Smartband-based smoking detection and real-time brief mindfulness intervention: findings from a feasibility clinical trial.

BACKGROUND: Smartbands can be used to detect cigarette smoking and deliver real time smoking interventions. Brief mindfulness interventions have been found to reduce smoking. OBJECTIVE: This single arm feasibility trial used a smartband to detect smoking and deliver brief mindfulness exercises. METHODS: Daily smokers who were motivated to reduce their smoking wore a smartband for 60 days. For 21 days, the smartband monitored, detected and notified the user of smoking in real time. After 21 days, a 'mindful smoking' exercise was triggered by detected smoking. After 28 days, a 'RAIN' (recognize, allow, investigate, nonidentify) exercise was delivered to predicted smoking. Participants received mindfulness exercises by text message and online mindfulness training. Feasibility measures included treatment fidelity, adherence and acceptability. RESULTS: Participants (N=155) were 54% female, 76% white non-Hispanic, and treatment starters (n=115) were analyzed. Treatment fidelity cutoffs were met, including for detecting smoking and delivering mindfulness exercises. Adherence was mixed, including moderate smartband use and low completion of mindfulness exercises. Acceptability was mixed, including high helpfulness ratings and mixed user experiences data. Retention of treatment starters was high (81.9%). CONCLUSIONS: Findings demonstrate the feasibility of using a smartband to track smoking and deliver quit smoking interventions contingent on smoking.

A systematic review and meta-analysis of psychosocial interventions for persons with comorbid anxiety and substance use disorders.

BACKGROUND & AIMS: Anxiety and substance use disorders are highly comorbid and represent two of the leading causes of disease burden globally. Psychosocial interventions are important treatment options for people with co-occurring anxiety and substance use disorders (A-SUD). To date, few reviews have assessed the efficacy of psychosocial treatments for patients with A-SUD. This systematic review and meta-analysis aims to synthesize this literature and assess the efficacy of psychosocial interventions among patients with A-SUD. METHODS: We searched all relevant records published until March 2023 in Medline, EMBASE, PsycINFO, CINAHL and Google Scholar. Two authors extracted and reconciled relevant data and assessed risk of bias. Random effects models were used to calculate effect sizes using Hedges' g for post treatment and follow-up time points. Main outcomes of the review were anxiety, alcohol use, and use of other substances. We examined effects on depression as a secondary outcome since it commonly co-occurs with A-SUD. RESULTS: Psychosocial interventions for co-occurring A-SUD showed moderate effects on anxiety (g = 0.44), alcohol (Hedges' g = 0.29), and other substance use (g = 0.38) at post intervention. Large effects were observed on depression (g = 0.88) at post intervention with high heterogeneity. These effects were maintained at follow-up for anxiety (Hedges' g = 0.38), other substances (g = 0.44), and depression (g = 0.50). Moderation analyses for demographic factors, intervention characteristics, community level factors, anxiety reduction, and alcohol use reduction, were non-significant. CONCLUSIONS: The current meta-analysis is the first to investigate specifically the effects of psychosocial interventions on patients with anxiety and a co-occurring SUD. The analyses indicated promising moderate-sized effects of treatment on anxiety, alcohol, all other drug use, and depression. The findings point to important avenues for psychosocial treatment emphasis and development while highlighting critical gaps in knowledge to be addressed in future research.

Parameter Space and Potential for Biomarker Development in 25 Years of fMRI Drug Cue Reactivity: A Systematic Review.

