal change in an attention control condition, and the reduction will be maintained during a follow-up period., Methods: This study involves a parallel-group, assessor-blinded RCT that examines the effect of a 4-month home-based exercise training intervention on depression severity in a sample of persons with MS who have MDD based on the MINI International Neuropsychiatric Interview. The primary outcomes of depression severity are the Patient Health Questionnaire-9 and Hamilton Depression Rating Scale. Participants (N = 146) will be recruited from within 200 miles of the University of Illinois at Chicago and randomized (1:1) into either a home-based exercise training condition or control condition with concealed allocation. The exercise training and social-contact, attention control (i.e., stretching) conditions will be delivered remotely over a 4-month period and supported through eight, 1:1 Zoom-based behavioral coaching sessions guided by social-cognitive theory and conducted by persons who are uninvolved in screening, recruitment, random assignment, and outcome assessment. We will collect outcome data at 0, 4 and 8 months using treatment-blinded assessors, and data analyses will involve intent-to-treat principles., Discussion: If successful, the proposed study will provide the first Class I evidence supporting a home-based exercise training program for treating MDD in persons with MS. This is critical as exercise training would likely have positive secondary effects on symptoms, cognition, and quality of life, and provide a powerful, behavioral approach for managing the many negative outcomes of MDD in MS. The program in the proposed research is accessible and scalable for broad treatment of depression in MS, and provides the potential for integration in the clinical management of MS., Trial Registration: The trial was registered on September 10, 2021 at clinicaltrials.gov with the identifier NCT05051618. The registration occurred before we initiated recruitment on June 2, 2023., (© 2024. The Author(s).)

Background: Short sleep duration, defined as < 7 h sleep on weeknights, affects 40% of the US adult population, contributing to the increased risk for cardiometabolic diseases, decreased safety, and poorer mental health. Despite the prevalence of short sleep duration, few studies have tested interventions to extend sleep duration. The objective of this study is to test the effects of a behavioral sleep extension intervention on sleep duration, blood pressure, and other measures of cardiometabolic health among adults with elevated blood pressure or hypertension., Methods: This is a single-blind, randomized controlled trial to determine the impact of a behavioral sleep extension intervention on sleep duration and cardiometabolic health among individuals with short sleep duration (< 7 h per night) and elevated blood pressure or hypertension (SBP 120-150 mmHg or DBP 80-90 mmHg). After completing the screening, participants will be randomly assigned to either a sleep coaching (intervention) or health education (control) group. The participants will have weekly contact for either coaching or education for 8 weeks (intervention period) followed by monthly coaching or education for the next 2 months (maintenance period). Participants will complete assessment visits, actigraphy, and 24-h ambulatory blood pressure recording at baseline/screening, 8 weeks, and 6 and 12 months. The primary outcome is sleep duration at 8 weeks, and the secondary outcome is blood pressure at 8 weeks., Discussion: The results of this study will determine the effects of behavioral sleep extension on sleep and cardiometabolic health among adults with short sleep duration and elevated BP/hypertension. The results will inform the feasibility and efficacy of behavioral sleep extension and provide information needed for future multi-site effectiveness studies., Trial Registration: ClinicalTrials.gov NCT04766424. Registered on 21 February 2021., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objectives: The goal of this study was to examine the contribution of sleep extension intervention components (wearable sleep tracker and coaching) on sleep extension outcomes., Patient Involvement: This study collected open ended qualitative responses of treatment preference, acceptability, and feasibility as a key outcome., Methods: Adults aged 25 to 65 years with sleep duration <7 h and BMI ≥ 25 were randomized into one of four groups: Self-Management (control), Fitbit, Telephone Coaching, or Fitbit + Coaching. Self-report questionnaires and actigraphy were completed at baseline, post-intervention (6 weeks), and 12-weeks. Analyses used mixed models., Results: Among the 38 adults randomized, the Fitbit + Coaching group had larger but non-significant improvements in sleep duration compared with the self-management group. The coaching group demonstrated significant improvements in sleep-related impairment. All groups demonstrated feasibility and acceptability but the Fitbit + Coaching group reported themes of accountability., Conclusions: Results suggest that sleep extension interventions are feasible and acceptable but components affect the pattern of sleep and other outcomes., Practical Implications: Sleep extension is feasible and acceptable; the combination of coaching and the wearable device may lead to larger changes in sleep due to enhanced accountability., Competing Interests: The authors have no conflicts of interest to declare., (© 2022 The Authors.)

