Development of a Multicomponent Mindfulness and Movement Program for Lumbosacral Radicular Pain: A Mixed Methods Protocol

Mobile device-enabled interventions known as digital therapeutics (DTx) are increasingly used to prevent chronic disease by targeting psychological and behavioral processes. Individuals' unique experiences while receiving DTx comprise real-world evidence (RWE) for evaluating DTx performance. An emerging strategy for early-stage DTx formative work uses small sample sizes, which facilitate efficient iteration and agile learning, while evaluating performance against descriptive benchmarks defined a priori, therefore minimizing the risk for confirmation bias. This study test benchmarks from the DTx RWE framework to formatively evaluate a novel DTx (the eMOTION study) to enhance affective response (ie, how people feel) during physical activity (PA). This study aimed to determine whether the eMOTION DTx met a priori benchmarks for safety (<1% of participants report an adverse event), plausibility (≥51% of participants experience increased enjoyment in PA), usability (eg, ≥51% of participants report adequate usability), sustainability, feasibility (eg, <70% of participants report dissatisfaction), and equity (equity and accessibility are approximately equal across subgroups). Participants (N=36; mean age 46, SD 14 years; 20/37, 54% female) underwent stratified random assignment to test one of four DTx versions for 14 days (n=9 each): (1) intensity PA goals, (2) affect PA goals with type and context recommendations, (3) affect PA goals with savoring exercises, and (4) affect PA goals with type, context, and savoring. Participants completed daily intervention sessions, asking them to focus on achieving a target heart rate (intensity) or feeling good (affect) during PA. Smartwatches were used to track PA and answer ecological momentary assessment (EMA) questions about how they felt during PA. Performance toward benchmarks was primarily assessed via official Institutional Review Board reporting channels (safety), interviews (plausibility, accessibility, and usability), and questionnaires (System Usability Scale [usability], Delighted-Terrible Scale [sustainability and feasibility], and equity). The eMOTION DTx versions exceeded all a priori safety, plausibility, accessibility, usability, sustainability, feasibility, and equity thresholds. For safety, no adverse events were reported. Regarding plausibility, more than half of the participants who received affect goals reported increased PA enjoyment at the end of the study. Moreover, 64%-72% (23-26 out of 36) of participants rated the DTx at or above the standard System Usability Scale cutoff point for acceptable usability. More than 60% (22/36) of participants reported satisfaction with all DTx components, supporting DTx sustainability and feasibility. Finally, there was evidence for equity, with plausibility and accessibility comparable across sex, race, ethnicity, income, age, BMI, mobility, and physical constraint subgroups. Since DTx RWE Framework benchmarks for safety, plausibility, accessibility, usability, sustainability, feasibility, and equity were largely met, the eMOTION Study DTx is ready for a full-scale efficacy trial to refine the DTx and optimize efficiency and feasibility. Our approach incorporated transparent decision-making to generate results that are more readily translatable, easily replicable, and reflect current best practices in the field of DTx. ClinicalTrials.gov NCT06125964; https://clinicaltrials.gov/study/NCT06125964.

Ecological momentary assessment for assessing depression in advanced dementia: a pilot study

Social media use is common in adolescents, with implications for psychosocial development and the emergence of depression. Yet, little is known about the time-linked connections between social media use and adolescents' affective experiences and how they may differ between depressed and non-depressed youth. We leveraged ecological momentary assessment in adolescents oversampled for current depression to examine (1) associations between social media use and concurrent and later positive and negative affect and (2) sex and presence of a depressive disorder as moderators of these associations. Adolescents aged 14-17 with (n = 48) and without (n = 97) clinical depression, as indicated via clinical interview, reported momentary social media use and positive and negative affect seven times per day for one week. Multilevel modeling indicated that social media use was associated with reduced positive affect both concurrently and at the next assessment. Further, among clinically depressed youth only, social media use was associated with reduced negative affect at the next assessment. Results suggest that social media use may reduce both positive and negative affect, highlighting the nuanced relation between adolescent social media use and emotional health and laying the groundwork for future research to address several open questions.

Technology for behavioral assessment and intervention in bariatric surgery

Introduction:Increased cancer survivorship has prompted focus on optimising quality of life, including work reintegration. Despite frequently cited return-to-work barriers for women with breast cancer, there are no conclusive work-focused interventions for this cohort. The aim of this study was to assess feasibility and acceptability of a self-management intervention supporting return-to-work for women with breast cancer.Methods:A mixed-methods single-arm feasibility study evaluated intervention feasibility. Participants completed an online occupational therapy-led ‘Work and Cancer’ intervention over 6 weeks. Feasibility was determined by recruitment, adherence, retention and acceptability. Acceptability was also assessed through semi-structured interviews. Data were analysed using descriptive statistics and thematic analysis.Results:Ten out of twelve participants who were approached, participated in the study. Retention and adherence was 100% and 90%, respectively. Every participant completed pre- and post-measures. Qualitative data indicated online and group format as enablers to intervention completion and juggling employment as a barrier.Conclusion:It is feasible to recruit and retain participants to the ‘Work and Cancer’ intervention which was widely accepted by women with breast cancer. Large-scale evaluation will determine intervention effectiveness on work and health-related outcomes.