Importance: In the last 25 years, functional magnetic resonance imaging drug cue reactivity (FDCR) studies have characterized some core aspects in the neurobiology of drug addiction. However, no FDCR-derived biomarkers have been approved for treatment development or clinical adoption. Traversing this translational gap requires a systematic assessment of the FDCR literature evidence, its heterogeneity, and an evaluation of possible clinical uses of FDCR-derived biomarkers. Objective: To summarize the state of the field of FDCR, assess their potential for biomarker development, and outline a clear process for biomarker qualification to guide future research and validation efforts. Evidence Review: The PubMed and Medline databases were searched for every original FDCR investigation published from database inception until December 2022. Collected data covered study design, participant characteristics, FDCR task design, and whether each study provided evidence that might potentially help develop susceptibility, diagnostic, response, prognostic, predictive, or severity biomarkers for 1 or more addictive disorders. Findings: There were 415 FDCR studies published between 1998 and 2022. Most focused on nicotine (122 [29.6%]), alcohol (120 [29.2%]), or cocaine (46 [11.1%]), and most used visual cues (354 [85.3%]). Together, these studies recruited 19 311 participants, including 13 812 individuals with past or current substance use disorders. Most studies could potentially support biomarker development, including diagnostic (143 [32.7%]), treatment response (141 [32.3%]), severity (84 [19.2%]), prognostic (30 [6.9%]), predictive (25 [5.7%]), monitoring (12 [2.7%]), and susceptibility (2 [0.5%]) biomarkers. A total of 155 interventional studies used FDCR, mostly to investigate pharmacological (67 [43.2%]) or cognitive/behavioral (51 [32.9%]) interventions; 141 studies used FDCR as a response measure, of which 125 (88.7%) reported significant interventional FDCR alterations; and 25 studies used FDCR as an intervention outcome predictor, with 24 (96%) finding significant associations between FDCR markers and treatment outcomes. Conclusions and Relevance: Based on this systematic review and the proposed biomarker development framework, there is a pathway for the development and regulatory qualification of FDCR-based biomarkers of addiction and recovery. Further validation could support the use of FDCR-derived measures, potentially accelerating treatment development and improving diagnostic, prognostic, and predictive clinical judgments.

Mindfulness-Based Mobile Health to Address Unhealthy Eating Among Middle-Aged Sexual Minority Women With Early Life Adversity: Mixed Methods Feasibility Trial.

BACKGROUND: Sexual minority women (lesbian, gay, bisexual, pansexual, queer, and other nonheterosexual women) remain considerably underrepresented in health research despite being at a higher risk for diabetes and obesity as well as stigma and psychological distress than their heterosexual peers. In addition, 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 this group in mitigating the adverse health effects of ELA, reducing food craving and unhealthy eating, addressing the risks associated with obesity. OBJECTIVE: This mixed methods feasibility trial aimed to test a mindfulness-based mobile health approach for middle-aged sexual minority women (aged 30-55 years) with ELA and overweight or obesity (BMI ≥25 kg/m2) to improve health outcomes. METHODS: The single-arm trial was advertised on social media and various lesbian, gay, bisexual, transgender, and queer web-based groups. At baseline, after the intervention (2 months), and at the 4-month 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 after the intervention via surveys and semistructured exit interviews. RESULTS: We screened 442 individuals, among which 30 eligible sexual minority women (mean age 40.20, SD 7.15 years) from various US regions were enrolled in the study. At baseline, 86% (26/30) and 80% (24/30) of participants had elevated depressive and anxiety symptoms, respectively. Among the 30 enrolled participants, 20 (66%) completed all intervention modules, 25 (83%) were retained at the 2-month follow-up, and 20 (66%) were retained at the 4-month follow-up. None reported adverse effects. From baseline to the 4-month follow-up, large effects were found in food craving (Cohen d=1.64) and reward-based eating (Cohen d=1.56), whereas small effects were found with weight (Cohen d=0.20; 4.21 kg on average). Significant improvements were also found in the secondary outcomes (depression, Cohen d=0.98; anxiety, Cohen d=0.50; mindfulness, Cohen d=0.49; and emotion dysregulation, Cohen d=0.44; all P<.05). Participants with higher levels of parental verbal and emotional abuse were particularly responsive to the intervention. Participants reported that the program aligned with their goals and expectations, was easy to use, and facilitated changes in eating behavior and mental health. Barriers to engagement included the need for diverse teachers, individualized support, and body positive language. CONCLUSIONS: This early phase feasibility trial provides proof-of-concept support for a mindfulness mobile health approach to improve obesity-related outcomes among sexual minority women and warrants a larger randomized controlled trial in the future. The findings also suggest the need to address trauma and psychological health when addressing weight-related outcomes among sexual minority women.