Background: Fear of recurrence (FoR) is prevalent among breast cancer survivors (BCS) and may be exacerbated by avoidance coping. This study examined BCS with avoidance coping and their engagement in a FoR eHealth intervention (FoRtitude)., Methods: BCS (N = 196) with elevated FoR participated in FoRtitude. Patient-reported measures assessed avoidance coping with FoR and baseline emotional and behavioral health. Intervention engagement was measured quantitatively (e.g., website logins, telecoaching attendance) and qualitatively (i.e., telecoaching notes)., Results: 38 BCS (19%) endorsed avoidance coping, which was associated with more severe post-traumatic anxiety-related symptoms and worse global mental health (ps < .05), but not anxiety (p = .19), depression (p = .11), physical health (p = .12), alcohol consumption (p = .85), or physical activity (p = .39). Avoidance coping was not associated with engagement levels (ps > .05) but did characterize engagement-related motivators and barriers., Conclusions: Avoidance coping was not a barrier to FoRtitude engagement. eHealth delivery is a promising modality for engaging survivors with avoidance coping in FoR interventions., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Despite extensive benefits and high intentions, few mothers breastfeed exclusively for the recommended duration. Maternal mental health is an important underlying factor associated with barriers and reduced rates of breastfeeding intent, initiation, and continuation. Given evidence of a bidirectional association between maternal mental health and breastfeeding, it is important to consider both factors when examining the efficacy of interventions to improve these outcomes. The purpose of this manuscript is to review the literature on the efficacy of behavioral interventions focused on both maternal mental health and breastfeeding outcomes, examining the intersection of the two., Methods: This systematic review was completed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines. Studies were selected if they were available in English, used primary experimental design, and used a behavioral intervention type to examine maternal mental health and breastfeeding outcomes. Articles were identified from PubMed, CINAHL, Embase, and PsycINFO from database inception to 3 March 2022. Study quality was assessed using the Cochrane Risk of Bias tool. Results were synthesized by intervention success for 1. Mental health and breastfeeding, 2. Breastfeeding only, 3. Mental health only, and 4. No intervention effect. PROSPERO CRD42021224228., Results: Thirty interventions reported in 33 articles were identified, representing 15 countries. Twelve studies reported statistically significant positive effect of the intervention on both maternal mental health and breastfeeding; most showing a decrease in self-report depressive and/or anxiety symptoms in parallel to an increase in breastfeeding duration and/or exclusivity. Common characteristics of successful interventions were a) occurring across pregnancy and postpartum, b) delivered by hospital staff or multidisciplinary teams, c) offered individually, and d) designed to focus on breastfeeding and maternal mental health or on breastfeeding only. Our results are not representative of all countries, persons, experiences, circumstances, or physiological characteristics., Conclusions: Interventions that extend the perinatal period and offer individualized support from both professionals and peers who collaborate through a continuum of settings (e.g., health system, home, and community) are most successful in improving both mental health and breastfeeding outcomes. The benefits of improving these outcomes warrant continued development and implementation of such interventions., Systematic Review Registration: PROSPERO CRD42021224228., (© 2022. The Author(s).)

Background: Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life have also been linked to sleep variability and insufficient sleep duration. A significant gap of knowledge exists regarding interventions to improve sleep and the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration, and glycemic control (A1C); other glycemic parameters (glycemic variability, time-in-range [TIR]); diabetes distress; self-management behaviors; quality of life; and other patient-reported outcomes in adults with T1D and habitual increased sleep variability or short sleep duration., Methods: A randomized controlled parallel-arm study will be employed in 120 adults (aged 18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (> 1 h/week) or insufficient sleep duration (< 6.5 h per night). Eligible subjects will be randomized to the Sleep-Opt intervention group or healthy living attention control group for 12 weeks. A 1-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and TIR using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life, and additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that we recently developed that leverages the rapidly increasing public interest in sleep tracking. Our behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. Baseline measures will be repeated at midpoint, program completion, and post-program (weeks 6, 12, and 24, respectively) to determine differences between the two groups and sustainability of the intervention., Discussion: A better understanding of strategies to improve sleep in persons with T1D has the potential to be an important component of diabetes., Trial Registration: Clinical Trial Registration: NCT04506151 ., (© 2022. The Author(s).)

Objectives: Women with a history of gestational diabetes (GDM) are at 7-fold increase in the risk of developing diabetes. Insufficient sleep has also been shown to increase diabetes risk. This study aimed to explore the feasibility of a sleep extension in women with a history of GDM and short sleep, and effects on glucose metabolism., Methods: Women age 18-45 years with a history of GDM and actigraphy confirmed short sleep duration (<7 h/night) on weekdays were randomized at a ratio of 1 control (heathy living information) to 2 cases (6 weeks of "Sleep-Extend" intervention: use of a Fitbit, weekly digital content, and weekly coaching to increase sleep duration). An oral glucose tolerance test (OGTT), 7-day actigraphy recording, and questionnaires were obtained at baseline and 6 weeks. Mean differences between baseline and end-of-intervention parameters were compared using independent samples t-tests., Results: Mean (SD) sleep duration increased within the Sleep-Extend group (n=9, +26.9 (42.5) min) but decreased within the controls (n=5, - 9.1 (20.4) min), a mean difference (MD) of 35.9 min (95% confidence interval (CI) - 8.6, 80.5). Fasting glucose increased, but less in Sleep-Extend vs. control groups (1.6 (9.4) vs 10.4 (8.2) mg/dL, MD - 8.8 mg/dL (95% CI - 19.8, 2.1), while 2-h glucose levels after an OGTT did not differ. Compared to controls, Sleep-Extend had decreased fatigue score (MD - 10.6, 95%CI - 20.7, - 0.6), and increased self-report physical activity (MD 5036 MET- minutes/week, 95%CI 343, 9729. Fitbit compliance and satisfaction in Sleep-Extend group was high., Conclusion: Sleep extension is feasible in women with a history of GDM, with benefits in fatigue and physical activity, and possibly glucose metabolism. These data support a larger study exploring benefits of sleep extension on glucose metabolism in these high-risk women., Trial Registration: ClinicalTrials.gov , NCT03638102 (8/20/2018)., (© 2022. The Author(s).)

