The short and long-term efficacy of nurse-led interventions for improving blood pressure control in people with hypertension in primary care settings: a systematic review and meta-analysis.

BACKGROUND: Previous systematic reviews suggest that nurse-led interventions improve short-term blood pressure (BP) control for people with hypertension. However, the long-term effects, adverse events, and appropriate target BP level are unclear. This study aimed to evaluate the long-term efficacy and safety of nurse-led interventions. METHODS: We conducted a systematic review and meta-analysis. We searched the Cochrane Central Register of Controlled Trials, PubMed, and CINAHL, as well as three Japanese article databases, as relevant randomized controlled trials from the oldest possible to March 2021. This search was conducted on 17 April 2021. We did an update search on 17 October 2023. We included studies on adults aged 18 years or older with hypertension. The treatments of interest were community-based nurse-led BP control interventions in addition to primary physician-provided care as usual. The comparator was usual care only. Primary outcomes were long-term achievement of BP control goals and serious adverse events (range: 27 weeks to 3 years). Secondary outcomes were short-term achievement of BP control goals and serious adverse events (range: 4 to 26 weeks), change of systolic and diastolic BP from baseline, medication adherence, incidence of hypertensive complications, and total mortality. RESULTS: We included 35 studies. Nurse-led interventions improved long-term BP control (RR 1.10, 95%CI 1.03 to 1.18). However, no significant differences were found in the short-term effects of nurse-led intervention compared to usual care about BP targets. Little information on serious adverse events was available. There was no difference in mortality at both terms between the two groups. Establishing the appropriate target BP from the extant trials was impossible. CONCLUSIONS: Nurse-led interventions may be more effective than usual care for achieving BP control at long-term follow-up. It is important to continue lifestyle modification for people with hypertension. We must pay attention to adverse events, and more studies examining appropriate BP targets are needed. Nurse-led care represents an important complement to primary physician-led usual care.

Cardiotocography use for fetal assessment during labor in low- and middle-income countries: A scoping review.

BACKGROUND: The use of cardiotocography (CTG) to improve neonatal outcomes is controversial. The medical settings, subjects, utilizations, and interpretation guidelines of CTG are unclear for low- and middle-income countries (LMICs). OBJECTIVES: To assess and review CTG use for studies identified in LMICs and provide insights on the potential for effective use of CTG to improve maternal and neonatal outcomes. SEARCH STRATEGY: The databases Medline, CINAHL, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for published and unpublished literature through September 2023. SELECTION CRITERIA: Publications were identified which were conducted in LMICs, based on the World Bank list of economies for 2019; targeting pregnant women in childbirth; and focusing on the utilization of CTG and neonatal outcomes. DATA COLLECTION AND ANALYSIS: Publications were screened, and duplicates were removed. A scoping review was conducted using PRISMA-ScR guidelines. RESULTS: The searches generated 1157 hits, of which 67 studies were included in the review. In the studies there was considerable variation and ambiguity regarding the study settings, target populations, utilizations, timing, frequency, and duration of CTG. While cesarean section rates were extensively investigated as an outcome of studies of CTG itself and the effect of additional techniques on CTG, other clinically significant outcomes, including neonatal mortality, were not well reported. CONCLUSIONS: Variations and ambiguities were found in the use of CTG in LMICs. Due to the limited amount of evidence, studies are needed to examine CTG availability in the context of LMICs.

Three types of university students with subthreshold depression characterized by distinctive cognitive behavioral skills.

Subthreshold depression impairs young people's quality of life and places them at greater risk of developing major depression. Cognitive behavioral therapy (CBT) is an evidence-based approach for addressing such depressive states. This study identified subtypes of university students with subthreshold depression and revealed discrete profiles of five CBT skills: self-monitoring, cognitive restructuring, behavioral activation, assertive communication, and problem solving. Using data from the Healthy Campus Trial (registration number: UMINCTR-000031307), a hierarchical clustering analysis categorized 1,080 students into three clusters: Reflective Low-skilled, Non-reflective High-skilled, and Non-reflective Low-skilled students. Non-reflective Low-skilled students were significantly more depressed than other students (p < .001). The severity of depression seemed to be related to the combination of self-monitoring skills and other CBT skills. Considering the high prevalence of poor self-monitoring skills in persons with autism, the most severe depression was observed in the significant association between Non-reflective Low-skilled students and autistic traits (p = .008). These findings suggest that subthreshold depression can be categorized into three subtypes based on CBT skill profiles. The assessment of autistic traits is also suggested when we provide CBT interventions for Non-reflective Low-skilled students.

