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BACKGROUND Sexual minority women (lesbian/gay, bisexual, pansexual, queer, and other non-heterosexual women) remain considerably underrepresented in health research despite being at a higher risk for diabetes and obesity as well as stigma, and psychological distress compared with heterosexual peers. Additionally, early life adversity (ELA) is prevalent among sexual minority women, which further increases risks for obesity, psychological distress, and poor cardiovascular health. App-based mindfulness interventions are potentially promising for sexual minority women both in mitigating the adverse health effects of ELA as well as reducing food craving and unhealthy eating, reducing risks associated with obesity. OBJECTIVE This mixed-methods feasibility trial aimed to test a mindfulness-based mobile health (mHealth) approach for middle-aged sexual minority women (age 30-55) with early life adversity and overweight/obesity (BMI ≥25) to improve health outcomes. METHODS The study was advertised on social media and various LGBTQ+ online groups. Interested individuals were invited to complete a brief screener and if eligible, they were contacted by a research assistant for an interview and study enrollment. At baseline, post-intervention (2-month), and 4-months follow-up, participants completed assessments of primary outcomes (food craving, emotional eating, and weight via a mailed scale) and secondary outcomes (depression, anxiety, mindfulness, and emotion dysregulation). A standardized weight measure was mailed to participants for weight reporting. Feasibility and acceptability were assessed at post-intervention via surveys and semi-structured exit-interviews. RESULTS We screened a total of 442 individuals, among which 30 eligible sexual minority women (Mean age = 40.20) from various regions of the U.S. enrolled in the study. At baseline, 86.7% and 80% of participants had elevated depressive and anxiety symptoms. Among enrolled participants, 20 (66.7%) completed all intervention modules, 25 (83.3%) were retained at the 2-month and 20 (66.7%) at 4-month follow-up. None reported adverse effects. From baseline to the 4-month follow-up, large effects were found in food craving (d = 1.64) and reward-based eating (d = 1.56) while small effects were found with weight (d = 0.20, 4.21kg on average). Significant improvements were also found in secondary outcomes (depression, d = 0.98; anxiety, d = 0.50; mindfulness, d = 0.49; emotion dysregulation, d = 0.44). Participants with higher parental verbal and emotional abuse were particularly responsive to the intervention. Participants reported the program aligned with their goals and expectations, was easy to use, and facilitated changes in eating behavior and mental health. Barriers for engagement included needs for diverse teachers, individualized support, and body positive language. CONCLUSIONS This early phase feasibility trial provides proof-of-concept support for a mindfulness mHealth approach to improve obesity-related outcomes among sexual minority women and warrants a larger randomized controlled trial in the future. Findings also suggest the need to attend to trauma and psychological health when addressing weight-related outcomes among sexual minority women. CLINICALTRIAL The study was preregistered as a clinical trial on Clinicaltrials.gov (trial identifier: NCT05201391).

Cardiovascular disease (CVD) is a persistent public health challenge and racial/ethnic minority populations experience disparities in CVD risk factors. Mindfulness-based Interventions (MBI) have been examined as a strategy to address CVD risk factors, though their potential for implementation with racial and ethnic minorities remains unclear. This review examines primary interventions studies testing the impact of MBI on CVD risk, with a focus on critical appraisal of implementation characteristics (i.e., intervention design, delivery, uptake, and contextual factors) relevant to the engagement of racial/ethnic minority populations. A systematic review identified 30 studies published through January 2022 for inclusion. Included studies were randomized controlled trials testing meditation or mindfulness-based interventions against any control to measure change or improvement in cardiovascular health measures or risk behaviors in adults living in the United States or territories. The Oxford Implementation Index was utilized to identify and extract relevant implementation data, and critical analysis of each study’s implementation process was conducted. All identified studies were published between 2011 and 2021 and represent early or pilot stages of research. As such, limitations and barriers in implementation strategies for racial/ethnic minority populations were identified. This review outlines several potential targets for future research to enhance engagement with racial/ethnic minorities.