Anterior cingulate cortex (ACC) response during attentional control in the context of task-irrelevant emotional faces is a promising biomarker of cognitive behavioral therapy (CBT) outcome in patients with social anxiety disorder (SAD). However, it is unclear whether this biomarker extends to major depressive disorder (MDD) and is specific to CBT outcome. In the current study, 72 unmedicated patients with SAD (n = 39) or MDD (n = 33) completed a validated emotional interference paradigm during functional magnetic resonance imaging before treatment. Participants viewed letter strings superimposed on task-irrelevant threat and neutral faces under low perceptual load (high interference) and high perceptual load (low interference). Biomarkers comprised anatomy-based rostral ACC (rACC) and dorsal ACC (dACC) response to task-irrelevant threat (>neutral) faces under low and high perceptual load. Patients were randomly assigned to 12 weeks of CBT or supportive therapy (ST) (ClinicalTrials.gov identifier: NCT03175068). Clinician-administered measures of social anxiety and depression severity were obtained at baseline and every 2 weeks throughout treatment (7 assessments total) by an assessor blinded to the treatment arm. A composite symptom severity score was submitted to latent growth curve models. Results showed more baseline rACC activity to task-irrelevant threat>neutral faces under low, but not high, perceptual load predicted steeper trajectories of symptom improvement throughout CBT or ST. Post-hoc analyses indicated this effect was driven by subgenual ACC (sgACC) activation. Findings indicate ACC activity during attentional control may be a transdiagnostic neural predictor of general psychotherapy outcome., (© 2021. The Author(s), under exclusive licence to American College of Neuropsychopharmacology.)

Background: Mothers who identify as Black or African American are more likely to report depressed moods in late pregnancy and early postpartum and have the lowest rates of human milk feeding compared with all other racial groups in the United States. Internet interventions offer the potential to extend preventative and supportive services as they address key barriers, particularly for those navigating the complex and vulnerable early postpartum period. However, there is limited evidence on the feasibility of such interventions for preventing perinatal mental health disorders and improving human milk feeding outcomes in Black mothers., Objective: This pilot study aimed to assess the feasibility and preliminary findings of a web-based cognitive behavioral therapy-based internet intervention, with and without human milk feeding education and support, to prevent perinatal depression and promote human milk feeding in Black mothers., Methods: Participants were Black-identifying individuals between 20 and 28 weeks of pregnancy with human milk feeding intention and mild to moderate depressive symptoms (Patient Health Questionnaire scores 5-14). Participants were randomized to either Sunnyside, a 6-week cognitive behavioral therapy-based web-based intervention, or Sunnyside Plus, which included additional education and support to promote human milk feeding. Assessments occurred at baseline, third trimester (end of antenatal treatment), 6 weeks postpartum (end of postpartum treatment), and 12 weeks postpartum. The primary focus of this randomized pilot trial was the feasibility and preliminary outcomes of mental health and human milk feeding., Results: A total of 22 tertiary-educated participants were randomized. The mean number of log-ins was 7.3 (SD 5.3) for Sunnyside and 13.8 (SD 10.5) for Sunnyside Plus. Scores of depression and anxiety measures remained below the clinical threshold for referral to treatment in both groups. All the participants initiated human milk feeding (18/18, 100%). Most participants reported at least some human milk feeding at both 6 and 12 weeks postpartum (6/7, 86%; 11/11, 100%, or 10/10, 100%, for Sunnyside and Sunnyside Plus, respectively)., Conclusions: The results suggest that tertiary-educated Black mothers at risk for perinatal depression and who intended to human milk feed were receptive to and satisfied with a web-based cognitive behavioral therapy-based internet intervention, with and without human milk feeding education and support. Preliminary findings indicate that both Sunnyside and Sunnyside Plus interventions have the potential to affect symptoms of depression, anxiety, and human milk feeding outcomes., Trial Registration: ClinicalTrials.gov NCT04128202; https://www.clinicaltrials.gov/ct2/show/NCT04128202., (©Lacey Pezley, Lisa Tussing-Humphreys, Mary Dawn Koenig, Pauline Maki, Angela Odoms-Young, Sally Freels, Brittany DiPiazza, Felicity Cann, Kate Cares, Courtney Depa, Gintare Klejka, Manoela Lima Oliveira, Jilian Prough, Taylor Roe, Joanna Buscemi, Jennifer Duffecy. Originally published in JMIR Formative Research (https://formative.jmir.org), 03.05.2022.)

In an increasingly connected world and in the midst of a global pandemic, digital trials offer numerous advantages over traditional trials that rely on physical study sites. Digital trials have the potential to improve access to research and clinical treatments for the most vulnerable and minoritized, including pregnant and postpartum individuals. However, digital trials are underutilized in maternal and child health research, and there is limited evidence to inform the design and conduct of digital trials. Our research collaborative, consisting of 5 research teams in the U.S. and Australia, aimed to address this gap. We collaborated to share lessons learned from our experiences recruiting and retaining pregnant and postpartum individuals in digital trials of social and behavioral interventions. We first discuss the promise of digital trials in improving participation in research during the perinatal period, as well as the unique challenges they pose. Second, we present lessons learned from 12 completed and ongoing digital trials that have used platforms such as Ovia, Facebook, and Instagram for recruitment. Our trials evaluated interventions for breastfeeding, prenatal and postpartum depression, insomnia, decision making, and chronic pain. We focus on challenges and lessons learned in 3 key areas: (1) rapid recruitment of large samples with a diversity of minoritized identities, (2) retention of study participants in longitudinal studies, and (3) prevention of fraudulent enrollment. We offer concrete strategies that we pilot-tested to address these challenges. Strategies presented in this commentary can be incorporated, as well as formally evaluated, in future studies., (©Amanda M Parks, Jennifer Duffecy, Jennifer E McCabe, Rachel Blankstein Breman, Jeannette Milgrom, Yafit Hirshler, Alan W Gemmill, Lisa S Segre, Jennifer N Felder, Lori Uscher-Pines. Originally published in JMIR Pediatrics and Parenting (https://pediatrics.jmir.org), 20.04.2022.)

