A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial.

Background: Poor long-term recovery outcomes after treatment (e.g., readmission to inpatient treatment) are common among individuals with substance use disorders (SUDs). In-person mindfulness-based treatments (MBTs) are efficacious for SUDs and may improve recovery outcomes. However, existing MBTs for SUD have limited public health reach, and thus scalable delivery methods are needed. A digitally-delivered MBT for SUDs may hold promise. Methods: We recently developed Mindful Journey, a smartphone app-based adjunctive MBT for improving long-term recovery outcomes. In this paper, we present details on the app and describe the protocol for a single-site pilot feasibility randomized controlled trial of Mindful Journey. In this trial, individuals (n = 34) in an early phase of outpatient treatment for SUDs will be randomized to either treatment-as-usual (TAU) plus Mindful Journey, or TAU only. The trial will focus on testing the feasibility (e.g., engagement) and acceptability of the app (e.g., perceived usability and helpfulness for recovery), as well as feasibility of study procedures (e.g., assessment completion). The trial will incorporate ecological momentary assessment before and after treatment to assess mechanisms in real-time, including mindfulness, craving, difficulties with negative emotion regulation, and savoring. To examine the sensitivity to change of outcomes (substance use, substance-related problems, and psychological distress) and mechanism variables (noted above), we will test within-treatment-condition changes over time. Discussion: The proposed pilot trial will provide important preliminary data on whether Mindful Journey is feasible and acceptable among individuals with SUDs. Trial registration: ClinicalTrials.gov NCT05109507.

The prototypical UK blood donor, homophily and blood donation: Blood donors are like you, not me.

BACKGROUND AND OBJECTIVES: Homophily represents the extent to which people feel others are like them and encourages the uptake of activities they feel people like them do. Currently, there are no data on blood donor homophily with respect to (i) people's representation of the average prototypical UK blood donor and (ii) the degree of homophily with this prototype for current donors, non-donors, groups blood services wish to encourage (ethnic minorities), those who are now eligible following policy changes (e.g., men-who-have-sex-with-men: MSM) and recipients. We aim to fill these gaps in knowledge. MATERIALS AND METHODS: We surveyed the UK general population MSM, long-term blood recipients, current donors, non-donors and ethnic minorities (n = 785) to assess perceptions of the prototypical donor in terms of ethnicity, age, gender, social class, educational level and political ideology. Homophily was indexed with respect to age, gender and ethnicity. RESULTS: The prototypical UK blood donor is perceived as White, middle-aged, middle-class, college-level educated and left-wing. Current donors and MSM are more homophilous with this prototype, whereas recipients and ethnic minorities have the lowest homophily. Higher levels of homophily are associated with an increased likelihood of committing to donate. CONCLUSION: The prototype of the UK donor defined this as a White activity. This, in part, may explain why ethnic minorities are less likely to be donors. As well as traditional recruitment strategies, blood services need to consider broader structural changes such as the ethnic diversity of staff and co-designing donor spaces with local communities.

Food Insecurity Associated with Higher Stress, Depressive Symptoms, and Lower Diet Quality among Women Caregivers in North Carolina.

BACKGROUND: Research suggests a bidirectional relationship between food insecurity and stress, but few studies have examined associations of food insecurity with stress and other indicators of cardiometabolic health, including depression, diet quality, and body weight, among lower-income women in the U.S. METHODS: This cross-sectional study analyzed data from lower-income women caregivers living in North Carolina (n = 100): 42% Black/African American, 25% Hispanic/Latina, and 33% White women. Multivariable linear regression models were used to determine associations of food insecurity status with perceived stress, depressive symptoms, diet quality, and body mass index (BMI). Multivariable logistic regression models were used to determine associations of food insecurity with clinical depression and BMI ≥ 30 kg/m2. Associations were examined with and without adjustment for perceived stress. RESULTS: Forty-two percent of the sample were experiencing food insecurity. Compared to food secure caregivers, food-insecure caregivers had significantly higher perceived stress (ß: +7.51; 95%CI: 4.19, 10.84) and depressive symptoms (ß: +3.55; 95%CI: 0.54, 6.56) and lower diet quality (ß: -9.10; 95%CI: -15.81, -2.40). Associations with BMI outcomes were not statistically significant. CONCLUSION: Findings support removing stigma in nutrition assistance programs and clinical interactions, motivate future longitudinal studies, and inform the development of destigmatizing interventions for health promotion or disease prevention.