The Reliability of Rating via Audio-Recording Using the Mindfulness-Based Interventions: Teaching Assessment Criteria.

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.

App-Delivered Mindfulness Training to Reduce Anxiety in People with HIV Who Smoke: A One-Armed Feasibility Trial.

INTRODUCTION: People with HIV (PWH) who smoke have reported that managing anxiety is a barrier to making a quit attempt and maintaining abstinence post-quit. This study examined the feasibility and acceptability of an app-based mindfulness intervention, Unwinding Anxiety, to reduce anxiety prior to a quit attempt in PWH who were not planning to quit in the next 30 days. METHODS: Sixteen PWH (mean age 51.5 [SD = 13.2]; mean cigarettes per day 11.4 [SD = 5.4]) were enrolled and followed for eight weeks. A smartphone-based app with 30 modules designed to reduce anxiety was introduced at baseline; participants were encouraged to complete one module daily for four weeks. Symptoms of anxiety and readiness to quit smoking were measured at baseline and weeks 4 and 8. The mean number of modules completed, session attendance, and number of study completers were examined. Generalized estimating equations (GEE) were used to examine changes in self-reported anxiety and readiness to quit at baseline, week 4, and week 8. A brief qualitative interview was conducted at week 4 to explore the acceptability of the app. RESULTS: Feasibility was high, with 93% of participants completing the study. The mean number of study sessions completed was 2.7 (SD = 0.59), and the mean number of modules completed was 16.0 (SD 16.8). Anxiety was high at baseline (M = 14.4, SD = 3.9), but lower at week 4 (b = -5.5; CI: [-9.4, -1.7]; p = 0.004) and week 8 (b = -5.1; CI: [-8.8, -1.3]; p = 0.008), and stable between weeks 4 and 8 (b = 0.48; CI: [-2.0, 3.0]; p = 0.706). Readiness to quit significantly increased from baseline M = 5.5 (SD = 1.6) to week 4 (b = 0.56; CI: [0.20, 0.91]; p = 0.002) but was not significantly different from baseline at week 8 (b = 0.34; CI: [-0.30, 1.0]; p = 0.30). Ad-hoc moderation analyses found that anxiety had a small significantly positive association with readiness to quit at baseline (main effect: b = 0.10; SE = 0.03; p < 0.001) and significantly attenuated the increase in readiness to quit observed at week 4 (anxiety by week 4 interaction: b = -0.08; SE = 0.03; p = 0.009). CONCLUSIONS: App-based mindfulness training appears to be feasible and acceptable for PWH who smoke and report baseline anxiety. At week 4, anxiety was reduced and readiness to quit was increased, perhaps a key time point for a smoking cessation attempt.

Cluster-based psychological phenotyping and differences in anxiety treatment outcomes.

The identification of markers of mental health illness treatment response and susceptibility using personalized medicine has been elusive. In the context of psychological treatment for anxiety, we conducted two studies to identify psychological phenotypes with distinct characteristics related to: psychological intervention modalities (mindfulness training/awareness), mechanism of action (worry), and clinical outcome (generalized anxiety disorder scale scores). We also examined whether phenotype membership interacted with treatment response (Study 1) and mental health illness diagnosis (Studies 1-2). Interoceptive awareness, emotional reactivity, worry, and anxiety were assessed at baseline in treatment-seeking individuals (Study 1, n = 63) and from the general population (Study 2, n = 14,010). In Study 1, participants were randomly assigned to an app-delivered mindfulness program for anxiety for two months or treatment as usual. Changes in anxiety were assessed 1 and 2 months post-treatment initiation. In studies 1-2, three phenotypes were identified: 'severely anxious with body/emotional awareness' (cluster 1), 'body/emotionally unaware' (cluster 2), and 'non-reactive and aware' (cluster 3). Study 1's results revealed a significant treatment response relative to controls (ps < 0.001) for clusters 1 and 3, but not for cluster 2. Chi-square analyses revealed that phenotypes exhibited significantly different proportions of participants with mental health diagnoses (studies 1-2). These results suggest that psychological phenotyping can bring the application of personalized medicine into clinical settings.Registry name and URL: Developing a novel digital therapeutic for the treatment of generalized anxiety disorder https://clinicaltrials.gov/ct2/show/NCT03683472?term=judson+brewer&draw=1&rank=1 .Trial registration: Registered at clinicaltrials.gov (NCT03683472) on 25/09/2018.

Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy for Depression: A Systematic Review of Cognitive Outcomes.

Objectives: Summarize existing literature on cognitive outcomes of MBSR and MBCT for individuals with depression. Methods: Following PRISMA (2021) guidance, we conducted a systematic review. We searched databases for studies published from 2000 to 2020 which examined cognitive outcomes of MBSR and MBCT in individuals with at least mild depressive symptoms. The search result in 10 studies (11 articles) meeting inclusion criteria. Results: We identified five single armed trials and five randomized controlled trials. Results indicated that three studies did not show any improvements on cognitive outcomes, and seven studies showed at least one improvement in cognitive outcomes. Conclusions: Overall, the review highlighted several inconsistencies in the literature including inconsistent use of terminology, disparate samples, and inconsistent use of methodology. These inconsistencies may help to explain the mixed results of MBSR and MBCT on cognitive outcomes. Recommendations include a more streamlined approach to studying cognitive outcomes in depressed individuals in the context of MBSR and MBCT.

Analyzing the Impact of Mobile App Engagement on Mental Health Outcomes: Secondary Analysis of the Unwinding Anxiety Program.

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.

HIV patients' perceptions of a potential multi-component mindfulness-based smoking cessation smartphone application intervention.

OBJECTIVES: Cigarette smoking rates among people living with HIV (PLWH) in the US is triple that of the general population. PLWH smokers are a high-risk group for smoking-related health disparities and should be a prime focus for smoking cessation efforts. Our team has developed a novel evidence-based Mindfulness Training (MT) smoking cessation smartphone application (app), "Craving-to-Quit." Using qualitative focus groups among PLWH smokers, this study aims to tailor and optimize the app's content and design to PLWH's unique psychosocial profile and needs. METHODS: We conducted 8 focus groups among PLWH smokers (n = 59; 47.5% females; ≥18 years) to gain insight into participants' perceptions about the app, MT, and the feasibility and acceptability of adding two additional strategies (CM: Contingency Management; self-monitoring of anti-retroviral therapies intake [ART]) to further optimize the app. Participants were asked to practice MTs and watch videos from the app presented on a screen in the conference room to discuss their experience. Sessions were audio-taped, transcribed verbatim, and analyzed thematically using NVivo. RESULTS: Most participants were non-Hispanic black (67.8%), on a federal health insurance program (61.0%). Participants considered it easy to learn the app and thought that MT is helpful in reducing stress and motivating quit attempts and were supportive of adding CM and recommended providing $20-$50 weekly cash incentives to help in quitting. Participants felt that adding self-monitoring of ART is helpful but were concerned about confidentiality in case they lost their phone. Participants recommended making the app cost-free and adding information about smoking cessation medications and the negative effects of smoking among PLWH. CONCLUSIONS: Findings will guide the development of a novel multi-component smoking cessation intervention app integrating MT, CM, and ART self-monitoring strategies. This intervention has the potential to address several barriers to quitting in PLWH. Further clinical research is needed to test this intervention.

App-Based Mindfulness Training Predicts Reductions in Smoking Behavior by Engaging Reinforcement Learning Mechanisms: A Preliminary Naturalistic Single-Arm Study.