Background: Fear of recurrence (FoR) is a prevalent concern among breast cancer survivors (BCS), yet few accessible interventions exist. This study evaluated a targeted eHealth intervention, "FoRtitude," to reduce FoR using cognitive behavioral skills training and telecoaching., Methods: BCS (N  = 196) were recruited from an academic medical center and 3 National Cancer Institute Community Oncology Research Program community sites, had stage 0-III breast cancer, were 1-10 years postprimary treatment, with moderate to high FoR and familiarity with the internet. Using the Multiphase Optimization Strategy, participants were independently randomly assigned to 3 cognitive behavioral skills (relaxation, cognitive restructuring, worry practice) vs an attention control condition (health management content [HMC]) and to telecoaching (motivational interviewing) vs no telecoaching. Website content was released across 4 weeks and included didactic lessons, interactive tools, and a text-messaging feature. BCS completed the Fear of Cancer Recurrence Inventory at baseline and at 4 and 8 weeks. Fear of Cancer Recurrence Inventory scores over time were compared using mixed-effects models. All statistical tests were 2-sided., Results: FCRI scores [SD] decreased statistically significantly from baseline to postintervention (T0 = 53.1 [17.4], T2 = 41.9 [16.2], P < .001). The magnitude of reduction in FCRI scores was comparable across cognitive behavior therapy (CBT) and attention control HMC conditions and was predicted by increased self-efficacy. Telecoaching was associated with lower attrition and greater website use (mean adherence score [SD] = 26.6 [7.2] vs 21.0 [10.5], P < .001)., Conclusions: BCS experienced statistically significant reductions in FoR postintervention, but improvements were comparable between CBT and attention controls. Telecoaching improved adherence and retention. Future research is needed on optimal integration of CBT and HMC, dose, and features of eHealth delivery that contributed to reducing FoR. In the COVID-19 era, remote delivery has become even more essential for reaching survivors struggling with FoR., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Despite effective pharmacological treatment, bipolar disorder is a leading cause of disability due to recurrence of episodes, long episode durations, and persistence of interepisode symptoms. While adding psychotherapy to pharmacotherapy improves outcomes, the availability of adjunctive psychotherapy is limited. To extend the accessibility and functionality of psychotherapy for bipolar disorder, we developed LiveWell, a smartphone-based self-management intervention. Unfortunately, many mental health technology interventions suffer from high attrition rates, with users rapidly failing to maintain engagement with the intervention technology. Human support reduces this commonly observed engagement problem but does not consistently improve clinical and recovery outcomes. To facilitate ongoing efforts to develop human support for digital mental health technologies, this paper describes the design decisions, theoretical framework, content, mode, timing of delivery, and the training and supervision for coaching support of the LiveWell technology. This support includes clearly defined and structured roles that aim to encourage the use of the technology, self-management strategies, and communication with care providers. A clear division of labor is established between the coaching support roles and the intervention technology to allow lay personnel to serve as coaches and thereby maximize accessibility to the LiveWell intervention., (©Cynthia A Dopke, Alyssa McBride, Pamela Babington, Geneva K Jonathan, Tania Michaels, Chloe Ryan, Jennifer Duffecy, David C Mohr, Evan H Goulding. Originally published in JMIR Formative Research (http://formative.jmir.org), 24.03.2021.)

Objective: Ubiquitous technologies can be leveraged to construct ecologically relevant metrics that complement traditional psychological assessments. This study aims to determine the feasibility of smartphone-derived real-world keyboard metadata to serve as digital biomarkers of mood., Materials and Methods: BiAffect, a real-world observation study based on a freely available iPhone app, allowed the unobtrusive collection of typing metadata through a custom virtual keyboard that replaces the default keyboard. User demographics and self-reports for depression severity (Patient Health Questionnaire-8) were also collected. Using >14 million keypresses from 250 users who reported demographic information and a subset of 147 users who additionally completed at least 1 Patient Health Questionnaire, we employed hierarchical growth curve mixed-effects models to capture the effects of mood, demographics, and time of day on keyboard metadata., Results: We analyzed 86 541 typing sessions associated with a total of 543 Patient Health Questionnaires. Results showed that more severe depression relates to more variable typing speed (P < .001), shorter session duration (P < .001), and lower accuracy (P < .05). Additionally, typing speed and variability exhibit a diurnal pattern, being fastest and least variable at midday. Older users exhibit slower and more variable typing, as well as more pronounced slowing in the evening. The effects of aging and time of day did not impact the relationship of mood to typing variables and were recapitulated in the 250-user group., Conclusions: Keystroke dynamics, unobtrusively collected in the real world, are significantly associated with mood despite diurnal patterns and effects of age, and thus could serve as a foundation for constructing digital biomarkers., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV). A major gap exists in how to manage FOH. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1D to reduce or delay diabetes complications and improve quality of life. We aim to (1) determine the feasibility and acceptability of an eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention in young adults with T1D who experience FOH; and (2) determine the impact of the FREE intervention, compared to an attention control group, on the outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings)., Methods/design: A randomized controlled trial in 50 young adults aged 18 to 35 years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups., Discussion: Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV., Trial Registration: ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018.

