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BACKGROUND: Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes. METHODS/DESIGN: This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion. DISCUSSION: This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice. TRIAL REGISTRATION: Clinicaltrials.gov NCT01070056.

BACKGROUND: Young men who have sex with men (YMSM), particularly those who are partnered, are at unique risk for HIV. YMSM are among those at highest risk for HIV. Meanwhile, despite the fact that primary partners account for many-possibly most-new HIV infections, partnered men who have sex with men perceive themselves to be at much lower risk for HIV infection and therefore test less often than single men. In response to the risk of primary partner HIV transmission, couples HIV testing and counseling (CHTC) procedures have been developed for use in adult populations. Although promising, YMSM couples may require additional support to complete CHTC given their developmental context in which sexual and romantic relationships are relatively new, and communication skills are emergent. OBJECTIVE: The aim of this study was to test the additive benefit of adjunct treatment components tailored for YMSM, which enhance communication skills before the completion of CHTC. The intervention tests a continuum of prevention packages including assertive communication training videos and motivational interviewing focused on assisting with identification and development (MI-AID) before entering into the dyadic intervention components. This protocol is part of the Adolescent Medicine Trials Network (ATN) Scale It Up program described in this issue. METHODS: This is a comparative effectiveness trial that will be executed in 3 phases. Phase 1 will gather qualitative data related to intervention development and implementation from partnered YMSM at 4 subject recruitment venues (SRVs). Phase 2 will compare a continuum of these interventions in a pilot randomized controlled trial (RCT) at 2 SRVs. Phase 3 will compare the most successful adapted intervention package from phase 2 to CHTC as usual in a larger RCT at 4 SRVs. This phase is focused on implementation and sustainment phases of the Exploration, Preparation, Implementation, and Sustainment framework. RESULTS: =144) and follow-ups will occur at 1, 3, 6, and 9 months postintervention. CONCLUSIONS: Although MI-AID, video-based assertive communication training, and CHTC have established efficacy when administered on their own, this study will be the first to evaluate the strongest adjunctive version of these interventions to address the specific developmental needs of partnered YMSM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03386110; http://clinicaltrials.gov/ct2/show/NCT03386110 (Archived by WebCite at http://www.webcitation.org/75mlO7GCx). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11186.

BACKGROUND: IMPROVE aims to conduct a hybrid type 3 evaluation design to test the effectiveness of bundled implementation strategies on intervention fidelity of the Healthy School Start (HSS) program, while simultaneously monitoring effects on health outcomes of children and parents. The HSS is a 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parents' risk of developing type 2 diabetes. METHODS: IMPROVE is a cluster-randomized controlled trial with two arms to evaluate and compare the effects of two different bundles of implementation strategies on intervention fidelity expressed as adherence and responsiveness at 12 and 24 months (primary outcomes). Thirty schools in two municipalities will participate in the study reaching about 1400 families per school year. In stakeholder workshops, key implementation determinants were identified according to the domains of the Consolidated Framework for Implementation Research. Through a consensus process with stakeholders, two bundles of implementation strategies were tailored to address context-specific determinants. Schools randomly assigned to group 1 will receive bundle 1 (Basic) and group 2 will receive bundle 1 + 2 (Enhanced). Bundle 2 consists of external facilitation, fidelity monitoring and feedback strategies. Secondary outcomes will include change in acceptability, appropriateness, feasibility, and organisational readiness as perceived by school staff. In addition, child weight status and diet, and parents' feeding practices and risk of type 2 diabetes will be monitored. Linear and ordinal regression analysis will be used to test the effect on the primary and secondary outcomes, taking clustering and covariates into consideration where needed. Process evaluation will be conducted through key stakeholder interviews to investigate experiences of the program and perceptions on sustainability. DISCUSSION: This systematic approach to investigating the effectiveness of two different bundles of implementation strategies tailored to context-specific determinants on the fidelity of the HSS intervention will provide new insight into feasible implementation strategies and external support needed for the HSS to be effective and sustainable. Results will help inform how to bridge the gap between the research on school-based health programs and routine practice in schools. TRIAL REGISTRATION: Registered prospectively at ClinicalTrials.gov ID: NCT04984421 , registered July 30, 2021.