Mindfulness training (MT) has been shown to influence smoking behavior, yet the involvement of reinforcement learning processes as underlying mechanisms remains unclear. This naturalistic, single-arm study aimed to examine slope trajectories of smoking behavior across uses of our app-based MT craving tool for smoking cessation, and whether this relationship would be mediated by the attenuating impact of MT on expected reward values of smoking. Our craving tool embedded in our MT app-based smoking cessation program was used by 108 participants upon the experience of cigarette cravings in real-world contexts. Each use of the tool involved mindful awareness to the experience of cigarette craving, a decision as to whether the participant wanted to smoke or ride out their craving with a mindfulness exercise, and paying mindful attention to the choice behavior and its outcome (contentment levels felt from engaging in the behavior). Expected reward values were computed using contentment levels experienced from the choice behavior as the reward signal in a Rescorla−Wagner reinforcement learning model. Multi-level mediation analysis revealed a significant decreasing trajectory of smoking frequency across MT craving tool uses and that this relationship was mediated by the negative relationship between MT and expected reward values (all ps < 0.001). After controlling for the mediator, the predictive relationship between MT and smoking was no longer significant (p < 0.001 before and p = 0.357 after controlling for the mediator). Results indicate that the use of our app-based MT craving tool is associated with negative slope trajectories of smoking behavior across uses, mediated by reward learning mechanisms. This single-arm naturalistic study provides preliminary support for further RCT studies examining the involvement of reward learning mechanisms underlying app-based mindfulness training for smoking cessation.

Targeting Anxiety to Improve Sleep Disturbance: A Randomized Clinical Trial of App-Based Mindfulness Training.

OBJECTIVE: Sleep disturbance is experienced by nearly 20% of Americans and is highly comorbid with anxiety. Sleep disturbances may predict the development of anxiety disorders. Mindfulness training (MT) has shown efficacy for anxiety yet remains limited by in-person-based delivery. Digitally delivered MT may target habitual worry processes, yet its effects on sleep have not been studied. This study tested if app-based MT for anxiety could reduce worry and improve sleep and examined the underlying mechanisms. METHODS: Individuals reporting worry interfering with sleep were randomized to treatment as usual (TAU; n = 40) or TAU + app-based MT (n = 40). Treatment-related changes in worry-related sleep disturbances (WRSDs), worry, nonreactivity, and anxiety were evaluated via self-report questionnaires at 1 and 2 months after treatment initiation. Fitbit devices were used to record total sleep time and estimate sleep efficiency. At 2 months, TAU received access to app-based MT, and both groups were reassessed at 4 months. RESULTS: In a modified intent-to-treat analysis, WRSD scores decreased by 27% in TAU + MT (n = 36) and 6% in TAU (n = 35) at 2 months (median [IQR] change = 11 [4.3] versus 15 [5.0], p = .001). These WRSD reductions were mediated by decreased worry, particularly improved nonreactivity (p values < .001). At 4 months, TAU reported a significant 29% reduction after beginning app-based MT at 2 months and TAU + MT maintained its gains. No significant between-group differences in average estimated total sleep time or sleep efficiency were found after 2 months of using the app. CONCLUSIONS: Few mindfulness-related apps have been evaluated for clinical efficacy and/or mechanism. Results from this study demonstrate a mechanistic link between MT and increased emotional nonreactivity, decreased worry, and reduction in reported sleep disturbances, suggesting that app-based MT may be a viable option to help individuals who report that worry interferes with their sleep.Trial Registration: ClinicalTrials.gov identifier: NCT03684057.

Mindfulness-Based Programs: Why, When, and How to Adapt?

