Study protocol: exercise training for treating major depressive disorder in multiple sclerosis.

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.

Preferred Communication Strategies for People with Communication Disabilities in Health Care Encounters: a Qualitative Study.

BACKGROUND: People with communication disabilities (CDs), which includes disabilities in speech, language, voice and/or hearing, experience health and healthcare disparities. A barrier to accessing high-quality, equitable care is the lack of effective communication between patients and their providers. OBJECTIVE: In designing a patient-prompted tool to facilitate communication, we analyzed qualitative feedback on communication strategies and the experience of people with CDs, caregivers, and providers in healthcare encounters. We aimed to describe communication strategies that patients with CDs find most useful and optimize a tool for patients to share their communication strategy preferences during clinical encounters. While patient-provider communication is paramount in every interaction, we aimed to highlight the intricacies of optimizing communication for this population. DESIGN: We performed a qualitative study utilizing focus groups and interviews with patients with CDs, their caregivers, and healthcare providers. PARTICIPANTS: A total of 46 individuals participated in focus groups or interviews; 26 participants self-reported a CD, nine were caregivers, and 11 were providers. Participants represented diverse types of CDs, including stuttering, aphasia, hearing loss, and people with autism or cerebral palsy who use assistive technology to communicate. APPROACH: Analysis of qualitative interview and focus group data was guided by a qualitative content analysis approach. KEY RESULTS: We identified three themes: (1) While communication strategies should be individualized, participants agreed upon a consolidated list of best strategies and accommodations. We used this consolidated list to finalize tool development. (2) Patients and providers preferred disclosure of the CD and desired communication strategies before the appointment. (3) Providers often do not use communication strategies and accommodations during clinical encounters. CONCLUSIONS: For patients with CDs, it is critical to acknowledge and document the CD and individualize communication strategies during healthcare visits to facilitate communication. Studies are needed to evaluate whether improved communication strategy usage leads to improved health outcomes for this population.

Depression and anxiety symptoms across pregnancy and the postpartum in low-income Black and Latina women.

Underserved women of color experience high rates of perinatal affective disorders, but most research to date on the natural history of these disorders has been conducted on White women. The present study investigated longitudinal changes in anxiety and depression in a sample of perinatal non-Hispanic Black and Latina women. Categorical (yes/no) measures of positive anxiety and depression screens, as well as total symptom scores, were measured longitudinally across the perinatal period in 178 women (115 non-Hispanic Black, 63 Latina) using the CAT-MH™, a computerized adaptive test. Time (up to 4 visits) and race/ethnicity effects were assessed in linear mixed effects models. Rates of positive anxiety screenings were 13.6%, 3.2%, 8.5%, and 0% in Latina women and 2.6%, 4.2%, 6.1%, and 5.8% in non-Hispanic Black women in the 1st, 2nd, and 3rd trimesters, and postpartum, respectively. Rates of positive anxiety screenings overall were highest in the first trimester (OR = 0.20; 95% CI 0.04-0.98), and there was a significant time-by-race/ethnicity interaction for positive anxiety screens (OR = 8.88; 95% CI 1.42-55.51), as positive screens were most frequent in the first trimester and sharply declined for Latina women, while rates were relatively consistent across the perinatal period in non-Hispanic Black women. Rates of positive depression screens did not change over time, but there was a trend (OR = 1.93; 95% CI 0.93-4.03) for a time-by-race/ethnicity interaction in a direction similar to that seen for anxiety. The odds of positive anxiety screens vary by race/ethnicity and trimester, suggesting that anxiety screening and anxiety interventions may be most resourcefully used in the first trimester for Latina women in particular.

Using mobile health applications for the rapid recruitment of perinatal women.

This article describes how two research teams recruited participants using a mobile application for pregnant women. In both studies, a study description appeared on the home screen of a pregnancy application. Interested women were directed to a secure research website to enroll. Enrollment goals were rapidly exceeded. Both studies enrolled participants from across the USA. Demographic diversity was achieved by one study. Mobile health applications are innovative venues for recruiting research participants.

Development and Evaluation of an Online Mental Health Program for Medical Students.