Singing for lung health in COPD: a multicentre randomised controlled trial of online delivery.

BACKGROUND: Singing for lung health (SLH) is an arts-based breathing control and movement intervention for people with long-term respiratory conditions, intended to improve symptoms and quality of life. Online, remotely delivered programmes might improve accessibility; however, no previous studies have assessed the effectiveness of this approach. METHODS: We conducted an assessor-blind randomised controlled trial comparing the impact of 12 weeks of once-weekly online SLH sessions against usual care on health-related quality of life, assessed using the RAND 36-Item Short Form Health Survey (SF-36) Mental Health Composite (MHC) and Physical Health Composite (PHC) scores. RESULTS: We enrolled 115 people with stable chronic obstructive pulmonary disease (COPD), median (IQR) age 69 (62-74), 56.5% females, 80% prior pulmonary rehabilitation, Medical Research Council dyspnoea scale 4 (3-4), forced expiratory volume in 1 s % predicted 49 (35-63). 50 participants in each arm completed the study. The intervention arm experienced improvements in physical but not mental health components of RAND SF-36; PHC (regression coefficient (95% CI): 1.77 (95% CI 0.11 to 3.44); p=0.037), but not MHC (0.86 (95% CI -1.68 to 3.40); p=0.504). A prespecified responder analysis based on achieving a 10% improvement from baseline demonstrated a response rate for PHC of 32% in the SLH arm and 12.7% for usual care (p=0.024). A between-group difference in responder rate was not found in relation to the MHC (19.3% vs 25.9%; p=0.403). DISCUSSION AND CONCLUSION: A 12-week online SLH programme can improve the physical component of quality of life for people with COPD, but the overall effect is relatively modest compared with the impact seen in research using face-to-face group sessions. Further work on the content, duration and dose of online interventions may be useful. TRIAL REGISTRATION NUMBER: NCT04034212.

A multisite feasibility randomized clinical trial of mindfulness-based resilience training for aggression, stress, and health in law enforcement officers.

BACKGROUND: Law enforcement officers (LEOs) are exposed to significant stressors that can impact their mental health, increasing risk of posttraumatic stress disorder, burnout, at-risk alcohol use, depression, and suicidality. Compromised LEO health can subsequently lead to aggression and excessive use of force. Mindfulness training is a promising approach for high-stress populations and has been shown to be effective in increasing resilience and improving mental health issues common among LEOs. METHODS: This multi-site, randomized, single-blind clinical feasibility trial was intended to establish optimal protocols and procedures for a future full-scale, multi-site trial assessing effects of mindfulness-based resilience training (MBRT) versus an attention control (stress management education [SME]) and a no-intervention control, on physiological, attentional, and psychological indices of stress and mental health. The current study was designed to enhance efficiency of recruitment, engagement and retention; optimize assessment, intervention training and outcome measures; and ensure fidelity to intervention protocols. Responsiveness to change over time was examined to identify the most responsive potential proximate and longer-term assessments of targeted outcomes. RESULTS: We observed high feasibility of recruitment and retention, acceptability of MBRT, fidelity to assessment and intervention protocols, and responsiveness to change for a variety of putative physiological and self-report mechanism and outcome measures. CONCLUSIONS: Results of this multi-site feasibility trial set the stage for a full-scale, multi-site trial testing the efficacy of MBRT on increasing LEO health and resilience, and on decreasing more distal outcomes of aggression and excessive use of force that would have significant downstream benefits for communities they serve. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03784846 . Registered on December 24th, 2018.