Study Objectives: Short sleep duration contributes to hypertension, yet few behavioral sleep extension interventions have been developed. The goal of our study was to evaluate the feasibility and preliminary efficacy of a technology assisted sleep extension intervention among individuals with prehypertension/stage 1 hypertension on sleep, blood pressure and patient reported outcomes., Methods: Adults aged 30-65 with 24h ambulatory blood pressure (ABP) > 120/80 mmHg and average weekday sleep duration < 7 h/night were randomized 2:1 to a 6-week technology assisted intervention versus a self-management control group. The intervention included a wearable sleep tracker, smartphone application, weekly didactic lessons and brief telephone coaching. The control group was instructed to maintain their current sleep schedule. Data were analyzed using descriptive statistics and nonparametric statistics to evaluate differences in between groups as well as prepost changes within each group. We also conducted bivariate correlations to evaluate predictors of change in sleep and ABP., Results: A total of 16 adults were randomized into the study (11 intervention, 5 control group, 8 women, mean age 45.8 years, standard deviation 9.8 years.) Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time (P = .027), reductions in 24-hour systolic blood pressure (P = .013) and diastolic blood pressure (P = .026), improvements in sleep disturbance (P = .003) and sleep-related impairment (P = .008). Participants in the intervention group completed 90% of the coaching sessions and rated the enjoyment of the intervention as 4 or 5 out of 5., Conclusions: Technology assisted sleep extension intervention is feasible and well liked in this population. Results demonstrate the potential for this intervention to improve sleep duration, quality and 24-hour ABP., (© 2019 American Academy of Sleep Medicine.)

Study Objectives: Over one-third of the United States population sleeps less than the recommended 7 hours a night, which increases risk for chronic diseases. The aim of this study was to evaluate the acceptability of sleep extension interventions and preferences in sleep extension interventions among adults with short sleep duration., Methods: Participants aged 18 to 65 years with self-reported sleep duration ≤ 6.5 hours completed an online survey including reported sleep behaviors, barriers to adequate sleep, interest in sleep extension interventions, and a sleep disturbance questionnaire. Data were analyzed using chi-square and binary logistic regression., Results: Participants (n = 92; 61 females; mean age = 45.6 years, standard deviation = 13.5) reported an average sleep duration of 5:49 (standard deviation = 0:49). More than half of the participants reported current health comorbidities (64%), including insomnia (n = 12, 13%) and sleep apnea (n = 9, 10%). Many participants (38%) reported sleep disturbance. The most common barrier to adequate sleep included insomnia or other sleep problems (55%). Most respondents (84%) indicated an interest in increasing sleep duration. Of the treatment options suggested, most (84% of those interested) were interested in a wrist-worn device. Participants with insomnia or other sleep disorders were more likely to be interested in extending sleep, (χ² = 12.86, P < .001) and in a wrist-worn device (χ² = 5.24, P = .022). Higher Patient-Reported Outcomes Measurement Information System sleep disturbance t scores were also associated with interest in monitoring sleep with a wrist-worn device (b = .18, P < .001)., Conclusions: Sleep extension interventions using wearable technology are attractive to individuals with short sleep duration, particularly those with greater sleep disturbance and comorbid sleep disorders., Citation: Adkins EC, DeYonker O, Duffecy J, Hooker SA, Baron KG. Predictors of intervention interest among individuals with short sleep duration. JClin SleepMed. 2019;15(8):1143-1148., (© 2019 American Academy of Sleep Medicine.)

Background: Postpartum depression (PPD) has a 20% 3-month prevalence rate. The consequences of PPD are significant for the mother, infant, and the family. There is a need for preventive interventions for PPD, which are effective and accessible; however, many barriers exist for women who attempt to access perinatal depression prevention programs. Internet interventions for the treatment and prevention of depression are widely accepted as efficacious and may overcome some of the issues pertaining to access to treatment barriers perinatal women face. However, internet interventions offered without any human support tend to have low adherence but positive outcomes for those who do complete treatment. Internet support groups often have high levels of adherence but minimal data supporting efficacy as a treatment for depression. Taken together, these findings suggest that combining the treatment components of individual interventions with the support provided by an internet support group might create an intervention with the scalability and cost-effectiveness of an individual intervention and the better outcomes typically found in supported interventions., Objectives: This study aimed to describe the development of a cognitive behavioral therapy (CBT) internet intervention with peer support to prevent PPD and examine preliminary depression and site usage outcomes., Methods: User-centered design groups were used to develop the internet intervention. Once the intervention was developed, women who were 20 to 28 weeks pregnant with symptoms of depression (Patient Health Questionnaire-8 scores of 5-14) but who had no major depression diagnosis were enrolled in a randomized controlled trial (RCT) to compare 8 weeks of a CBT-based internet intervention with peer support to an individual internet intervention designed to prevent PPD. Assessments took place at baseline, 4 weeks, 8 weeks (end of treatment), and then 4 weeks and 6 weeks postpartum., Results: A total of 25 women were randomized. Of these, 24 women completed the RCT. Patient Health Questionnaire-9 scores at 6 weeks postpartum remained below the clinical threshold for referral for treatment in both groups, with depression measures showing a decrease in symptoms from baseline to postpartum. At 6 weeks postpartum, only 4% (1/24) met the criteria for PPD. There was no difference between groups in adherence to the intervention, with an average of 14.55 log-ins over the course of treatment., Conclusions: Results suggest women were responsive to both peer support and individual internet interventions to prevent PPD and that peer support may be a useful feature to keep participants adherent., Trial Registration: ClinicalTrials.gov NCT02121015; https://clinicaltrials.gov/ct2/show/NCT02121015 (archived by WebCite at http://www.webcitation.org/765a7qBKy)., (©Jennifer Duffecy, Rebecca Grekin, Hannah Hinkel, Nicholas Gallivan, Graham Nelson, Michael W O'Hara. Originally published in JMIR Mental Health (http://mental.jmir.org), 28.05.2019.)