Four 2×2 factorial trials of smartphone CBT to reduce subthreshold depression and to prevent new depressive episodes among adults in the community-RESiLIENT trial (Resilience Enhancement with Smartphone in LIving ENvironmenTs): a master protocol.

INTRODUCTION: The health burden due to depression is ever increasing in the world. Prevention is a key to reducing this burden. Guided internet cognitive-behavioural therapies (iCBT) appear promising but there is room for improvement because we do not yet know which of various iCBT skills are more efficacious than others, and for whom. In addition, there has been no platform for iCBT that can accommodate ongoing evolution of internet technologies. METHODS AND ANALYSIS: Based on our decade-long experiences in developing smartphone CBT apps and examining them in randomised controlled trials, we have developed the Resilience Training App Version 2. This app now covers five CBT skills: cognitive restructuring, behavioural activation, problem-solving, assertion training and behaviour therapy for insomnia. The current study is designed as a master protocol including four 2×2 factorial trials using this app (1) to elucidate specific efficacies of each CBT skill, (2) to identify participants' characteristics that enable matching between skills and individuals, and (3) to allow future inclusion of new skills. We will recruit 3520 participants with subthreshold depression and ca 1700 participants without subthreshold depression, to examine the short-term efficacies of CBT skills to reduce depressive symptoms in the former and to explore the long-term efficacies in preventing depression in the total sample. The primary outcome for the short-term efficacies is the change in depressive symptoms as measured with the Patient Health Questionnaire-9 at week 6, and that for the long-term efficacies is the incidence of major depressive episodes as assessed by the computerised Composite International Diagnostic Interview by week 50. ETHICS AND DISSEMINATION: The trial has been approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1556). TRIAL REGISTRATION NUMBER: UMIN000047124.

Prognostic factors and effect modifiers for personalisation of internet-based cognitive behavioural therapy among university students with subthreshold depression: A secondary analysis of a factorial trial.

BACKGROUND: Internet-cognitive behavioural therapy (iCBT) for depression can include multiple components. This study explored depressive symptom improvement prognostic factors (PFs) and effect modifiers (EMs) for five common iCBT components including behavioural activation, cognitive restructuring, problem solving, self-monitoring, and assertion training. METHODS: We used data from a factorial trial of iCBT for subthreshold depression among Japanese university students (N = 1093). The primary outcome was the change in PHQ-9 scores at 8 weeks from baseline. Interactions between each component and various baseline characteristics were estimated using a mixed-effects model for repeated measures. We calculated multiplicity-adjusted p-values at 5 % false discovery rate using the Benjamini-Hochberg procedure. RESULTS: After multiplicity adjustment, the baseline PHQ-9 total score emerged as a PF and exercise habits as an EM for self-monitoring (adjusted p-values <0.05). The higher the PHQ-9 total score at baseline (range: 5-14), the greater the decrease after 8 weeks. For each 5-point increase at baseline, the change from baseline to 8 weeks was bigger by 2.8 points. The more frequent the exercise habits (range: 0-2 points), the less effective the self-monitoring component. The difference in PHQ-9 change scores between presence or absence of self-monitoring was smaller by 0.94 points when the participant exercised one level more frequently. Additionally, the study suggested seven out of 36 PFs and 14 out of 160 EMs examined were candidates for future research. LIMITATIONS: Generalizability is limited to university students with subthreshold depression. CONCLUSIONS: These results provide some helpful information for the future development of individualized iCBT algorithms for depression.

Validation of the Japanese Big Five Scale Short Form in a University Student Sample.

The Japanese Big Five Scale Short Form (JBFS-SF), a 29-item self-report scale, has recently been used to measure the Big Five personality traits. However, the scale lacks psychometric validation. This study examined the validity and reliability of the JBFS-SF with data collected from 1,626 Japanese university students participating in a randomized controlled clinical trial. Structural validity was tested with exploratory and confirmatory factor analysis and measurement invariance tests were conducted across sex. Internal consistency was evaluated with McDonald's omega. Additionally, construct validity was estimated across factors using the PHQ-9, GAD-7, AQ-J-10, and SSQ. EFA results showed that the JBFS-SF can be classified according to the expected five-factor structure, while three items had small loadings. Therefore, we dropped these three items and tested the reliability and validity of the 26-item version. CFA results found that a 26-item JBFS-FS has adequate structural validity (GFI = 0.907, AGFI = 0.886, CFI = 0.907, and RMSEA = 0.057). The omega of each factor was 0.74-0.85. Each JBFS-SF factor was specifically correlated with the PHQ-9, GAD-7, and SSQ. This research has shown that the JBFS-SF can be a clinically useful measure for assessing personality characteristics.

Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial.

BACKGROUND: Internet-based cognitive-behavioural therapy (iCBT) is effective for subthreshold depression. However, which skills provided in iCBT packages are more effective than others is unclear. Such knowledge can inform construction of more effective and efficient iCBT programmes. OBJECTIVE: To examine the efficacy of five components of iCBT for subthreshold depression. METHODS: We conducted an factorial trial using a smartphone app, randomly allocating presence or absence of five iCBT skills including self-monitoring, behavioural activation (BA), cognitive restructuring (CR), assertiveness training (AT) and problem-solving. Participants were university students with subthreshold depression. The primary outcome was the change on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 8. Secondary outcomes included changes in CBT skills. FINDINGS: We randomised a total of 1093 participants. In all groups, participants had a significant PHQ-9 reduction from baseline to week 8. Depression reduction was not significantly different between presence or absence of any component, with corresponding standardised mean differences (negative values indicate specific efficacy in favour of the component) ranging between -0.04 (95% CI -0.16 to 0.08) for BA and 0.06 (95% CI -0.06 to 0.18) for AT. Specific CBT skill improvements were noted for CR and AT but not for the others. CONCLUSIONS: There was significant reduction in depression for all participants regardless of the presence and absence of the examined iCBT components. CLINICAL IMPLICATION: We cannot yet make evidence-based recommendations for specific iCBT components. We suggest that future iCBT optimisation research should scrutinise the amount and structure of components to examine. TRIAL REGISTRATION NUMBER: UMINCTR-000031307.

Efficacy of Brief Intervention for Unhealthy Drug Use in Outpatient Medical Care: a Systematic Review and Meta-analysis.

BACKGROUND: The efficacy of brief intervention (BI) for unhealthy drug use in outpatient medical care has not been sufficiently substantiated through meta-analysis despite its ongoing global delivery. This study aims to determine the efficacy of BI for unhealthy drug use and the expected length of effects, and describe subgroup analyses by outpatient setting. METHODS: Trials comparing BI with usual care controls were retrieved through four databases up to January 13, 2021. Two reviewers independently screened, selected, and extracted data. Primary outcomes included drug use frequency (days used) and severity on validated scales at 4-8 months and were analyzed using random-effects model meta-analysis. RESULTS: In total, 20 studies with 9182 randomized patients were included. There was insufficient evidence to support the efficacy of BI for unhealthy drug use among all outpatient medical care settings for use frequency (SMD = -0.07, 95% CI = -0.17, 0.02, p = 0.12, I2 = 37%, high certainty of evidence) and severity (SMD = -0.27, 95% CI = -0.78, 0.24, p = 0.30, I2 = 98%, low certainty of evidence). However, post hoc subgroup analyses uncovered significant effects for use frequency by setting (interaction p = 0.02), with significant small effects only in emergency departments (SMD = -0.15, 95% CI = -0.25, -0.04, p < 0.01). Primary care, student health, women's health, and HIV primary care subgroups were nonsignificant. Primary care BI revealed nonsignificant greater average use in the treatment group compared to usual care. DISCUSSION: BI for unhealthy drug use lacks evidence of efficacy among all outpatient medical settings. However, small effects found in emergency departments may indicate incremental benefits for some patients. Clinical decisions for SBI or specialty treatment program referrals should be carefully considered accounting for these small effects in emergency departments. REGISTRATION: PROSPERO (CRD42020157733).

Initial treatment choices to achieve sustained response in major depression: a systematic review and network meta-analysis.