BackgroundAs existing treatments for negative symptoms in schizophrenia have limited empirical support, development of effective treatments for negative symptoms in schizophrenia is in urgent need. Behavioral activation (BA), which is an evidence-based treatment for depression, is a promising candidate treatment for negative symptoms as it proved its feasibility and preliminary efficacy in non-randomized controlled trial for community dwelling individuals with chronic schizophrenia (Choi et al., 2015; Mairs et al., 2011). The primary purpose of the current study was to investigate whether BA would improve negative symptoms as compared with treatment as usual (TAU) for community dwelling individuals with chronic schizophrenia in a multi-site randomized controlled trial. In addition, we explored whether BA would improve other psychiatric symptoms, quality of life and neuro-cognitive functioning.MethodsFor multi-site trials, mental health professionals were trained with BA manual (Choi et al., 2015) and their fidelity was checked by the authors. BA was delivered in a group format once a week for 10 weeks. Participants aged 18 years or older were recruited from community mental health centers and day hospitals in Seoul and Gyeonggi-do area. A total of seventy-two patients with negative symptoms of schizophrenia were randomly assigned into either BA+TAU or TAU. As a primary outcome, negative symptoms were measured using clinical interviews (e.g., BNSS, CAINS, PANSS negative symptoms factor) and self-report questionnaires (i.e., MAP-SR) before and after the 10-week treatments. The secondary outcome measures included other psychiatric symptoms, quality of life, and neuro-cognitive assessment.ResultsBA was well accepted by community dwelling individuals with chronic schizophrenia (drop-out rates of BA+TAU and TAU, 10% and 14%, respectively). Intention-to-treat analyses indicated that compared to TAU condition, BA+TAU group showed greater improvement in negative symptoms, as measured by CAINS, BNSS, and PANSS negative symptom factor (Time*Group interaction effects, F=7.476, p<.01 for CAINS total; F=5.663, p<.05 for BNSS total; F=6.092, p<.05 for PANSS negative symptoms factor). In addition, the results indicated group differences in favor of BA+TAU on the PANSS general psychopathology factor and the Quality of Life, but not neurocognitive functioning (Time*Group interaction effects, F=5.660, p<.05 for PANSS general psychopathology factor; F=7.541, p<.01 for QOL total).DiscussionThe results of the current study demonstrate the feasibility and the efficacy of BA+TAU for negative symptoms of community dwelling individuals with chronic schizophrenia as compared to TAU when delivered by BA trained mental health professionals. Thus, it is speculated that BA is an effective adjunct psychosocial approach to usual comprehensive psychiatric rehabilitation for negative symptoms. Since the current study is ongoing and follow-up data will be available by the time of presentation at SIRS 2018, it will be examined whether benefits of BA would be maintained 3 months after the termination of 10-week BA treatment.

As a member of the Back Pain Consortium (BACPAC), the University of Pittsburgh Mechanistic Research Center's research goal is to phenotype chronic low back pain using biological, biomechanical, and behavioral domains using a prospective, observational cohort study. Data will be collected from 1,000 participants with chronic low back pain according to BACPAC-wide harmonized and study-specific protocols. Participation lasts 12 months with one required in person baseline visit, an optional second in person visit for advanced biomechanical assessment, and electronic follow ups at months 1, 2, 3, 4, 5, 6, 9, and 12 to assess low back pain status and response to prescribed treatments. Behavioral data analysis includes a battery of patient-reported outcomes, social determinants of health, quantitative sensory testing, and physical activity. Biological data analysis includes omics generated from blood, saliva, and spine tissue. Biomechanical data analysis includes a physical examination, lumbopelvic kinematics, and intervertebral kinematics. The statistical analysis includes traditional unsupervised machine learning approaches to categorize participants into groups and determine the variables that differentiate patients. Additional analysis includes the creation of a series of decision rules based on baseline measures and treatment pathways as inputs to predict clinical outcomes. The characteristics identified will contribute to future studies to assist clinicians in designing a personalized, optimal treatment approach for each patient.