Cue reactivity measured by functional magnetic resonance imaging is used in studies of substance-use disorders. This Consensus Statement is the result of a Delphi process to arrive at parameters that should be reported in describing these studies. Cue reactivity is one of the most frequently used paradigms in functional magnetic resonance imaging (fMRI) studies of substance use disorders (SUDs). Although there have been promising results elucidating the neurocognitive mechanisms of SUDs and SUD treatments, the interpretability and reproducibility of these studies is limited by incomplete reporting of participants characteristics, task design, craving assessment, scanning preparation and analysis decisions in fMRI drug cue reactivity (FDCR) experiments. This hampers clinical translation, not least because systematic review and meta-analysis of published work are difficult. This consensus paper and Delphi study aims to outline the important methodological aspects of FDCR research, present structured recommendations for more comprehensive methods reporting and review the FDCR literature to assess the reporting of items that are deemed important. Forty-five FDCR scientists from around the world participated in this study. First, an initial checklist of items deemed important in FDCR studies was developed by several members of the Enhanced NeuroImaging Genetics through Meta-Analyses (ENIGMA) Addiction working group on the basis of a systematic review. Using a modified Delphi consensus method, all experts were asked to comment on, revise or add items to the initial checklist, and then to rate the importance of each item in subsequent rounds. The reporting status of the items in the final checklist was investigated in 108 recently published FDCR studies identified through a systematic review. By the final round, 38 items reached the consensus threshold and were classified under seven major categories: Participants Characteristics, General fMRI Information, General Task Information, Cue Information, Craving Assessment Inside Scanner, Craving Assessment Outside Scanner and Pre- and Post-Scanning Considerations. The review of the 108 FDCR papers revealed significant gaps in the reporting of the items considered important by the experts. For instance, whereas items in the General fMRI Information category were reported in 90.5% of the reviewed papers, items in the Pre- and Post-Scanning Considerations category were reported by only 44.7% of reviewed FDCR studies. Considering the notable and sometimes unexpected gaps in the reporting of items deemed to be important by experts in any FDCR study, the protocols could benefit from the adoption of reporting standards. This checklist, a living document to be updated as the field and its methods advance, can help improve experimental design, reporting and the widespread understanding of the FDCR protocols. This checklist can also provide a sample for developing consensus statements for protocols in other areas of task-based fMRI. Funding Agencies|National Institute on Alcohol Abuse and Alcoholism (NIAAA)United States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH National Institute on Alcohol Abuse & Alcoholism (NIAAA) [P50 AA010761]; Deutsche Forschungsgemeinschaft (DFG, German Research Foundation)German Research Foundation (DFG) [402170461-TRR 265, 40217046-TRR 265, 421888313, 437718741, 324164820]; DFGGerman Research Foundation (DFG)European Commission [402170461 - TRR 265]; California Tobacco-Related Disease Research Grant Program of the University of California [T30IP0962]; Laureate Institute for Brain Research (LIBR); Warren K. Family Foundation; Oklahoma Center for Advancement of Science and Technologies (OCAST) [HR18-139]; Brain and Behavior Foundation (NARSAD Young Investigator Award) [27305]; National Institute on Drug Abuse (NIDA)United States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH National Institute on Drug Abuse (NIDA) [R01 DA030344, R21DA044465]; NIDAUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH National Institute on Drug Abuse (NIDA) [R01DA041528, R01DA048301, R01DA047851, K23DA042898, K12 DA000167, U01 DA041089, U24 DA041147, P30 DA048742]; NCCIH [R01AT010627]; NIAAAUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH National Institute on Alcohol Abuse & Alcoholism (NIAAA) [F32AA027699, R01 AA027765, R01 AA026859, U01 AA021692, U24 AA021695, R01AA023665, R01AA022328]; NIHUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USA [R01DA039135, K02DA042987, R01 DA041866, R01AA026844, K08AA023545, K23AA023894, R01DA040670, R21HL144673, R01DA041438, R21DA045853]; Bundesministerium fur Bildung und ForschungFederal Ministry of Education & Research (BMBF) [FKZ: 01ZX1503, 01ZX1909B]; Shanghai Municipal Science and Technology Major project [2019SHZDZX02]; Eli Lilly Canada Chair on schizophrenia researchEli Lilly; Australian Medical Research Future FundMedical Research Future Fund (MRFF) [MRF1141214]; National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81871426]

Background The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) is an important tool for assessing teacher skill and aspects of the fidelity of mindfulness-based interventions, but prior research on and implementation of the MBI:TAC has used video recordings, which can be difficult to obtain, share for assessments, and which increase privacy concerns for participants. Audio-only recordings might be a useful alternative, but their reliability is unknown. Objective To assess evaluator perception of the rating process and inter-rater reliability of MBI:TAC ratings using audio-only recordings. Methods We prepared audio-only files from video recordings of 21 previously rated Mindfulness-Based Stress Reduction teachers. Each audio recording was rated by 3 trained MBI:TAC assessors drawn from a pool of 12 who had previously participated in rating the video recordings. Teachers were rated by evaluators who had not viewed the video recording and did not know the teacher. We then conducted semi-structured interviews with evaluators. Results On the 6 MBI:TAC domains, the intraclass correlation coefficients (ICCs) for audio recordings ranged from .53 to .69 using an average across 3 evaluators. Using a single rating resulted in lower ICCs (.27-.38). Bland-Altman plots showed audio ratings had little consistent bias compared to video recordings and agreed more closely for teachers with higher ratings. Qualitative analysis identified 3 themes: video recordings were particularly helpful when rating less skillful teachers, video recordings tended to provide a more complete picture for rating, and audio rating had some positive features. Conclusions Inter-rater reliability of the MBI:TAC using audio-only recordings was adequate for many research and clinical purposes, and reliability is improved when using an average across several evaluators. Ratings using audio-only recordings may be more challenging when rating less experienced teachers.