OBJECTIVE: Medical school presents a time of psychological distress for many students, who are less likely than the general population to seek mental health treatment due to multiple treatment barriers. Internet-based cognitive behavioral therapy (iCBT) programs may be an acceptable option for medical students. This study aims to assess acceptability and usability of ThinkFeelDo, an iCBT program, and to examine the impact of the program on perceived stress, quality of life, and the development of cognitive and behavioral coping skills. METHOD: Fourteen medical students (M age = 25.4 years, 50% female) participated in the 6-week ThinkFeelDo program and completed baseline and end of treatment assessments. RESULTS: ThinkFeelDo was used (login M = 11.9, SD = 9.8) and was rated as somewhat useful. Participants requested further refinement of lessons to better fit the typical narrative of a medical student and endorsed interest in the program being offered at the beginning of medical school. At end of program, participants increased the frequency with which they used cognitive and behavioral coping skills, t(10) = -3.400, p = .007. CONCLUSIONS: Results of this study indicate that medical students are willing to utilize online mental health programs and may receive benefit. However, the sample was small, self-selected, and without a comparison group. Feedback collected through this study provides insight on how to effectively integrate iCBT programs into the medical school experience.

Strategies for mHealth research: lessons from 3 mobile intervention studies.

The capacity of Mobile Health (mHealth) technologies to propel healthcare forward is directly linked to the quality of mobile interventions developed through careful mHealth research. mHealth research entails several unique characteristics, including collaboration with technologists at all phases of a project, reliance on regional telecommunication infrastructure and commercial mobile service providers, and deployment and evaluation of interventions "in the wild", with participants using mobile tools in uncontrolled environments. In the current paper, we summarize the lessons our multi-institutional/multi-disciplinary team has learned conducting a range of mHealth projects using mobile phones with diverse clinical populations. First, we describe three ongoing projects that we draw from to illustrate throughout the paper. We then provide an example for multidisciplinary teamwork and conceptual mHealth intervention development that we found to be particularly useful. Finally, we discuss mHealth research challenges (i.e. evolving technology, mobile phone selection, user characteristics, the deployment environment, and mHealth system "bugs and glitches"), and provide recommendations for identifying and resolving barriers, or preventing their occurrence altogether.

FREE: A randomized controlled feasibility trial of a cognitive behavioral therapy and technology-assisted intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes.

OBJECTIVE: The purpose of this study was to test the preliminary effectiveness of a cognitive behavioral therapy intervention (Fear Reduction Efficacy Evaluation [FREE]) designed to reduce fear of hypoglycemia in young adults with type 1 diabetes. The primary outcome was fear of hypoglycemia, secondary outcomes were A1C, and glycemic variability. METHODS: A randomized clinical trial was used to test an 8-week intervention (FREE) compared to an attention control (diabetes education) in 50 young adults with type 1 diabetes who experienced fear of hypoglycemia at baseline. All participants wore a continuous glucose monitor for the 8-week study period. Self-reported fear of hypoglycemia point-of-care A1C testing, continuous glucose monitor-derived glucose variability were measured at baseline, Week 8, and Week 12 (post-program). RESULTS: Compared to controls, those participating in the FREE intervention experienced a reduction in fear of hypoglycemia (SMD B = -8.52, p = 0.021), change in A1C (SMD B = 0.04, p = 0.841) and glycemic variability (glucose standard deviation SMD B = -2.5, p = 0.545) by the end of the intervention. This represented an 8.52% greater reduction in fear of hypoglycemia. CONCLUSION: A cognitive behavioral therapy intervention (FREE) resulted in improvements in fear of hypoglycemia. CLINICALTRIALS: govNCT03549104.

Remotely-delivered exercise training program for improving physical and cognitive functions among older adults with multiple sclerosis: Protocol for an NIH stage-I randomized controlled trial.