Background: Development of psychosocial group interventions for ovarian cancer survivors has been limited. Drawing from elements of cognitive-behavioral stress management (CBSM), mindfulness-based stress reduction (MBSR), and acceptance and commitment therapy (ACT), we developed and conducted preliminary testing of an Internet-based group intervention tailored specifically to meet the needs of ovarian cancer survivors. The Internet-based platform facilitated home delivery of the psychosocial intervention to a group of cancer survivors for whom attending face-to-face programs could be difficult given their physical limitations and the small number of ovarian cancer survivors at any one treatment site., Objective: The aim of this study was to develop, optimize, and assess the usability, acceptability, feasibility, and preliminary intended effects of an Internet-based group stress management intervention for ovarian cancer survivors delivered via a tablet or laptop., Methods: In total, 9 ovarian cancer survivors provided feedback during usability testing. Subsequently, 19 survivors participated in 5 waves of field testing of the 10-week group intervention led by 2 psychologists. The group met weekly for 2 hours via an Internet-based videoconference platform. Structured interviews and weekly evaluations were used to elicit feedback on the website and intervention content. Before and after the intervention, measures of mood, quality of life (QOL), perceived stress, sleep, and social support were administered. Paired t tests were used to examine changes in psychosocial measures over time., Results: Usability results indicated that participants (n=9) performed basic tablet functions quickly with no errors and performed website functions easily with a low frequency of errors. In the field trial (n=19), across 5 groups, the 10-week intervention was well attended. Perceived stress (P=.03) and ovarian cancer-specific QOL (P=.01) both improved significantly during the course of the intervention. Trends toward decreased distress (P=.18) and greater physical (P=.05) and functional well-being (P=.06) were also observed. Qualitative interviews revealed that the most common obstacles participants experienced were technical issues and the time commitment for practicing the techniques taught in the program. Participants reported that the intervention helped them to overcome a sense of isolation and that they appreciated the ability to participate at home., Conclusions: An Internet-based group intervention tailored specifically for ovarian cancer survivors is highly usable and acceptable with moderate levels of feasibility. Preliminary psychosocial outcomes indicate decreases in perceived stress and improvements in ovarian cancer-specific QOL following the intervention. A randomized clinical trial is needed to demonstrate the efficacy of this promising intervention for ovarian cancer survivors., (©Ellen M Kinner, Jessica S Armer, Bonnie A McGregor, Jennifer Duffecy, Susan Leighton, Marya E Corden, Janine Gauthier Mullady, Frank J Penedo, Susan K Lutgendorf. Originally published in JMIR Cancer (http://cancer.jmir.org), 15.01.2018.)

Background: Despite the high prevalence of short sleep duration (29.2% of adults sleep <6 hours on weekdays), there are no existing theory-based behavioral interventions to extend sleep duration. The popularity of wearable sleep trackers provides an opportunity to engage users in interventions., Objective: The objective of this study was to outline the theoretical foundation and iterative process of designing the "Sleep Bunny," a technology-assisted sleep extension intervention including a mobile phone app, wearable sleep tracker, and brief telephone coaching. We conducted a two-step process in the development of this intervention, which was as follows: (1) user testing of the app and (2) a field trial that was completed by 2 participants with short sleep duration and a cardiovascular disease risk factor linked to short sleep duration (body mass index [BMI] >25)., Methods: All participants had habitual sleep duration <6.5 hours verified by 7 days of actigraphy. A total of 6 individuals completed initial user testing in the development phase, and 2 participants completed field testing. Participants in the user testing and field testing responded to open-ended surveys about the design and utility of the app. Participants in the field testing completed the Epworth Sleepiness Scale and also wore an actigraph for a 1-week baseline period and during the 4-week intervention period., Results: The feedback suggests that users enjoyed the wearable sleep tracker and found the app visually pleasing, but they suggested improvements to the notification and reminder features of the app. The 2 participants who completed the field test demonstrated significant improvements in sleep duration and daytime sleepiness., Conclusions: Further testing is needed to determine effects of this intervention in populations at risk for the mental and physical consequences of sleep loss., (©Kelly Glazer Baron, Jennifer Duffecy, Kathryn Reid, Mark Begale, Lauren Caccamo. Originally published in JMIR Mental Health (http://mental.jmir.org), 10.01.2018.)

The dissemination and implementation of evidence-based behavioral medicine interventions into real world practice has been limited. The purpose of this paper is to discuss specific limitations of current behavioral medicine research within the context of the RE-AIM framework, and potential opportunities to increase public health impact by applying novel intervention designs and data collection approaches. The MOST framework has recently emerged as an alternative approach to development and evaluation that aims to optimize multicomponent behavioral and bio-behavioral interventions. SMART designs, imbedded within the MOST framework, are an approach to optimize adaptive interventions. In addition to innovative design strategies, novel data collection approaches that have the potential to improve the public-health dissemination include mHealth approaches and considering environment as a potential data source. Finally, becoming involved in advocacy via policy related work may help to improve the impact of evidence-based behavioral interventions. Innovative methods, if increasingly implemented, may have the ability to increase the public health impact of evidence-based behavioral interventions to prevent disease.