Background: Intimate partner relationships significantly influence suicidal thoughts and behaviors (STB), yet research examining these complex dynamics has been fragmented. This study investigated the pathways through which relationship factors influence suicidality by analyzing 120 cases with diverse relationship experiences and suicidal histories. Methods: Using a mixed-methods approach, we collected data through structured clinical interviews, standardized relationship assessments, in-depth qualitative interviews, timeline follow-back calendars, and ecological momentary assessment. Quantitative analyses included multivariate regression and path analysis models, while qualitative data underwent constructivist grounded theory analysis, followed by an integrated case typology development. Results: Four distinct relationship-suicide pathways emerged: crisis-triggered (30.8%), characterized by acute relationship ruptures; chronic deterioration (35.8%), marked by ongoing conflict and communication breakdown; abusive control (23.3%), involving power imbalance and entrapment; and attachment vulnerability (10.0%), defined by intense fears of abandonment. Timeline data revealed rapid progression (0-3 days) from certain relationship events to suicidal crises. Significant mediating mechanisms included thwarted belongingness, perceived burdensomeness, emotional dysregulation, and entrapment. Qualitative analysis identified five themes: relationship as identity, entrapment and hopelessness, relationship as safe haven, relational self-blame, and cyclical crisis patterns. Conclusions: This study advances understanding of intimate partner relationship influences on suicidality by identifying distinct relationship-suicide pathways, temporal dynamics, and psychological mechanisms. Findings suggest the need for differentiated clinical approaches based on relationship patterns and targeted interventions addressing specific mediating mechanisms. Integrating relationship counseling wit

Persistent idiopathic facial pain exists independent of somatosensory input from the painful region: findings from quantitative sensory functions and somatotopy of the primary somatosensory cortex

BackgroundPoor sleep, defined as short-duration or poor-quality sleep, is a frequently reported condition with many deleterious effects including poorer cognitive functioning, increased accidents, and poorer health. Melatonin has been shown to be an efficacious treatment to manage symptoms of poor sleep. However, the treatment effects of melatonin on sleep can vary greatly between participants. Personalized, or N-of-1, trial designs represent a method for identifying the best treatment for individual participants. Although using N-of-1 trials of melatonin to treat poor sleep is possible, the feasibility, acceptability, and effectiveness of N-of-1 trials using melatonin are unknown. Using the National Institutes of Health Stage Model for Behavioral Intervention Development, a stage IB (intervention refinement, modification, and adaptation and pilot testing) design appeared to be needed to address these feasibility questions.ObjectiveThis trial series evaluates the feasibility, acceptability, and effectiveness of a series of personalized interventions for remote delivery of melatonin dose (3 and 0.5 mg) versus placebo supplements for self-reported poor sleep among 60 participants. The goal of this study is to provide valuable information about implementing remote N-of-1 randomized controlled trials to improve poor sleep.MethodsParticipants will complete a 2-week baseline followed by six 2-week alternating intervention periods of 3 mg of melatonin, 0.5 mg of melatonin, and placebo. Participants will be randomly assigned to 2 intervention orders. The feasibility and acceptability of the personalized trial approach will be determined with participants’ ratings of usability and satisfaction with the remote, personalized intervention delivery system. The effectiveness of the intervention will be measured using participants’ self-reported sleep quality and duration and Fitbit tracker–measured sleep duration and efficiency. Additional measures will include ecological momentary assessment measures of fatigue, stress, pain, mood, concentration, and confidence as well as measures of participant adherence to the intervention, use of the Fitbit tracker, and survey data collection.ResultsAs of the submission of this protocol, recruitment for this National Institutes of Health stage IB personalized trial series is approximately 78.3% complete (47/60). We expect recruitment and data collection to be finalized by June 2023.ConclusionsEvaluating the feasibility, acceptability, and effectiveness of a series of personalized interventions of melatonin will address the longer term aim of this program of research—is integrating N-of-1 trials useful patient care? The personalized trial series results will be published in a peer-reviewed journal and will follow the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015) reporting guidelines. This trial series was approved by the Northwell Health institutional review board.Trial RegistrationClinicalTrials.gov NCT05349188; https://www.clinicaltrials.gov/study/NCT05349188International Registered Report Identifier (IRRID)DERR1-10.2196/45313

The article examines the problem of the contradiction between the mass format of group functional training sessions and the need to individualize workloads taking into account the health condition of the participants. The relevance of the study is due to the increase in injuries and the decrease in training effectiveness when using standardized programs for the heterogeneous clientele of fitness clubs. The purpose of the study is the development and justification of the structure of a comprehensive diagnostic system that ensures safety and personalization in group settings. Research methods: theoretical analysis and generalization of scientific and methodological literature; pedagogical observation of the training process in group programs; methods of functional diagnostics (movement screening, anthropometry); a systematic approach to organizing training activities. Research results. The developed system includes three interconnected components: medical-biological diagnostics, assessment of movement biomechanics, and monitoring of subjective condition. The implementation of this system allows instructors to differentiate the load through the variability of exercises (regressions/progressions) and intensity control. It is substantiated that the use of comprehensive diagnostics minimizes the risks of exacerbating chronic pathologies, ensures compliance with the principle of individualization, and increases engagement in the training process without losing the benefits of the group format.