BACKGROUND: Older adults with multiple sclerosis (MS) present with low physical activity participation, cognitive and ambulatory dysfunctions, and compromised quality of life (QOL). OBJECTIVE: We propose a NIH Stage-I, randomized controlled trial (RCT) that examines the feasibility and efficacy of a 16-week theory-based, remotely-delivered, exercise training program for improving cognitive and physical functions in older adults with MS who have moderate mobility disability without severe cognitive impairment. METHODS: This Stage-I study utilizes a parallel-group RCT design. Participants (N = 50; age ≥ 50 years) will be randomly assigned into exercise training (combined aerobic and resistance exercise) or active control (flexibility and stretching) conditions. The conditions will be undertaken within a participant's home/community over a 16-week period, and monitored remotely and supported by Zoom-based chats guided by social cognitive theory (SCT) via a behavioral coach. Participants will receive training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and SCT-based newsletters. The primary outcomes include feasibility (e.g., recruitment and retention rates), exercise behavior and physical activity; other outcomes include physical function (lower-extremity function, mobility, walking), cognition (processing speed, learning and memory, executive function), MS symptoms, QOL, and vascular function. We will collect outcome data at baseline (Week 0), post-intervention (Week 16), and follow-up (Week-32). Data analysis will follow intent-to-treat principles using linear mixed-effects models. DISCUSSION: This Stage-I trial adopts an innovative approach for exercise training via telerehabilitation and is convenient and accessible for older adults with MS. If successful, the study will provide foundations for future research using remotely-delivered exercise intervention for managing the consequences of aging with MS. TRIAL REGISTRATION NUMBER: NCT05930821.

Using a Novel Digital Go/No-Go to Dissociate Intra-subject Temporal Fluctuations in Reaction Time and Accuracy.

Impulsivity can be a risk factor for serious complications for those with mood disorders. To understand intra-individual impulsivity variability, we analyzed longitudinal data of a novel gamified digital Go/No-Go (GNG) task in a clinical sample (n=43 mood disorder participants, n=17 healthy controls) and an open-science sample (n=121, self-reported diagnoses). With repeated measurements within-subject, we disentangled two aspects of GNG: reaction time and accuracy in response inhibition (i.e., incorrect No-Go trials) with respect to diurnal and potential learning effects. Mixed-effects models showed diurnal effects in reaction time but not accuracy, with a significant effect of hour on reaction time in the clinical sample and the open-science sample. Moreover, subjects improved on their response inhibition but not reaction time. Additionally, significant interactions emerged between depression symptom severity and time-of-day in both samples, supporting that repeated administration of our GNG task can yield mood-dependent circadian rhythm-aware biomarkers of neurocognitive function.

Project onward: an innovative e-health intervention for cancer survivors.

OBJECTIVE: This study examined the feasibility and acceptability of an Individual Internet Intervention (III) embedded and integrated into an Internet Support Group (ISG) with the ultimate goal of enhancing adherence and learning, compared with an individual internet invention alone. METHOD: Thirty-one posttreatment cancer survivors were randomized in groups of seven to nine to either the 8-week III + ISG intervention or the 8-week III condition. Seventeen participants met the Hospital Anxiety and Depression Scale (HADS) criteria for depressive symptoms (HADS ≥ 8). RESULTS: Among all participants, the mean number of logins over 8 weeks was 20.8 ± 17.7 logins for the III + ISG compared with 12.5 ± 12.5 in III-only (p = 0.15). Two participants in the III + ISG dropped out, compared with five in III (p = 0.39). Among the 17 participants with depressive symptoms at baseline, both the Onward and the III-only condition showed large reductions in the depression scale of HADS (d = 1.27 and 0.89, respectively). Improvement over time and time x treatment effects only reached trend significance levels (ps = 0.07 & 0.12) as this pilot was not powered to detect these differences. CONCLUSION: Both the III + ISG and III-only demonstrated pre-post reductions in depressive symptoms and high rates of utilization compared with other web-based treatments for depression. Although it is premature to make any determination as to the efficacy of the interventions tested in this feasibility study, these results indicate that pursuing the III + ISG model, as well as standard IIIs, may be fruitful areas of future research.

Multiple sclerosis and anxiety: Is there an untapped opportunity for exercise?