Background: Depression during adolescence is common but can be prevented. Behavioral intervention technologies (BITs) designed to prevent depression in adolescence, especially standalone web-based interventions, have shown mixed outcomes, likely due to poor intervention adherence. BIT research involving adults has shown that the presence of coaches or peers promotes intervention use. Developmentally, adolescence is a time when peer-based social relationships take precedence. This study examines whether peer-networked support may promote adherence to BITs in this age group., Objective: Adopting the framework of the Supportive Accountability model, which defines the types of human support and interactions required to maintain engagement and persistence with BITs, this paper presents a feasibility study of a peer-networked online intervention for depression prevention among adolescents. We described the development of the peer network, the evaluation of participant use of the peer networking features, and qualitative user feedback to inform continued BIT development., Method: Two groups of adolescents (N = 13) participated in 10-week programs of the peer networked based online intervention. Adolescents had access to didactic lessons, CBT based mood management tools, and peer networking features. The peer networking features are integrated into the site by making use expectations explicit, allow network members to monitor the activities of others, and to supportively hold each other accountable for meeting use expectations. The study collected qualitative feedback from participants as well as usage of site features and tools., Results: Participants logged in an average of 12.8 sessions over an average of 10.4 unique days during the 10-week program. On average, 66% of all use sessions occurred within the first 3 weeks of use. The number of "exchange comments", that is, comments posted that were part of an exchange between two or more participants, was significantly positively correlated with mean time spent on site ( r = 0.62, p = 0.032), use of the Activity Tracker ( r = 0.70, p = 0.012) and Didactic Lesson ( r = 0.73, p = 0.007). Qualitative interviews revealed that adolescents generally liked and were motivated by the peer networking features during the first weeks of the intervention when general site use by group members was high. However, the decrease of site use by group members during the subsequent weeks negatively affected participants' desire to log on or engage with group members., Conclusions: This pilot study highlights the potential that a BIT designed to harness the connection among a peer network, thereby promoting supportive accountability, may improve adolescent adherence to BITs for depression prevention.

Background: Major depressive disorder is a common psychological problem affecting up to 20% of adults in their lifetime. The majority of people treated for depression receive antidepressant medication through their primary care physician. This commonly results in low rates of recovery. Failure points in the process of care contributing to poor outcomes include patient non-adherence to medications, failure of physicians to optimize dose and absence of communication between patients and physicians., Objective: This pilot study evaluated the feasibility of a systemic digital intervention (MedLink) designed to address failure points and improve treatment of depression in primary care among patients during the first eight weeks of initiating a new course of antidepressant therapy., Methods: Participants were provided with the MedLink mobile app that provided dose reminders, information and surveys of symptoms and side effects. A cellularly enabled pillbox monitored antidepressant medication adherence. Reports were provided to physicians and participants to prompt changes in medication regimen. Study outcomes were assessed via self-report and interview measures at baseline, week 4 and week 8., Results: Medication adherence detected by the MedLink system was 82%. Participants demonstrated significant decreases in depressive symptoms on the patient health questionnaire-9 (PHQ-9) ( p  = 0.0005) and the Quick Inventory of Depressive Symptomatology ( p  = 0.0008) over the eight-week trial. Usability was generally rated favorably., Conclusions: The MedLink system demonstrated promise as an intervention to address failure points in the primary care treatment of major depressive disorder. Current findings support the further development of MedLink through a randomized controlled trial to evaluate the efficacy of improving processes of care, patient adherence and symptoms of depression., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Early detection of melanoma improves survival. Since many melanoma patients and their spouses seek the care of a physician after discovering their melanoma, an ongoing study will determine the efficacy of teaching at-risk melanoma patients and their skin check partner how to conduct skin self-examinations (SSEs). Internet-based health behavior interventions have proven efficacious in creating behavior change in patients to better prevent, detect, or cope with their health issues. The efficacy of electronic interactive SSE educational intervention provided on a tablet device has not previously been determined., Objective: The electronic interactive educational intervention was created to develop a scalable, effective intervention to enhance performance and accuracy of SSE among those at-risk to develop melanoma. The intervention in the office was conducted using one of the following three methods: (1) in-person through a facilitator, (2) with a paper workbook, or (3) with a tablet device used in the clinical office. Differences related to method of delivery were elucidated by having the melanoma patient and their skin check partner provide a self-report of their confidence in performing SSE and take a knowledge-based test immediately after receiving the intervention., Methods: The three interventions used 9 of the 26 behavioral change techniques defined by Abraham and Michie to promote planning of monthly SSE, encourage performing SSE, and reinforce self-efficacy by praising correct responses to knowledge-based decision making and offering helpful suggestions to improve performance. In creating the electronic interactive SSE educational intervention, the educational content was taken directly from both the scripted in-person presentation delivered with Microsoft PowerPoint by a trained facilitator and the paper workbook training arms of the study. Enrollment totaled 500 pairs (melanoma patient and their SSE partner) with randomization of 165 pairs to the in-person, 165 pairs to the workbook, and 70 pairs to electronic interactive SSE educational intervention., Results: The demographic survey data showed no significant mean differences between groups in age, education, or income. The tablet usability survey given to the first 30 tablet pairs found that, overall, participants found the electronic interactive intervention easy to use and that the video of the doctor-patient-partner dialogue accompanying the dermatologist's examination was particularly helpful in understanding what they were asked to do for the study. The interactive group proved to be just as good as the workbook group in self-confidence of scoring moles, and just as good as both the workbook and the in-person intervention groups in self-confidence of monitoring their moles. While the in-person intervention performed significantly better on a skill-based quiz, the electronic interactive group performed significantly better than the workbook group. The electronic interactive and in-person interventions were more efficient (30 minutes), while the workbook took longer (45 minutes)., Conclusions: This study suggests that an electronic interactive intervention can deliver skills training comparable to other training methods, and the experience can be accommodated during the customary outpatient office visit with the physician. Further testing of the electronic interactive intervention's role in the anxiety of the pair and pair-discovered melanomas upon self-screening will elucidate the impact of these tools on outcomes in at-risk patient populations., Trial Registration: ClinicalTrials.gov NCT01013844; http://clinicaltrials.gov/show/NCT01013844 (Archived by WebCite at http://www.webcitation.org/6LvGGSTKK).