Treated hypothyroidism is associated with cerebrovascular disease but not Alzheimer's disease pathology in older adults

Improving our understanding of the relationship between maternal depression and parenting stress is likely to lie in the range of additional factors that are associated with vulnerability to depression and also to parenting stress. To examine the role of trauma and partner support, in understanding the relationship between perinatal depression and parenting stress. This study utilises data from 246 women in a pregnancy cohort study that followed women from early pregnancy until their infant was 12 months. Included were both women with a diagnosis of depression and those without depression. The measures included Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Edinburgh Postnatal Depression Scale, Childhood Trauma Questionnaire, Social Support Effectiveness Questionnaire and the Parenting Stress Index. We found women with depression were more likely to report a history of childhood trauma. Depressive symptoms were positively associated with parenting stress while partner support was negatively associated with parenting stress. The protective role of partner support for parenting distress was observed in those with no history of childhood abuse and low depressive symptoms, but not in those with a trauma history and high depressive symptoms. These findings highlight the importance of early trauma in understanding the protective role of support on the relationship between parenting and depression. These findings can inform future studies and the refinement of future interventions aimed at both perinatal depression and parenting.

BackgroundFamily caregiving for individuals with Alzheimer disease and related dementias (ADRD) is characterized by increasing complexity, intensity, and demand across the disease trajectory. Formal home- and community-based services can provide knowledge, skills, and resources to enhance preparedness and self-efficacy, which may protect against adverse caregiving outcomes; however, awareness and uptake of these services remain low. As caregivers increasingly turn to the internet for information and support in their role, technology offers an opportunity to create a more seamless pipeline between assessment and service referral to match family caregivers with targeted services that meet their specific needs.ObjectiveThe primary objective of this study is to evaluate the feasibility and acceptability of CarePair—a mobile self-assessment and service referral platform—among ADRD family caregivers. Secondary objectives are to assess the preliminary efficacy of CarePair in reducing stress, depressive symptoms, and anxiety, and enhancing self-efficacy among caregivers randomized to the intervention versus an attention control condition. This study also aims to generate preliminary effect size estimates to inform sample size calculations for a future fully powered randomized controlled trial (RCT).MethodsThis pilot RCT will evaluate the feasibility, acceptability, and preliminary efficacy of CarePair. Eighty ADRD family caregivers will be enrolled and randomized in a 1:1 ratio to the intervention (n=40) or an attention control condition (n=40). Recruitment will be facilitated by the project study site located in an urban metropolitan area of the United States, targeting participants who report residing in and/or being in close proximity to any of the following locations: New York City, Long Island, and Westchester County, New York; Seattle, Washington; and Los Angeles, California. Primary feasibility outcomes include recruitment, retention, and completion rates; website usability; and intervention satisfaction. Exploratory analyses will assess preliminary efficacy on stress, depressive and anxiety symptoms, and self-efficacy.ResultsThis trial was funded by the National Institute on Aging in September 2023 and received approval from the institutional review board of the University of Southern California on September 10, 2025. Recruitment began in September 2025 and is scheduled to conclude in May 2026, with data collection scheduled to end in August 2026. As of February 2026, 44 participants have been enrolled and 22 have completed the study.ConclusionsThis pilot trial will offer foundational evidence regarding the feasibility and acceptability of the CarePair intervention. Study findings will determine if “go” criteria are met to warrant the advancement to a larger-scale efficacy trial. Participant insights will also be used to guide intervention refinements and digital platform optimization. By offering a low-burden, caregiver-centered mobile app, CarePair has the potential to facilitate and streamline the timely identification of needs and referral to relevant services for ADRD family caregivers.

Young people at clinical high risk for psychosis (CHR-p) commonly experience social impairment, which contributes to functional decline and predicts transition to psychotic illness. Although the use of smart phone technology and social media platforms for social interaction is widespread among today's youth, it is unclear whether aberrant digital social interactions contribute to risk for conversion and functional impairment in CHR-p. The current study sought to characterize the nature of social smartphone and social media use in a CHR-p sample and determine its association with clinical symptoms and risk for conversion to psychosis. CHR-p (n = 132) and HC (n = 61) participants completed clinical interviews and 6 days of digital phenotyping that monitored total smartphone use, ratio of outgoing to incoming text messages and phone calls, social media use, and ecological momentary assessment surveys focused on in-person and electronic social interactions. Study Results: CHR-p did not differ from HC in total smartphone use for social communication or active social media use. However, CHR-p participants reported significantly less daily passive social media use compared to HC peers, and decreased text message reciprocity predicted 1- and 2-year conversion risk. Results demonstrate a nuanced digital social landscape with divergent relationships from in-person social behavior and suggest online socialization has implications for high-precision identification and intervention strategies among the CHR-p population.