BACKGROUND: Anxiety symptoms and anxiety disorders are prevalent and burdensome, yet poorly managed in multiple sclerosis (MS). Indeed, anxiety disorders occur in 22% of people with MS, and anxiety can negatively impact physical function, cognition, and quality of life. Currently, there are no treatment guidelines available for anxiety in MS, based on limited information regarding the efficacy of pharmacotherapy and psychotherapy. Exercise training may be a promising avenue for treatment of anxiety in MS, and this is based, in part, on a wealth of evidence in the general population of adults. This review provides an overview of anxiety and evidence from meta-analyses and systematic reviews for current treatments options in the general population and MS. We further make a case for exercise as a novel treatment approach that requires focal examination in persons with MS. METHODS: We conducted a scoping review of available research, including systematic reviews and meta-analyses, on anxiety and its prevalence, predictors, consequences, and treatments in MS. We then noted limitations with existing evidence regarding treatment options, and then provided a backdrop based on evidence from the general population for the novel proposition of exercise as treatment of anxiety in MS. RESULTS: Pharmacotherapy and psychotherapy treatments of anxiety may be efficacious, but come with significant limitations, especially for persons with MS. Exercise is a promising novel avenue for treatment of anxiety in MS, and has a positive side-effect profile. CONCLUSION: Anxiety is under-investigated and poorly treated in MS. There is a paucity of evidence for the relationship between exercise training and anxiety in MS, but the evidence in the general population supports the urgent need for systematic examination of the efficacy of exercise in treating anxiety symptoms and disorders in persons with MS.

A feasibility study to understand the components of behavioral sleep extension.

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.

Perinatal mental health in low-income urban and rural patients: The importance of screening for comorbidities.

OBJECTIVE: To assess the rates and feasibility of assessing comorbid mental health disorders and referral rates in low-income urban and rural perinatal patients. METHODS: In two urban and one rural clinic serving primarily low-income perinatal patients of color, a computerized adaptive diagnostic tool CAT-MH® was implemented to assess major depressive disorder (MDD), general anxiety disorder (GAD), suicidality (SS), substance use disorder (SUD), and post-traumatic stress disorder (PTSD) at the first obstetric visit and/or 8 weeks postpartum. RESULTS: Of a total of 717 screens, 10.7% (n = 77 unique patients) were positive for one or more disorders (6.1% one, 2.5% two, 2.1% three or more). MDD was the most common disorder (9.6%) and was most commonly comorbid with GAD (33% of MDD cases), SUD (23%), or PTSD (23%). For patients with a positive screen, referral to treatment was 35.1% overall, with higher rates in urban (51.6%) versus rural (23.9%) clinics (p = 0.03). CONCLUSION: Mental health comorbidities are common in low-income urban and rural populations, but referral rates are low. Promoting mental health in these populations requires comprehensive screening and treatment approaches for psychiatric comorbidities and dedication to increase the availability of mental health prevention and treatment options.

Sleep-Opt-In: A Randomized Controlled Pilot Study to Improve Sleep and Glycemic Variability in Adults With Type 1 Diabetes.

PURPOSE: The purpose of this study was to evaluate the feasibility and acceptability of a technology-assisted behavioral sleep intervention (Sleep-Opt-In) and to examine the effects of Sleep-Opt-In on sleep duration and regularity, glucose indices, and patient-reported outcomes. Short sleep duration and irregular sleep schedules are associated with reduced glycemic control and greater glycemic variability. METHODS: A randomized controlled parallel-arm pilot study was employed. Adults with type 1 diabetes (n = 14) were recruited from the Midwest and randomized 3:2 to the sleep-optimization (Sleep-Opt-In) or Healthy Living attention control group. Sleep-Opt-In was an 8-week, remotely delivered intervention consisting of digital lessons, sleep tracker, and weekly coaching phone calls by a trained sleep coach. Assessments of sleep (actigraphy), glucose (A1C, continuous glucose monitoring), and patient-reported outcomes (questionnaires for daytime sleepiness, fatigue, diabetes distress, and depressive mood) were completed at baseline and at completion of the intervention. RESULTS: Sleep-Opt-In was feasible and acceptable. Those in Sleep-Opt-In with objectively confirmed short or irregular sleep demonstrated an improvement in sleep regularity (25 minutes), reduced glycemic variability (3.2%), and improved time in range (6.9%) compared to the Healthy Living attention control group. Patient-reported outcomes improved only for the Sleep-Opt-In group. Fatigue and depressive mood improved compared to the control. CONCLUSIONS: Sleep-Opt-In is feasible, acceptable, and promising for further evaluation as a means to improve sleep duration or regularity in the population of people with type 1 diabetes.