Background App-based interventions provide a promising avenue for mitigating the burden on mental health services by complimenting therapist-led treatments for anxiety. However, it remains unclear how specific systems’ use of app features may be associated with changes in mental health outcomes (eg, anxiety and worry). Objective This study was a secondary analysis of engagement data from a stage 1 randomized controlled trial testing the impact of the Unwinding Anxiety mobile app among adults with generalized anxiety disorder. The aims of this study were 2-fold: to investigate whether higher microengagement with the primary intervention feature (ie, educational modules) is associated with positive changes in mental health outcomes at 2 months (ie, anxiety, worry, interoceptive awareness, and emotional reactivity) and to investigate whether the use of adjunctive app features is also associated with changes in mental health outcomes. Methods We analyzed the intervention group during the stage 1 trial of the Unwinding Anxiety mobile app. The total use of specific mobile app features and the use specific to each feature were calculated. We used multivariate linear models with a priori significance of α=.05 to investigate the impact of cumulative app use on anxiety, worry, interoceptive awareness, and emotional regulation at 2 months, controlling for baseline scores, age, and education level in all models. Significant relationships between system use metrics and baseline participant characteristics were assessed for differences in use groupings using between-group testing (ie, 2-tailed t tests for continuous data and chi-square analyses for categorical data). Results The sample was primarily female (25/27, 93%), and the average age was 42.9 (SD 15.6) years. Educational module completion, the central intervention component, averaged 20.2 (SD 11.4) modules out of 32 for the total sample. Multivariate models revealed that completing >75% of the program was associated with an average 22.6-point increase in interoceptive awareness (b=22.6; SE 8.32; P=.01; 95% CI 5.3-39.8) and an 11.6-point decrease in worry (b=−11.6; SE 4.12; P=.01; 95% CI −20.2 to −3.1). In addition, a single log unit change in the total number of meditations was associated with a 0.62-point reduction in the Generalized Anxiety Disorder-7 scale scores (b=0.62; SE 0.27; P=.005; 95% CI −1.2 to −0.6), whereas a single log unit use of the stress meter was associated with an average of a 0.5-point increase in emotional regulation scores (Five Facet Mindfulness Questionnaire; b=0.5; SE 0.21; P=.03; 95% CI 0.1-0.9). Conclusions This study offers a clearer understanding of the impact of engagement with app features on broader engagement with the health outcomes of interest. This study highlights the importance of comprehensive investigations of engagement during the development of evidence-based mobile apps.

BACKGROUND Mobile health applications provide a promising avenue to help mitigate the burden on mental health services by complimenting therapist-led treatments for anxiety. However, it remains unclear how specific systems' use of application components (i.e., tools) may be associated with changes in clinical symptomatology (i.e., anxiety, worry). OBJECTIVE This study was a secondary analysis of systems usage data from the Stage I randomized controlled trial testing the impact of the Unwinding Anxiety mobile application among adults with GAD. This secondary analysis was conducted to assess how using specific application tools may be associated with improvements in anxiety, worry, emotional regulation, and interoceptive awareness. METHODS We present analyses of the intervention group (i.e., those who received the Unwinding Anxiety program) during the Stage 1 trial. Total use of specific mobile application tools (i.e., ecological tools, meditation practices, educational modules) as well use specific to each tool (e.g., stress meter, lovingkindness meditation practice) were calculated. We utilized multivariate linear models to investigate the effect of total use of these tools on anxiety, worry, interoceptive awareness, emotional regulation at 2-months post-program initiation controlling for baseline scores, age, and education level. In addition, associations between systems usage metrics and baseline participant characteristics were assessed for differences in usage groupings. RESULTS The sample was primarily female (n=25; 92.6%) and the average age was 42.9 years old (SD=15.6) and educational module completion, the central intervention component, averaged 20.2 + 11.4 modules out of XXX for the total sample. Multivariate models revealed that completing >75% of the program was associated with an average 22.6-point increase in interoceptive awareness (SE=8.32, p=0.013) and an 11.6-point decrease in worry (SE=4.12, p=0.009). In addition, a single log unit change in total number of meditations was associated with a 0.95-point reduction in GAD-7 scores (SE=0.27, p=0.005) while a single log unit use of the stress meter was associated with an average of a 0.5-point increase in emotional regulation scores (FFMQ) (SE=0.21, p=0.027). CONCLUSIONS The work presented offers a clearer understanding of the impact of specific mobile app systems use on mental health outcomes. In addition, this research lays the groundwork for future comprehensive investigations of systems usage in dosing studies for health behavior change. CLINICALTRIAL Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder (NCT03683472).