Activity counseling early postelective percutaneous coronary intervention (ACE-PCI): Mixed-methods pilot randomized controlled trial.

Background: Physical activity (PA) levels of people with coronary heart disease are low in the first 30 days after percutaneous coronary intervention (PCI), increasing the risk of recurrent cardiac events. Following PCI, PA counseling delivered by a physiotherapist before discharge may increase the PA levels of patients. Preliminary work is required to determine the effects of the counseling session compared to usual care. Objectives: To investigate the feasibility and potential efficacy of a brief physiotherapist-led PA counseling session immediately after an elective PCI compared to usual care for improved PA early post-PCI. Methods: Using concealed allocation and blinded assessments, eligible participants (n = 30) were randomized to a physiotherapist-led PA counseling session (30 min) or usual care (nurse-led PA advice < 5 min). The primary outcome was daily minutes of moderate-to-vigorous PA (accelerometry; 3 weeks). Secondary outcomes included cardiac rehabilitation intention, anxiety and depression levels (Hospital Anxiety and Depression Scale), and quality-of-life (MacNew questionnaire). Recruitment, retention, and attrition were assessed for feasibility. Semistructured interviews were conducted with 13 participants to determine intervention acceptability, and barriers and enablers to PA. Results: Between and within-group comparisons were not significant in intention-to-treat analyses. All feasibility criteria were met except for retention and attrition of participants. At 3 weeks, only 25% of participants were planning to attend cardiac rehabilitation, with no between-group differences. Increased PA at 3 weeks was associated with participants that were younger, without other chronic disease,s and more active immediately following discharge. Interviews revealed personal, environmental, and program-based themes for barriers and enablers to PA. Conclusions: A physiotherapist-led PA counseling session may not improve PA levels early post-elective PCI compared to very brief PA advice delivered by nurses. A larger multicentre randomized controlled trial is feasible with minor modifications to participant follow-up. Further research is required.

Development and initial testing of mindful journey: a digital mindfulness-based intervention for promoting recovery from Substance use disorder.

BACKGROUND/OBJECTIVES: There is a great unmet need for accessible adjunctive interventions to promote long-term recovery from substance use disorder (SUD). This study aimed to iteratively develop and test the initial feasibility and acceptability of Mindful Journey, a novel digital mindfulness-based intervention for promoting recovery among individuals with SUD. PATIENTS/MATERIALS: Ten adults receiving outpatient treatment for SUD. METHODS: Phase 1 (n = 5) involved developing and testing a single introductory digital lesson. Phase 2 included a separate sample (n = 5) and involved testing all 15 digital lessons (each 30- to 45-minutes) over a 6-week period, while also receiving weekly brief phone coaching for motivational/technical support. RESULTS: Across both phases, quantitative ratings (rated on a 5-point scale) were all at or above a 4 (corresponding with 'agree') for key acceptability dimensions, such as usability, understandability, appeal of visual content, how engaging the content was, and helpfulness for recovery. Additionally, in both phases, qualitative feedback indicated that participants particularly appreciated the BOAT (Breath, Observe, Accept, Take a Moment) tool for breaking down mindfulness into steps. Qualitative feedback was used to iteratively refine the intervention. For example, based on feedback, we added a second core mindfulness tool, the SOAK (Stop, Observe, Appreciate, Keep Curious), and we added more example clients and group therapy videos. In Phase 2, 4 out of 5 participants completed all 15 lessons, providing initial evidence of feasibility. Participants reported that the phone coaching motivated them to use the app. The final version of Mindful Journey was a smartphone app with additional features, including brief on-the-go audio exercises and a library of mindfulness practices. Although, participants used these additional features infrequently. CONCLUSIONS: Based on promising initial findings, future acceptability and feasibility testing in a larger sample is warranted. Future versions might include push notifications to facilitate engagement in the additional app features.