Sleep Technology Intervention to Target Cardiometabolic Health (STITCH): a randomized controlled study of a behavioral sleep extension intervention compared to an education control to improve sleep duration, blood pressure, and cardiometabolic health among adults with elevated blood pressure/hypertension.

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.

Neural responsiveness to reward and suicidal ideation in social anxiety and major depression before and after psychotherapy.

Suicidality is prevalent in Social Anxiety Disorder (SAD) and Major Depressive Disorder (MDD). Limited data indicate the reward positivity (RewP), a neurophysiological index of reward responsivity, and subjective capacity for pleasure may serve as brain and behavioral assays for suicide risk though this has yet to be examined in SAD or MDD in the context of psychotherapy. Therefore, the current study tested whether suicidal ideation (SI) relates to RewP and subjective capacity for anticipatory and consummatory pleasure at baseline and whether Cognitive Behavioral Therapy (CBT) impacts these measures. Participants with SAD (n = 55) or MDD (n = 54) completed a monetary reward task (gains vs. losses) during electroencephalogram (EEG) before being randomized to CBT or supportive therapy (ST), a comparator common factors arm. EEG and SI data were collected at baseline, mid-treatment, and post-treatment; capacity for pleasure was collected at baseline and post-treatment. Baseline results showed participants with SAD or MDD were comparable in SI, RewP, and capacity for pleasure. When controlling for symptom severity, SI negatively corresponded with RewP following gains and SI positively corresponded with RewP following losses at baseline. Yet, SI did not relate to subjective capacity for pleasure. Evidence of a distinct SI-RewP association suggests RewP may serve as a transdiagnositic brain-based marker of SI. Treatment outcome revealed that among participants with SI at baseline, SI significantly decreased regardless of treatment arm; also, consummatory, but not anticipatory, pleasure increased across participants regardless of treatment arm. RewP was stable following treatment, which has been reported in other clinical trial studies.

Association between sleep variability and time in range of glucose levels in patients with type 1 diabetes: Cross-sectional study.

OBJECTIVE: Sleep and circadian disturbances emerge as novel factors influencing glycemic control in type 1 diabetes (T1D). We aimed to explore the associations among sleep, behavioral circadian parameters, self-care, and glycemic parameters in T1D. METHODS: Seventy-six non-shift-working adult T1D patients participated. Blinded 7-day continuous glucose monitoring (CGM) and hemoglobin A1C (A1C) were collected. Percentages of time-in-range (glucose levels 70-180 mg/dL) and glycemic variability (measured by the coefficient of variation [%CV]) were calculated from CGM. Sleep (duration and efficiency) was recorded using 7-day actigraphy. Variability (standard deviation) of midsleep time was used to represent sleep variability. Nonparametric behavioral circadian variables were derived from actigraphy activity recordings. Self-care was measured by diabetes self-management questionnaire-revised. Multiple regression analyses were performed to identify independent predictors of glycemic parameters. RESULTS: Median (interquartile range) age was 34.0 (27.2, 43.1) years, 48 (63.2%) were female, and median (interquartile range) A1C was 6.8% (6.2, 7.4). Sleep duration, efficiency, and nonparametric behavioral circadian variables were not associated with glycemic parameters. After adjusting for age, sex, insulin delivery mode/CGM use, and ethnicity, each hour increase in sleep variability was associated with 9.64% less time-in-range (B = -9.64, 95% confidence interval [-16.29, -2.99], p ≤ .001). A higher diabetes self-management questionnaire score was an independent predictor of lower A1C (B = -0.18, 95% confidence interval [-0.32, -0.04]). CONCLUSION: Greater sleep timing variability is independently associated with less time spent in the desirable glucose range in this T1D cohort. Reducing sleep timing variability could potentially lead to improved metabolic control and should be explored in future research. DATA AVAILABILITY STATEMENT: Data are available upon a reasonable request to the corresponding author.