This paper provides a framework for understanding why, when and how to adapt mindfulness-based programs (MBPs) to specific populations and contexts, based on research that developed and adapted multiple MBPs. In doing so, we hope to support teachers, researchers and innovators who are considering adapting an MBP to ensure that changes made are necessary, acceptable, effective, cost-effective, and implementable. Specific questions for reflection are provided such as (1) Why is an adaptation needed? (2) Does the theoretical premise underpinning mainstream MBPs extend to the population you are considering? (3) Do the benefits of the proposed adaptation outweigh the time and costs involved to all in research and implementation? (4) Is there already an evidenced-based approach to address this issue in the population or context? Fundamental knowledge that is important for the adaptation team to have includes the following: (1) essential ingredients of MBPs, (2) etiology of the target health outcome, (3) existing interventions that work for the health outcome, population, and context, (4) delivery systems and settings, and (5) culture, values, and communication patterns of the target population. A series of steps to follow for adaptations is provided, as are case examples. Adapting MBPs happens not only by researchers, but also by MBP teachers and developers, who endeavor to best serve the populations and contexts they work within. We hope that these recommendations for best practice provide a practical framework for skilfully understanding why, when, and how to adapt MBPs; and that this careful approach to adaptation maximizes MBP safety and efficacy.

A methodological checklist for fMRI drug cue reactivity studies: development and expert consensus.

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.

Mindfulness-based interventions among people of color: A systematic review and meta-analysis.

Objective In the United States, people of color (POC) are disproportionately affected by various sources of stress and prevalent mental and physical health issues that may benefit from Mindfulness-based Interventions (MBIs). However, effects of MBIs for POC are unclear. This meta-analysis examines the efficacy of MBIs through randomized controlled trials (RCTs) that included predominately POC (≥75% of the sample). Method: Random effects models were used to synthesize effect sizes. A total of 24 RCT samples were analyzed. Results: Samples were on average 94.4% POC and predominantly from low-income backgrounds (total N = 2,156). At post-treatment, MBIs yielded small but statistically superior outcomes to active controls (Hedges' g = 0.11) and inactive controls (g = 0.26). Compared to active controls, MBIs' effects on well-being were smaller than their effects on other outcome types. Compared to inactive controls, MBIs that focused on non-clinical populations and had higher proportion of POC had larger effect sizes. Attrition rates of MBIs did not differ from other active conditions in outpatient settings. Conclusion: Findings provide modest, preliminary empirical support for MBIs among POC. We discuss main findings, limitations, and implications for future MBI research for health promotion among POC.

A mindfulness-based mobile health (mHealth) intervention among psychologically distressed university students in quarantine during the COVID-19 pandemic: A randomized controlled trial.

This randomized controlled trial evaluated the effect of a mindfulness-based mobile health (mHealth) intervention, tailored to the pandemic context, among young adult students (N = 114) with elevated anxiety and/or depressive symptoms during quarantine in China, compared to a time- and attention-matched social support-based mHealth control. At baseline, postintervention (1 month), and 2-month follow-up, participants completed self-reports of primary outcomes (anxiety and depression), secondary outcomes (mindfulness and social support), and emotional suppression as a culturally relevant mechanism of change. Feasibility and acceptability were also evaluated. Using intent-to-treat (ITT) analysis, linear mixed effects models showed that compared to social support mHealth, mindfulness mHealth had a superior effect on anxiety (p = .024, between-group d = 0.72). Both conditions improved on depression (baseline-to-FU ds > 1.10, between-group difference not significant, d = 0.36 favoring mindfulness). There was an interaction of Emotional suppression reduction × Condition in the improvement of anxiety and depression. Further, mindfulness mHealth was demonstrated to be more feasible and acceptable in program engagement, evaluation, skills improvement, and perceived benefit. Retention was high in both conditions (>80%). The difference in self-reported adverse effect was nonsignificant (3.9% in mindfulness and 8.7% in social support). Results of this pilot trial suggest that both mindfulness and social support, delivered via mHealth, show promise in reducing distress among young adults in quarantine, with mindfulness being particularly effective in addressing anxiety. Successful implementation and dissemination of this mHealth intervention approach have the potential for addressing the psychological consequences of the pandemic. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial.