As low as reasonably practicable (ALARP): a moral model for clinical risk management in the setting of technology dependence.

Children dependent on life-prolonging medical technology are often subject to a constant background risk of sudden death or catastrophic complications. Such children can be cared for in hospital, in an intensive care environment with highly trained nurses and doctors able to deliver specialised, life-saving care immediately. However, remaining in hospital, when life expectancy is limited, can considered to be a harm in of itself. Discharge home offers the possibility for an improved quality of life for the child and their family but comes with significant medical risks.When making decisions for children, two ethical models predominate, the promotion of the child's best interests or the avoidance of harm. However, in some circumstances, particularly for children with life-limiting and/or life-threatening illness, all options may be associated with risk. There are no good options, only potentially harmful choices.In this paper, we explore decisions made by one family in such circumstances. We describe a model adopted from risk management programmes beyond medicine, which offers a potential framework for identifying risks to the child that are morally permissible. Some risks and harms to a child, not ordinarily permitted, may be acceptable when undertaken in the pursuit of a specified desired good, so long as they are as low as reasonably practicable.

Testing the Effect of a Smartphone App on Hospital Admissions and Sedentary Behavior in Cardiac Rehabilitation Participants: ToDo-CR Randomized Controlled Trial.

BACKGROUND: People with coronary heart disease are at an increased risk of morbidity and mortality even if they attend cardiac rehabilitation. High sedentary behavior levels potentially contribute to this morbidity. Smartphone apps may be feasible to facilitate sedentary behavior reductions and lead to reduced health care use. OBJECTIVE: We aimed to test the effect of a sedentary behavior change smartphone app (Vire app and ToDo-CR program) as an adjunct to cardiac rehabilitation on hospital admissions and emergency department (ED) presentations over 12 months. METHODS: A multicenter, randomized controlled trial was conducted with 120 participants recruited from 3 cardiac rehabilitation programs. Participants were randomized 1:1 to cardiac rehabilitation plus the fully automated 6-month Vire app and ToDo-CR program (intervention) or usual care (control). The primary outcome was nonelective hospital admissions and ED presentations over 12 months. Secondary outcomes including accelerometer-measured sedentary behavior, BMI, waist circumference, and quality of life were recorded at baseline and 6 and 12 months. Logistic regression models were used to analyze the primary outcome, and linear mixed-effects models were used to analyze secondary outcomes. Data on intervention and hospital admission costs were collected, and the incremental cost-effectiveness ratios (ICERs) were calculated. RESULTS: Participants were, on average, aged 62 (SD 10) years, and the majority were male (93/120, 77.5%). The intervention group were more likely to experience all-cause (odds ratio [OR] 1.54, 95% CI 0.58-4.10; P=.39) and cardiac-related (OR 3.26, 95% CI 0.84-12.55; P=.09) hospital admissions and ED presentations (OR 2.07, 95% CI 0.89-4.77; P=.09) than the control group. Despite this, cardiac-related hospital admission costs were lower in the intervention group over 12 months (Aus $252.40 vs Aus $859.38; P=.24; a currency exchange rate of Aus $1=US $0.69 is applicable). There were no significant between-group differences in sedentary behavior minutes per day over 12 months, although the intervention group completed 22 minutes less than the control group (95% CI -22.80 to 66.69; P=.33; Cohen d=0.21). The intervention group had a lower BMI (ß=1.62; P=.05), waist circumference (ß=5.81; P=.01), waist-to-hip ratio (ß=.03, P=.03), and quality of life (ß=3.30; P=.05) than the control group. The intervention was more effective but more costly in reducing sedentary behavior (ICER Aus $351.77) and anxiety (ICER Aus $10,987.71) at 12 months. The intervention was also more effective yet costly in increasing quality of life (ICER Aus $93,395.50) at 12 months. CONCLUSIONS: The Vire app and ToDo-CR program was not an outcome-effective or cost-effective solution to reduce all-cause hospital admissions or ED presentations in cardiac rehabilitation compared with usual care. Smartphone apps that target sedentary behavior alone may not be an effective solution for cardiac rehabilitation participants to reduce hospital admissions and sedentary behavior. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001223123; https://australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619001223123. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2020-040479.