Background: Communication is a common element in all medical consultations, affecting a range of outcomes for doctors and patients. The increasing demand for medical students to be trained to communicate effectively has seen the emergence of interpersonal communication skills as core graduate competencies in medical training around the world. Medical schools have adopted a range of approaches to develop and evaluate these competencies. \nObjectives: To assess the effects of interventions for medical students that aim to improve interpersonal communication in medical consultations. \nSearch methods: We searched five electronic databases: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO, and ERIC (Educational Resource Information Centre) in September 2020, with no language, date, or publication status restrictions. We also screened reference lists of relevant articles and contacted authors of included studies. \nSelection criteria: We included randomised controlled trials (RCTs), cluster-RCTs (C-RCTs), and non-randomised controlled trials (quasi-RCTs) evaluating the effectiveness of interventions delivered to students in undergraduate or graduate-entry medical programmes. We included studies of interventions aiming to improve medical students' interpersonal communication during medical consultations. Included interventions targeted communication skills associated with empathy, relationship building, gathering information, and explanation and planning, as well as specific communication tasks such as listening, appropriate structure, and question style. \nData collection and analysis: We used standard methodological procedures expected by Cochrane. Two review authors independently reviewed all search results, extracted data, assessed the risk of bias of included studies, and rated the quality of evidence using GRADE. \nMain results: We found 91 publications relating to 76 separate studies (involving 10,124 students): 55 RCTs, 9 quasi-RCTs, 7 C-RCTs, and 5 quasi-C-RCTs. We performed meta-analysis according to comparison and outcome. Among both effectiveness and comparative effectiveness analyses, we separated outcomes reporting on overall communication skills, empathy, rapport or relationship building, patient perceptions/satisfaction, information gathering, and explanation and planning. Overall communication skills and empathy were further divided as examiner- or simulated patient-assessed. The overall quality of evidence ranged from moderate to very low, and there was high, unexplained heterogeneity. Overall, interventions had positive effects on most outcomes, but generally small effect sizes and evidence quality limit the conclusions that can be drawn. Communication skills interventions in comparison to usual curricula or control may improve both overall communication skills (standardised mean difference (SMD) 0.92, 95% confidence interval (CI) 0.53 to 1.31; 18 studies, 1356 participants; I² = 90%; low-quality evidence) and empathy (SMD 0.64, 95% CI 0.23 to 1.05; 6 studies, 831 participants; I² = 86%; low-quality evidence) when assessed by experts, but not by simulated patients. Students' skills in information gathering probably also improve with educational intervention (SMD 1.07, 95% CI 0.61 to 1.54; 5 studies, 405 participants; I² = 78%; moderate-quality evidence), but there may be little to no effect on students' rapport (SMD 0.18, 95% CI -0.15 to 0.51; 9 studies, 834 participants; I² = 81%; low-quality evidence), and effects on information giving skills are uncertain (very low-quality evidence). We are uncertain whether experiential interventions improve overall communication skills in comparison to didactic approaches (SMD 0.08, 95% CI -0.02 to 0.19; 4 studies, 1578 participants; I² = 4%; very low-quality evidence). Electronic learning approaches may have little to no effect on students' empathy scores (SMD -0.13, 95% CI -0.68 to 0.43; 3 studies, 421 participants; I² = 82%; low-quality evidence) or on rapport (SMD 0.02, 95% CI -0.33 to 0.38; 3 studies, 176 participants; I² = 19%; moderate-quality evidence) compared to face-to-face approaches. There may be small negative effects of electronic interventions on information giving skills (low-quality evidence), and effects on information gathering skills are uncertain (very low-quality evidence). Personalised/specific feedback probably improves overall communication skills to a small degree in comparison to generic or no feedback (SMD 0.58, 95% CI 0.29 to 0.87; 6 studies, 502 participants; I² = 56%; moderate-quality evidence). There may be small positive effects of personalised feedback on empathy and information gathering skills (low quality), but effects on rapport are uncertain (very low quality), and we found no evidence on information giving skills. We are uncertain whether role-play with simulated patients outperforms peer role-play in improving students' overall communication skills (SMD 0.17, 95% CI -0.33 to 0.67; 4 studies, 637 participants; I² = 87%; very low-quality evidence). There may be little to no difference between effects of simulated patient and peer role-play on students' empathy (low-quality evidence) with no evidence on other outcomes for this comparison. Descriptive syntheses of results that could not be included in meta-analyses across outcomes and comparisons were mixed, as were effects of different interventions and comparisons on specific communication skills assessed by the included trials. Quality of evidence was downgraded due to methodological limitations across several risk of bias domains, high unexplained heterogeneity, and imprecision of results. In general, results remain consistent in sensitivity analysis based on risk of bias and adjustment for clustering. No adverse effects were reported. \nAuthors' conclusions: This review represents a substantial body of evidence from which to draw, but further research is needed to strengthen the quality of the evidence base, to consider the long-term effects of interventions on students' behaviour as they progress through training and into practice, and to assess effects of interventions on patient outcomes. Efforts to standardise assessment and evaluation of interpersonal skills will strengthen future research efforts.