In the modern world, it is hard to imagine a day without some form of interaction with digital data. Real world data originating from signal generating transducers or communication channels are often recorded as streams of data samples separated by time stamps, sample counters or simply data record delimiter e.g. newline (\n), comma (,) etc. Sampling is the basis of statistical estimation from any data source containing signal records. The process of random sampling has been in practice since time immemorial. However, rapid scale of data generation processes working in tandem with of computing infrastructures , the volume of data is getting quite unmanageably large in nearly every discipline of science. On the other hand, mere volume of data is of no consequence if we can’t extract effective intelligence out of it on an “on demand” basis. Of particular interest is the case where data is stored in a file as a record separated by newline(or any other delimiter) character. When the number of records in the file is greater than a threshold, random sampling is a formidable task. It is nearly impossible to pragmatically load the entire file in the computer memory or even if theoretically possible, the time it takes to load the data in its entirety from natural data sources can be overwhelmingly long or often unnecessary! We can strategically bypass these problems by carefully designing a data interface tool such that any part of a given file can be instantly accessed for random sampling or other kinds of processing tasks by loading only the necessary parts of the data. With this goal, we created a novel, portable and highly efficient rapid data access tool named GSFRS: Giant Signal File Random Sampler, written in modern C++ language to enable near real-time access to any part of an arbitrarily large sized data file that is almost independent of the file size for all practical scenarios. Also, big-data processing would become relatively commonplace and cost effective even in commodity hardwares once the indices are made available through its indexing protocol. This capability would potentially revolutionize the way we gather intelligence from files containing large samples. Adaptation of GSFRS at the source level of various data generators, processing times and energy footprints of various computations can be dramatically reduced.

BACKGROUND Half of people living with HIV (PLWH) are cigarette smokers. Stress and craving to smoke are two major predictors of smoking relapse in PLWH. Mindfulness is effective in reducing stress and controlling craving to smoke. Contingency Management (CM) improves cessation in hard-to-treat smokers. Smartphone applications (app) improve access to treatment. OBJECTIVE Guided by the Spiral Technology Action Research Model (Listen, Plan, Do, Act, Study), we sought to adapt an existing evidence-based mindfulness smoking cessation app “Craving to Quit” to PLWH. Appling user-centered participatory mixed methods of qualitative and quantitative design, this study involves “Listen” to PLWH smokers to adapt the content of the app, and “Plan” for the creation of the new app. METHODS We conducted 8 focus groups combined with a brief survey among PLWH smokers (n=59; 47.5% females; >18 years) receiving treatment at an academic clinic. Participants completed a brief survey, then were instructed to download the “Craving to Quit” app and received a demonstration explaining the app content. Focus group discussion explored previous quit attempts, thoughts concerning the app, and perception about adding CM and strategies to track adherence to HIV treatment in the app. Participants were also asked to practice 3 mindfulness exercises and watch 3 videos from the app presented on a big screen in the conference room to discuss their experience, reaction, and concerns. Sessions were audio-taped, transcribed verbatim, and analyzed thematically using NVivo. RESULTS Participants were mostly non-Hispanic black (67.8%), heterosexual (79.7%), on Medicaid (61.0%), heavy alcohol users (30.5%), and depressed (44.1%). In focus group discussion, participants reported multiple drug use (alcohol, marijuana) and being surrounded by smokers as tremendous challenges to quitting, and that nicotine replacement treatment was not helpful. Participants considered mindfulness (RAIN, body scan, loving kindness) helpful in reducing stress, and videos (habit loop, costs benefits, tripping on thoughts) as effective in motivating quit attempts. Participants felt it is necessary to make the app available for free, add information about smoking medications and the effects of smoking on HIV treatment. Participants were supportive of adding CM and considered receiving $20-$50 weekly cash incentives helpful in supporting quit attempts. Participants thought that adding strategies to track adherence to ART helpful, but a few were concerned about confidentiality in case they lost their phone. CONCLUSIONS Findings from this formative qualitative research underscore the need for comprehensive approaches to smoking cessation in PLWH that integrate mindfulness, short-term CM, and strategies to improve adherence to HIV treatment. Further clinical research is needed to test the feasibility and acceptability of comprehensive interventions to address smoking as a key driver of morbidity and mortality in PLWH. CLINICALTRIAL N/A