Warming up cool cooperators.

Explaining why someone repeats high-cost cooperation towards non-reciprocating strangers is difficult. Warm glow offers an explanation. We argue that warm glow, as a mechanism to sustain long-term cooperation, cools off over time but can be warmed up with a simple intervention message. We tested our predictions in the context of repeat voluntary blood donation (high-cost helping of a non-reciprocating stranger) across 6 studies: a field-based experiment (n = 5,821) comparing warm-glow and impure-altruism messages; an implementation study comparing a 3-yr pre-implementation period among all first-time donors in Australia (N = 270,353) with a 2-yr post-implementation period (N = 170, 317); and 4 studies (n = 716, 1,124, 932, 1,592) exploring mechanisms. We show that there are relatively warm and cool cooperators, not cooling cooperators. Cooperation among cool cooperators is enhanced by a warm-glow-plus-identity message. Furthermore, the behavioural facilitation of future cooperation, by booking an appointment, is associated with being a warm cooperator. Societal implications are discussed.

Efficacy of mindfulness-based relapse prevention in a sample of veterans in a substance use disorder aftercare program: A randomized controlled trial.

BACKGROUND: Complementary integrative medicine, such as mindfulness-based interventions, (MBI) have demonstrated efficacy in the treatment of depression, anxiety, substance use disorders (SUDs), and pain. Mindfulness-based relapse prevention (MBRP) is an aftercare intervention targeting SUD relapse that integrates cognitive-behavioral relapse prevention and mindfulness meditation practices, raising awareness of substance use triggers and reactive behavioral patterns. This study evaluated the efficacy of MBRP in reducing relapse in veterans following completion of an SUD treatment program. METHODS: This study was a two-site, randomized controlled trial comparing MBRP to 12-step facilitation (TSF) aftercare in military veterans following completion of intensive treatment for SUDs. The 8 weeks of 90-minute, group-based MBRP or TSF sessions were followed by 3-, 6- and 10-month follow-up periods with assessments of alcohol/substance use and secondary outcomes of depression, anxiety, and mindfulness. RESULTS: Forty-seven percent of veterans attended ≥75 % of sessions. Veterans in both the MBRP and TSF aftercare groups maintained reductions in alcohol and illicit substance use during the aftercare treatment. Nineteen participants (11 %; 19/174) reported returning to alcohol use during the study treatment period and the study found no difference between study groups [MBRP: 9 % vs. TSF 13 %; p = 0.42]. Thirteen participants (7.5 %; 13/174) reported a return to illicit substance use during study treatment [MBRP: 5.4 % vs. TSF 10.3 % p = 0.34]. The number of days of drinking and illicit substance use was not different between groups (alcohol, p = 0.53; illicit substance use, p = 0.28). CONCLUSION: Although retention in treatment limits interpretation of the findings, both MBRP and TSF were effective in maintenance of treatment gains following an intensive treatment program for veterans with SUDs. Future studies should focus on strategies to improve treatment participation.

Mediating Effects of Thought Suppression in the Relationship Between Mindfulness and Substance Use Craving.

Background: Substance use disorder (SUD) is a significant issue in the United States, characterized by chronic relapse following periods of abstinence. One of the primary precursors to relapse is craving. Findings from several studies have shown a negative association between trait mindfulness and craving in clinical samples; however, further research is needed to understand mechanisms underlying this relationship. Purpose/Objectives: The current study assessed thought suppression as a partial mediator of the relationship between trait mindfulness and craving. Methods: The current study used data from a previous randomized controlled trial of adults (N = 244) enrolled in community-based treatment for substance use disorder (SUD). Results: Analyses showed a significant moderate positive association between thought suppression and craving, a significant moderate negative association between thought suppression and trait mindfulness, and a significant moderate negative association between trait mindfulness and craving. Subsequent analyses confirmed a partial mediating role of thought suppression in the relationship between trait mindfulness and craving, indicating the inverse relationship between trait mindfulness and craving was partially explained by thought suppression. Conclusions/importance: These findings may inform treatment for SUD. Specifically, targeting thought suppression through mindfulness-based treatment approaches may be a mechanism through which craving can be reduced.