BACKGROUND: Current treatments for generalized anxiety disorder (GAD) often yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (eg, avoidance reinforcement learning). Mindfulness training (MT) has shown efficacy for anxiety; yet, widespread adoption has been limited, partly because of the difficulty in scaling in-person-based delivery. Digital therapeutics are emerging as potentially viable treatments; however, very few have been empirically validated. OBJECTIVE: The aim of this study is to test the efficacy and mechanism of an app-delivered MT that was designed to target a potential mechanism of anxiety (reinforcement learning), based on which previous studies have shown concern regarding feedback and the perpetuation of anxiety through negative reinforcement. METHODS: Individuals with GAD were recruited using social media advertisements and randomized during an in-person visit to receive treatment as usual (n=33) or treatment as usual+app-delivered MT (Unwinding Anxiety; n=32). The latter was composed of 30 modules to be completed over a 2-month period. Associated changes in outcomes were assessed using self-report questionnaires 1 and 2 months after treatment initiation. RESULTS: We randomized 65 participants in this study, and a modified intent-to-treat approach was used for analysis. The median number of modules completed by the MT group was 25.5 (IQR 17) out of 30; 46% (13/28) of the participants completed the program. In addition, the MT group demonstrated a significant reduction in anxiety (GAD-7) compared with the control group at 2 months (67% vs 14%; median change in GAD-7: -8.5 [IQR 6.5] vs -1.0 [IQR 5.0]; P<.001; 95% CI 6-10). Increases in mindfulness at 1 month (nonreactivity subscale) mediated decreases in worry at 2 months (Penn State Worry Questionnaire; P=.02) and decreases in worry at 1 month mediated reductions in anxiety at 2 months (P=.03). CONCLUSIONS: To our knowledge, this is the first report on the efficacy and mechanism of an app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT as a digital therapeutic for individuals with anxiety (number needed to treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways, resulting in tangible, clinically meaningful reductions in worry and anxiety. Evidence-based, mechanistically targeted digital therapeutics have the potential to improve health at a population level at a low cost. TRIAL REGISTRATION: ClinicalTrials.gov NCT03683472; https://clinicaltrials.gov/ct2/show/NCT03683472.

Smartband-Based Automatic Smoking Detection and Real-time Mindfulness Intervention: Protocol for a Feasibility Trial.

BACKGROUND: Smoking is the leading cause of preventable death in the United States. Smoking cessation interventions delivered by smartphone apps are a promising tool for helping smokers quit. However, currently available smartphone apps for smoking cessation have not exploited their unique potential advantages to aid quitting. Notably, few to no available apps use wearable technologies, most apps require users to self-report their smoking, and few to no apps deliver treatment automatically contingent upon smoking. OBJECTIVE: This pilot trial tests the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver brief mindfulness interventions in real time to reduce smoking. METHODS: Daily smokers (N=100, ≥5 cigarettes per day) wear a smartband for 60 days to monitor and detect smoking, notify them about their smoking events in real time, and deliver real-time brief mindfulness exercises triggered by detected smoking events or targeted at predicted smoking events. Smokers set a quit date at 30 days. A three-step intervention to reduce smoking is tested. First, participants wear a smartband to monitor and detect smoking, and notify them of smoking events in real time to bring awareness to smoking and triggers for 21 days. Next, a "mindful smoking" exercise is triggered by detected smoking events to bring a clear recognition of the actual effects of smoking for 7 days. Finally, after their quit date, a "RAIN" (recognize, allow, investigate, nonidentification) exercise is delivered to predicted smoking events (based on the initial 3 weeks of tracking smoking data) to help smokers learn to work mindfully with cravings rather than smoke for 30 days. The primary outcomes are feasibility measures of treatment fidelity, adherence, and acceptability. The secondary outcomes are smoking rates at end of treatment. RESULTS: Recruitment for this trial started in May 2021 and will continue until November 2021 or until enrollment is completed. Data monitoring and management are ongoing for enrolled participants. The final 60-day end of treatment data is anticipated in January 2022. We expect that all trial results will be available in April 2022. CONCLUSIONS: Findings will provide data and information on the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver real-time brief mindfulness interventions, and whether the intervention warrants additional testing for smoking cessation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03995225; https://clinicaltrials.gov/ct2/show/NCT03995225. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32521.