Background: Web-based interventions for depression that are supported by coaching have generally produced larger effect-sizes, relative to standalone web-based interventions. This is likely due to the effect of coaching on adherence. We evaluated the efficacy of a manualized telephone coaching intervention (TeleCoach) aimed at improving adherence to a web-based intervention (moodManager), as well as the relationship between adherence and depressive symptom outcomes., Methods: 101 patients with MDD, recruited from primary care, were randomized to 12 weeks moodManager+TeleCoach, 12 weeks of self-directed moodManager, or 6 weeks of a waitlist control (WLC). Depressive symptom severity was measured using the PHQ-9., Results: TeleCoach+moodManager, compared to self-directed moodManager, resulted in significantly greater numbers of login days (p = 0.01), greater time until last use (p = 0.007), greater use of lessons (p = 0.03), greater variety of interactive tools used (p = 0.02), but total instances of tool use did not reach statistical significance. (p = 0.07). TeleCoach+moodManager produced significantly lower PHQ-9 scores relative to WLC at week 6 (p = 0.04), but there were no other significant differences in PHQ-9 scores at weeks 6 or 12 (ps>0.20) across treatment arms. Baseline PHQ-9 scores were no significantly related to adherence to moodManager., Conclusions: TeleCoach produced significantly greater adherence to moodManager, relative to self-directed moodManager. TeleCoached moodManager produced greater reductions in depressive symptoms relative to WLC, however, there were no statistically significant differences relative to self-directed moodManager. While greater use was associated with better outcomes, most users in both TeleCoach and self-directed moodManager had dropped out of treatment by week 12. Even with telephone coaching, adherence to web-based interventions for depression remains a challenge. Methods of improving coaching models are discussed., Trial Registration: Clinicaltrials.gov NCT00719979.

Background: Mobile phone sensors can be used to develop context-aware systems that automatically detect when patients require assistance. Mobile phones can also provide ecological momentary interventions that deliver tailored assistance during problematic situations. However, such approaches have not yet been used to treat major depressive disorder., Objective: The purpose of this study was to investigate the technical feasibility, functional reliability, and patient satisfaction with Mobilyze!, a mobile phone- and Internet-based intervention including ecological momentary intervention and context sensing., Methods: We developed a mobile phone application and supporting architecture, in which machine learning models (ie, learners) predicted patients' mood, emotions, cognitive/motivational states, activities, environmental context, and social context based on at least 38 concurrent phone sensor values (eg, global positioning system, ambient light, recent calls). The website included feedback graphs illustrating correlations between patients' self-reported states, as well as didactics and tools teaching patients behavioral activation concepts. Brief telephone calls and emails with a clinician were used to promote adherence. We enrolled 8 adults with major depressive disorder in a single-arm pilot study to receive Mobilyze! and complete clinical assessments for 8 weeks., Results: Promising accuracy rates (60% to 91%) were achieved by learners predicting categorical contextual states (eg, location). For states rated on scales (eg, mood), predictive capability was poor. Participants were satisfied with the phone application and improved significantly on self-reported depressive symptoms (beta(week) = -.82, P < .001, per-protocol Cohen d = 3.43) and interview measures of depressive symptoms (beta(week) = -.81, P < .001, per-protocol Cohen d = 3.55). Participants also became less likely to meet criteria for major depressive disorder diagnosis (b(week) = -.65, P = .03, per-protocol remission rate = 85.71%). Comorbid anxiety symptoms also decreased (beta(week) = -.71, P < .001, per-protocol Cohen d = 2.58)., Conclusions: Mobilyze! is a scalable, feasible intervention with preliminary evidence of efficacy. To our knowledge, it is the first ecological momentary intervention for unipolar depression, as well as one of the first attempts to use context sensing to identify mental health-related states. Several lessons learned regarding technical functionality, data mining, and software development process are discussed., Trial Registration: Clinicaltrials.gov NCT01107041; http://clinicaltrials.gov/ct2/show/NCT01107041 (Archived by WebCite at http://www.webcitation.org/60CVjPH0n).

Background: Internet interventions for depression have shown less than optimal adherence. This study describes the feasibility trial of a multimodal e-mental health intervention designed to enhance adherence and outcomes for depression. The intervention required frequent brief log-ins for self-monitoring and feedback as well as email and brief telephone support guided by a theory-driven manualized protocol., Objective: The objective of this feasibility trial was to examine if our Internet intervention plus manualized telephone support program would result in increased adherence rates and improvement in depression outcomes., Methods: This was a single arm feasibility trial of a 7-week intervention., Results: Of the 21 patients enrolled, 2 (9.5%) dropped out of treatment. Patients logged in 23.2 ± 12.2 times over the 7 weeks. Significant reductions in depression were found on all measures, including the Patient Health Questionnaire depression scale (PHQ-8) (Cohen's d = 1.96, P < .001), the Hamilton Rating Scale for Depression (d = 1.34, P < .001), and diagnosis of major depressive episode (P < .001)., Conclusions: The attrition rate was far lower than seen either in Internet studies or trials of face-to-face interventions, and depression outcomes were substantial. These findings support the feasibility of providing a multimodal e-mental health treatment to patients with depression. Although it is premature to make any firm conclusions based on these data, they do support the initiation of a randomized controlled trial examining the independent and joint effects of Internet and telephone administered treatments for depression.