Development of a mobile mindfulness smartphone app for post-traumatic stress disorder and alcohol use problems for veterans: Beta test results and study protocol for a pilot randomized controlled trial.

BACKGROUND: Post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are highly prevalent, and co-occurring among post-9/11 veterans. Mobile health (mHealth) applications, specifically those focused on mindfulness-based techniques, may be an effective avenue to intervene with veterans who cannot or will not seek care at traditional in-person settings. Thus, to address areas of improvement in mHealth for veterans, we developed Mind Guide and prepared it for testing in a pilot randomized controlled trial (RCT) with veterans. METHODS: We have completed phase 1 (treatment development) and Phase 2 (beta test) of our mobile mHealth app, Mind Guide. In this paper we describe the methods for Phase 1 as well as results for our beta test (n = 16; inclusion criteria included screen for PTSD, AUD, a post-9/11 veteran, and not currently receiving treatment) for Mind Guide as well as outline procedures for our pilot RCT of Mind Guide (Phase 3). The PTSD Checklist, self-reported alcohol use, the Perceived Stress Scale, Penn Alcohol Craving Scale, and the Emotion Regulation Questionnaire were used. RESULTS: Results of our beta test of Mind Guide show promising past 30 day effects on PTSD (d = -1.12), frequency of alcohol use (d = -0.54), and alcohol problems (d = -0.44), and related mechanisms of craving (d = -0.53), perceived stress (d = -0.88), and emotion regulation (d = -1.22). CONCLUSION: Our initial beta-test of Mind Guide shows promise for reducing PTSD and alcohol related problems among veterans. Recruitment is ongoing for our pilot RCT in which 200 veterans will be recruited and followed up for 3 months. CLINICALTRIALS: gov Identifier: NCT04769986.

Can uptake of childhood influenza immunisation through schools and GP practices be increased through behaviourally-informed invitation letters and reminders: two pragmatic randomized controlled trials.

BACKGROUND: The UK is rolling out a national childhood influenza immunisation programme for children, delivered through primary care and schools. Behaviourally-informed letters and reminders have been successful at increasing uptake of other public health interventions. Therefore, we investigated the effects of a behaviourally-informed letter on uptake of the vaccine at GP practices, and of a letter and a reminder (SMS/ email) on uptake at schools. METHODS AND RESULTS: Study 1 was a cluster-randomised parallel trial of 21,786 two- and three-year olds in 250 GP practices, conducted during flu season (September to January inclusive) 2016/7. The intervention was a centrally-sent behaviourally-informed invitation letter, control was usual care. The proportion of two- and three-year olds in each practice who received a vaccination by 31st January 2017 was 23.4% in the control group compared to 37.1% in the intervention group (OR = 1.93; 95% CI = 1.82, 2.05, p <  0.001). Study 2 was a 2 (behavioural letter vs standard letter) × 2 (reminder vs no reminder) factorial trial of 1108 primary schools which included 3010 school years 1-3. Letters were sent to parents from providers, and reminders sent to parents from the schools. In the standard-letter-no-reminder arm, an average of 61.6% of eligible children in each school year were vaccinated, compared to 61.9% in the behavioural-letter-no-reminder arm, 63.5% in the standard-letter-plus-reminder arm, and 62.9% in the behavioural-letter-plus reminder condition, F(3, 2990) = 2.68, p = 0.046. In a multi-level model, with demographic variables as fixed effects, the proportion of eligible students in the school year who were vaccinated increased with the reminder, ß = 0.086 (0.041), p <  0.036, but there was no effect of the letter nor any interaction effect. CONCLUSION: Sending a behaviourally informed invitation letter can increase uptake of childhood influenza vaccines at the GP surgery compared to usual practice. A reminder SMS or email can increase uptake of the influenza vaccine in schools, but the effect size was minimal. TRIAL REGISTRATION: Study 1: Trial registration: ClinicalTrials.gov Identifier: NCT02921633. Study 2: Trial registration: ClinicalTrials.gov Identifier: NCT02883972.