Despite many studies of language use in motivational interviewing, the vast majority have based this upon the quantitative coding of practitioner and client linguistic behaviours in order to relate these to client change outcomes. The current study aimed to investigate how clients and practitioners co-constructed the process of change using discourse analysis. Ten MI sessions for alcohol use were analysed in terms of how alcohol was verbally constructed, the functions and effects of rhetorical strategies employed and subject positions. Power and subjectivity were considered alongside these strands of analysis. The findings suggest that clients and therapists constructed alcohol as either a destroyer or facilitator, drawing upon discourses of differing degrees of power, which impacted upon the availability of client positions of agency and expertise in relation to alcohol. There was also a diversity of function within categories of client and practitioner speech. These findings have implications for clinical practice, in terms of moving beyond the recognition of ‘types of client talk’ and responding with an ‘MI consistent’ verbal behaviour, and moving towards reinvigorating the spirit of MI in relation to clinical outcome.

BACKGROUND: Anorexia nervosa (AN) is a biologically based serious mental disorder with high levels of mortality and disability, physical and psychological morbidity and impaired quality of life. AN is one of the leading causes of disease burden in terms of years of life lost through death or disability in young women. Psychotherapeutic interventions are the treatment of choice for AN, but the results of psychotherapy depend critically on the stage of the illness. The treatment response in adults with a chronic form of the illness is poor and drop-out from treatment is high. Despite the seriousness of the disorder the evidence-base for psychological treatment of adults with AN is extremely limited and there is no leading treatment. There is therefore an urgent need to develop more effective treatments for adults with AN. The aim of the Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions (MOSAIC) is to evaluate the efficacy and cost effectiveness of two outpatient treatments for adults with AN, Specialist Supportive Clinical Management (SSCM) and the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA). METHODS/DESIGN: 138 patients meeting the inclusion criteria are randomly assigned to one of the two treatment groups (MANTRA or SSCM). All participants receive 20 once-weekly individual therapy sessions (with 10 extra weekly sessions for those who are severely ill) and four follow-up sessions with monthly spacing thereafter. There is also optional access to a dietician and extra sessions involving a family member or a close other. Body weight, eating disorder- related symptoms, neurocognitive and psychosocial measures, and service use data are measured during the course of treatment and across a one year follow up period. The primary outcome measure is body mass index (BMI) taken at twelve months after randomization. DISCUSSION: This multi-center study provides a large sample size, broad inclusion criteria and a follow-up period. However, the study has to contend with difficulties directly related to running a large multi-center randomized controlled trial and the psychopathology of AN. These issues are discussed.