Major depression is often a relapsing disorder. It is therefore important to start its treatment with therapies that maximize the chance of not only getting the patients well but also keeping them well. We examined the associations between initial treatments and sustained response by conducting a network meta-analysis of randomized controlled trials (RCTs) in which adult patients with major depression were randomized to acute treatment with a psychotherapy (PSY), a protocolized antidepressant pharmacotherapy (PHA), their combination (COM), standard treatment in primary or secondary care (STD), or pill placebo, and were then followed up through a maintenance phase. By design, acute phase treatment could be continued into the maintenance phase, switched to another treatment or followed by discretionary treatment. We included 81 RCTs, with 13,722 participants. Sustained response was defined as responding to the acute treatment and subsequently having no depressive relapse through the maintenance phase (mean duration: 42.2±16.2 weeks, range 24-104 weeks). We extracted the data reported at the time point closest to 12 months. COM resulted in more sustained response than PHA, both when these treatments were continued into the maintenance phase (OR=2.52, 95% CI: 1.66-3.85) and when they were followed by discretionary treatment (OR=1.80, 95% CI: 1.21-2.67). The same applied to COM in comparison with STD (OR=2.90, 95% CI: 1.68-5.01 when COM was continued into the maintenance phase; OR=1.97, 95% CI: 1.51-2.58 when COM was followed by discretionary treatment). PSY also kept the patients well more often than PHA, both when these treatments were continued into the maintenance phase (OR=1.53, 95% CI: 1.00-2.35) and when they were followed by discretionary treatment (OR=1.66, 95% CI: 1.13-2.44). The same applied to PSY compared with STD (OR=1.76, 95% CI: 0.97-3.21 when PSY was continued into the maintenance phase; OR=1.83, 95% CI: 1.20-2.78 when PSY was followed by discretionary treatment). Given the average sustained response rate of 29% on STD, the advantages of PSY or COM over PHA or STD translated into risk differences ranging from 12 to 16 percentage points. We conclude that PSY and COM have more enduring effects than PHA. Clinical guidelines on the initial treatment choice for depression may need to be updated accordingly.

Development and validation of the Cognitive Behavioural Therapy Skills Scale among college students.

BACKGROUND: There are many different skill components used in cognitive behavioural therapy (CBT). However, there is currently no comprehensive way of measuring these skills in patients. OBJECTIVE: To develop a comprehensive and brief measure of five main CBT skills: self-monitoring, behavioural activation, cognitive restructuring, assertiveness training and problem-solving. METHODS: University students (N=847) who participated in a fully factorial randomised controlled trial of smartphone CBT were assessed with the CBT Skills Scale, the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) and the short form of the Japanese Big Five Scale. Structural validity was estimated with exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), and internal consistency evaluated with Cronbach's α coefficients. Construct validity was evaluated with the correlations between each factor of the CBT Skills Scale, the PHQ-9, the GAD-7 and the Big Five Scale. FINDINGS: The EFA supported a five-factor solution based on the original instruments assessing each CBT skill component. The CFA showed sufficient goodness-of-fit indices for the five-factor structure. The Cronbach's α of each factor was 0.75-0.81. Each CBT skills factor was specifically correlated to the PHQ-9, GAD-7, and the Big Five Scale. CONCLUSIONS: The CBT Skills Scale has a stable structural validity and internal consistency with a five-factor solution and appropriate content validity concerning the relationship with depression, anxiety and personality. CLINICAL IMPLICATIONS: The CBT Skills Scale will be potential predictor and effect modifier in studying the optimisation of CBT interventions. TRIAL REGISTRATION: CTR-000031307.

Efficacy of brief intervention for drug misuse in primary care facilities: systematic review and meta-analysis protocol.

INTRODUCTION: Drug misuse is associated with significant global morbidity, mortality, economic costs and social costs. Many primary care facilities have integrated drug misuse screening and brief intervention (BI) into their usual care delivery. However, the efficacy of BI for drug misuse in primary care has not been substantiated through meta-analysis. The aim of this systematic review and meta-analysis is to determine the efficacy of BI for drug misuse in primary care settings. METHODS AND ANALYSIS: We will include all randomised controlled trials comparing primary care-delivered BI for drug misuse with no intervention or minimal screening/assessment and usual care. Primary outcomes are (1) drug use frequency scores and (2) severity scores at intermediate follow-up (4-8 months). We will retrieve all studies through searches in CENTRAL, Embase, MEDLINE and PsycINFO until 31 May 2020. The reference list will be supplemented with searches in trial registries (eg, www.clinicaltrials.gov) and through relevant existing study reference lists identified in the literature. We will conduct a random-effect pairwise meta-analysis for primary and secondary outcomes. We will assess statistical heterogeneity though visual inspection of a forest plot and calculate I2 statistics. We will assess risk of bias using the Cochrane Risk of Bias Tool V.2 and evaluate the certainty of evidence through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Sensitivity analyses will account for studies with control group variations and studies with a high risk of bias. If heterogeneity is present, subgroup analyses will consider patient variables of age, sex/gender, race/ethnicity, per cent insured, baseline severity and primary drug misused. ETHICS AND DISSEMINATION: This study will use published aggregate data and will not require ethical approval. Findings will be disseminated in a peer-reviewed journal.