Communicating the move to individualized donor selection policy: Framing messages focused on recipients and safety.

BACKGROUND: Men-who-have-sex-with-men (MSM) have been deferred from donating blood. However, recent evidence supports the adoption of donor screening based on individuals' sexual behavior over population-based criteria. We explore how best to frame communications about adopting this change to minimize any potential negative consequences (e.g., reduced donor numbers). We examine the effectiveness of risk (emphasizing safety vs. emphasizing low risk), and focus (donor vs. recipient) frames on intentions to donate blood (approach) or feeling deterred from donating (avoid), and mechanisms linked to under-reporting sexual behavior. STUDY DESIGN AND METHODS: We conducted a 2 (risk frame: risk vs. safety) by 3 (focus: donor vs. recipient vs. both) between-subjects online experiment (n = 2677). The main outcomes were intentions to donate and feelings of being put-off/deterred from donating (both for self and others). We also assessed the extent that forgetting, embarrassment/shame, and question irrelevance were perceived to be associated with under-reporting sexual behavior. RESULTS: Frames that focused on safety or a recipient resulted in people reporting being less deterred from donating. Regardless of frame, people from ethnic minorities were more likely to feel deterred. Embarrassment/shame followed by forgetting and perceived irrelevance were the main reasons for under-reporting sexual behaviors, especially in ethnic minorities, and smartphones were perceived as an acceptable memory aid for sexual behavior. DISCUSSION: Blood services moving to an individualized policy should frame donor selection in terms of safety and/or a recipient focus, explore sensitivities in ethnic minority communities, consider ways to normalize reporting sexual behavior, and use smartphones as a memory aid.

Using text and charts to provide social norm feedback to general practices with high overall and high broad-spectrum antibiotic prescribing: a series of national randomised controlled trials.

BACKGROUND: Sending a social norms feedback letter to general practitioners who are high prescribers of antibiotics has been shown to reduce antibiotic prescribing. The 2017-9 Quality Premium for primary care in England sets a target for broad-spectrum prescribing, which should be at or below 10% of total antibiotic prescribing. We tested a social norm feedback letter that targeted broad-spectrum prescribing and the addition of a chart to a text-only letter that targeted overall prescribing. METHODS: We conducted three 2-armed randomised controlled trials, on different groups of practices: Trial A compared a broad-spectrum message and chart to the standard-practice overall prescribing letter (practices whose percentage of broad-spectrum prescribing was above 10% and who had relatively high overall prescribing). Trial C compared a broad-spectrum message and a chart to a no-letter control (practices whose percentage of broad-spectrum prescribing was above 10% and who had relatively moderate overall prescribing). Trial B compared an overall-prescribing message with a chart to the standard practice overall letter (practices whose percentage of broad-spectrum prescribing was below 10% but who had relatively high overall prescribing). Letters were posted to general practitioners, timed to be received on 1 November 2018. The primary outcomes were practices' percentage of broad-spectrum prescribing (trials A and C) and overall antibiotic prescribing (trial B) each month from November 2018 to April 2019 (all weighted by the number and characteristics of patients registered in the practice). RESULTS: We randomly assigned 1909 practices; 58 closed or merged during the trial, leaving 1851 practices: 385 in trial A, 674 in trial C, and 792 in trial B. AR(1) models showed that there were no statistically significant differences in our primary outcome measures: trial A ß = - .199, p = .13; trial C ß = .006, p = .95; trial B ß = - .0021, p = .81. In all three trials, there were statistically significant time trends, showing that overall antibiotic prescribing and total broad-spectrum prescribing were decreasing. CONCLUSION: Our broad-spectrum feedback letters had no effect on broad-spectrum prescribing; adding a bar chart to a text-only letter had no effect on overall antibiotic prescribing. Broad-spectrum and overall prescribing were both decreasing over time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03862794. March 5, 2019.