Smartphone-derived Virtual Keyboard Dynamics Coupled with Accelerometer Data as a Window into Understanding Brain Health: Smartphone Keyboard and Accelerometer as Window into Brain Health.

We examine the feasibility of using accelerometer data exclusively collected during typing on a custom smartphone keyboard to study whether typing dynamics are associated with daily variations in mood and cognition. As part of an ongoing digital mental health study involving mood disorders, we collected data from a well-characterized clinical sample (N = 85) and classified accelerometer data per typing session into orientation (upright vs. not) and motion (active vs. not). The mood disorder group showed lower cognitive performance despite mild symptoms (depression/mania). There were also diurnal pattern differences with respect to cognitive performance: individuals with higher cognitive performance typed faster and were less sensitive to time of day. They also exhibited more well-defined diurnal patterns in smartphone keyboard usage: they engaged with the keyboard more during the day and tapered their usage more at night compared to those with lower cognitive performance, suggesting a healthier usage of their phone.

Effectiveness and implementation of an electronic health record-integrated digital health intervention for managing depressive symptoms in ambulatory oncology: The My Well-Being Guide study rationale and protocol.

BACKGROUND: Rates of clinically elevated depressive symptoms among ambulatory oncology patients are higher than in the general population and are associated with poorer health-related quality of life. Furthermore, a reduction in depressive symptoms may be associated with improved cancer survival. Several interventions have demonstrated efficacy in reducing oncologic depressive symptoms, including cognitive-behavioral stress management (CBSM). However, more work is needed to understand how to best implement CBSM into practice, such as through stepped-care approaches and digital health interventions linked to electronic health records (EHR). This manuscript presents the protocol of the My Well-Being Guide study, a pragmatic type 1 effectiveness-implementation hybrid study. This trial will test the effectiveness of My Well-Being Guide, a seven-week structured, CBSM-based digital health intervention designed to reduce depressive symptoms. This trial will also evaluate My Well-Being Guide's implementation across two health systems. METHODS: The final sample (N = 4561) will be oncology patients at Northwestern Medicine or University of Miami Health System who are ≥18 years of age; have a cancer diagnosis; elevated depressive symptoms on the Patient-Reported Outcomes Measurement Information System Depression; and primary language is English or Spanish. Data collection will occur at baseline, and 2-, 6-, and 12-months post baseline. Outcome domains include depressive symptoms and implementation evaluation. DISCUSSION: This study may provide valuable data on the effectiveness of our depressive symptom management digital health intervention linked to the EHR and the scalability of digital health interventions in general.

Randomized controlled trial of Sunnyside: Individual versus group-based online interventions to prevent postpartum depression.

BACKGROUND: Postpartum depression (PPD) is a serious mental health problem that has a prevalence rate of nearly 20% in the first three months after delivery. The purpose of this study was to evaluate the benefit of Sunnyside, an internet-based cognitive-behavioral intervention, delivered in a group format compared to the same intervention delivered individually for the prevention of PPD. METHOD: 210 people between 20- and 28-weeks gestation and who scored between 5 and 14 on the PHQ-8 and who did not meet criteria for major depression were recruited online. The Inventory of Depression and Anxiety Symptoms (IDAS), the Hamilton Rating Scale for Depression (HAMD), and the depression and anxiety modules of the MINI were obtained at baseline, post-treatment, and 12-weeks postpartum. Intervention adherence was measured by site usage. RESULTS: Across self-report and interview measures of depression there were no significant differences in outcome between the group and the individual versions of the program. Rates of major depression and generalized anxiety disorder in the postpartum period were low and adherence to the conditions was similarly high. Participants in the individual condition were significantly more satisfied than participants in the group condition (p < 0.05). LIMITATIONS: The sample was predominantly white (85%) and recruited online, which may limit generalizability. CONCLUSIONS: The group intervention was not more effective than the individual intervention. However, ignoring groups, many measures improved over time. The results of this study provide evidence that mood symptoms improve when participating in an online preventive intervention for postpartum depression.