Trauma-Integrated Mindfulness-Based Relapse Prevention for Women with Comorbid Post-Traumatic Stress Disorder and Substance Use Disorder: A Cluster Randomized Controlled Feasibility and Acceptability Trial.

Background: Comorbid post-traumatic stress disorder and substance use disorder (PTSD-SUD) among women receiving substance use treatment are common. Few evidence-based interventions target PTSD-SUD, however, fewer are gender responsive. Mindfulness-based relapse prevention (MBRP) has shown effectiveness for women with SUD, although it does not explicitly target PTSD. Integration of trauma-focused and gender-responsive treatments into MBRP may address the limited availability of PTSD-SUD interventions for women. This study assessed feasibility and acceptability of trauma-integrated MBRP (TI-MBRP). Methods: A single-blind computer-generated cluster-randomized design was employed in which women with PTSD-SUD (N = 83) received either TI-MBRP (k = 5) or MBRP (k = 5). Measures of PTSD symptom severity and craving were administered at pre-, post-, 1-, 3-, 6-, 9-, and 12-month follow-up and assessed at the individual level. Results: TI-MBRP demonstrated acceptability among participants; however, attrition was high (64%) at 12-month follow-up. Reductions in PTSD were greater in the MBRP than in the TI-MBRP group at postcourse and 1-month follow-up, and there were significant reductions in PTSD severity and craving over the 12-month period in both conditions. Conclusions: Integrating trauma- and gender-focused interventions into MBRP was feasible and acceptable. MBRP alone may be effective in reducing both PTSD and SUD symptoms in women with PTSD-SUD; however, confirmatory studies are warranted. Clinical Trial Registration Number: NCT03505749.

Effects of Mindfulness-Based Relapse Prevention on the Chronic use of Hypnotics in Treatment-Seeking Women with Insomnia: a Randomized Controlled Trial.

BACKGROUND: Hypnotics are one of the most frequently prescribed drugs worldwide, especially for women, and their chronic use may lead to tolerance, dosage escalation, dependence, withdrawal syndrome, and cognitive impairments, representing a significant public health problem. Consistent evidence from previous studies shows benefits of mindfulness-based interventions (MBIs) for substance use disorders (SUD) and insomnia. However, to date, there is a lack of research about effects of MBIs on reduction/cessation of chronic hypnotic use among women with insomnia. METHOD: The present randomized trial evaluated the efficacy of the 8-week group-delivered mindfulness-based relapse prevention (MBRP) program in an intervention group (IG, n = 34) compared with weekly phone monitoring only in the control group (CG, n = 36) in reducing hypnotic use and insomnia severity over a 6-month follow-up period. RESULTS: There were significant differences between groups at baseline regarding hypnotic use but not insomnia. Group effects on hypnotic use were found immediately after the intervention (bT1 = 2.01, p < 0.001) and at the 2-month follow-up (bT2 = 2.21, p < 0.001), favoring the IG. The IG also had a greater reduction from baseline levels than the control group in insomnia severity at the 4-month (bT3 = 0.21, p = 0.045) and 6-month (bT4 = 0.32, p = 0.002) follow-ups. CONCLUSIONS: The findings provide preliminary evidence of benefits of MBRP for reducing insomnia severity and potentially chronic hypnotic use. However, IG effects on chronic hypnotic use may have resulted from IG and control group differences in chronic hypnotic use at baseline. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02127411.