Effectiveness of multiple health behavior change interventions in reducing symptoms of anxiety in the adult population: A systematic review and meta-analysis of randomized controlled trials.

There is limited evidence regarding the effectiveness of preventive interventions for anxiety disorders. We aim to test the effectiveness of multiple health behavior change (MHBC) interventions in the reduction of symptoms of anxiety in the adult population. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted by searching the most relevant databases and registry platforms in the area. Reference lists of included articles and relevant systematic reviews and meta-analyses of MHBC interventions that examined anxiety or depression as outcomes were also manually searched. To identify RCTs that evaluated preventive interventions, we excluded studies in which the target population included only patients meeting the diagnostic criteria for anxiety disorders. To pool results, the standardized mean difference (SMD) was calculated using the random effects model. Sensitivity, subgroup and meta-regression analyses were performed. Forty-six RCTs were included in the qualitative synthesis, and 34 RCTs were included in the meta-analysis. Thirty RCTs were focused on promoting healthy diet and physical activity, whereas the other 16 studies also focused on smoking cessation. The pooled SMD was small (-0.183; 95% CI -0.276 to -0.091) but significant (p < 0.001). The effect became non-significant when only studies with a low risk of bias were included. There was substantial and significant heterogeneity between the studies. There is currently insufficient evidence regarding the effectiveness of MHBC interventions to reduce symptoms of anxiety in the adult population.

A multiple health behaviour change intervention to prevent depression: A randomized controlled trial.

OBJECTIVE: To examine the effectiveness of a 12-month MHBC intervention in the prevention of onset depression in primary health care (PHC). METHODS: Twenty-two PHC centres took part in the cluster-randomized controlled trial. Patients were randomized to receive either usual care or an MHBC intervention. The endpoints were onset of major depression and reduction of depressive symptoms in participants without baseline depression at a 12-month follow-up. RESULTS: 2531 patients agreed and were eligible to participate. At baseline, around 43% were smokers, 82% were non-adherent to the Mediterranean diet and 55% did not perform enough physical activity. The intervention group exhibited a greater positive change in two or more behaviours (OR 1.75 [95%CI: 1.17 to 2.62]; p = 0.006); any behaviour (OR 1.58 [95%CI: 1.13 to 2.20]; p = 0.007); and adherence to the Mediterranean diet (OR 1.94 [95%CI: 1.29 to 2.94]; p = 0.002), while this increase was not statistically significant for smoking and physical activity. The intervention was not effective in preventing major depression (OR 1.17; [95% CI 0.53 to 2.59)]; p = 0.690) or reducing depressive symptoms (Mean difference: 0.30; [95% CI -0.77 to 1.36]; p = 0.726) during follow-up. CONCLUSIONS: As compared to usual care, the MHBC intervention provided a non-significant reduction in the incidence of major depression. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03136211.

Utility of PHQ-2, PHQ-8 and PHQ-9 for detecting major depression in primary health care: a validation study in Spain.

BACKGROUND: Primary health care (PHC) professionals may play a crucial role in improving early diagnosis of depressive disorders. However, only 50% of cases are detected in PHC. The most widely used screening instrument for major depression is the Patient Health Questionnaire (PHQ), including the two-, eight- and nine-item versions. Surprisingly, there is neither enough evidence about the validity of PHQ in PHC patients in Spain nor indications about how to interpret the total scores. This study aimed to gather validity evidence to support the use of the three PHQ versions to screen for major depression in PHC in Spain. Additionally, the present study provided information for helping professionals to choose the best PHQ version according to the context. METHODS: The sample was composed of 2579 participants from 22 Spanish PHC centers participating in the EIRA-3 study. The reliability and validity of the three PHQ versions for Spanish PHC patients were assessed based on responses to the questionnaire. RESULTS: The PHQ-8 and PHQ-9 showed high internal consistency. The results obtained confirm the theoretically expected relationship between PHQ results and anxiety, social support and health-related QoL. A single-factor solution was confirmed. Regarding to the level of agreement with the CIDI interview (used as the criterion), our results indicate that the PHQ has a good discrimination power. The optimal cut-off values were: ⩾2 for PHQ-2, ⩾7 for PHQ-8 and ⩾8 for PHQ-9. CONCLUSIONS: PHQ is a good and valuable tool for detecting major depression in PHC patients in Spain.

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial.

BACKGROUND: This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45-75 years compared to usual care; and b) an implementation strategy. METHODS: A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. RESULTS: 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. CONCLUSIONS: Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

Multiple risk behaviour intervention to prevent depression in primary care.

BACKGROUND: Primary care is the ideal setting for promotion and prevention intervention. Multiple risk behaviour interventions present several advantages over single-risk lifestyle interventions. Multiple risk behaviour interventions could be easily implemented in primary care to prevent non-communicable disease and depression. AIM: To test the effectiveness of a multiple risk behaviour intervention to promote Mediterranean diet, physical activity, and/or smoking cessation in people attending Spanish primary health care with incidence of depression and symptoms of depression. METHOD: This was a secondary analysis of the EIRA study that aims to test the effectiveness of a multiple risk behaviour intervention to promote healthy lifestyles. Twenty-six primary care centres were randomised to receive multiple risk behaviour intervention or usual care. The multiple risk behaviour intervention included individual sessions, group sessions, communitarian activities, and SMS reception. Participants were followed for 10-14 months. The primary outcomes of this study were incidence of depression and reductions of depressive symptoms. RESULTS: Three thousand and sixty-seven participants were included. Females accounted for 45.13% and 93.88% were Spanish. Age varied between 45 and 75 years old. The effectiveness of the intervention will be calculated using the Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview ( CIDI) depression section. Linear and logistic regression will be used to create predictive models. CONCLUSION: Primary care is the most accessible service in the health system for patients. Hence primary care is the ideal setting for health education, promotion, and prevention interventions. This study will provide high-quality evidence about the effectiveness of multiple risk behaviour interventions over depression prevention.

Effectiveness of universal multiple-risk lifestyle interventions in reducing depressive symptoms: Systematic review and meta-analysis.

Though many studies have explored the association between single-risk lifestyle interventions and depression, unhealthy lifestyle factors often co-occur, with adults engaging in two or more risk behaviours. To date, little is known about the effectiveness of universal multiple-risk lifestyle interventions to reduce depressive symptoms. We conducted a SR/MA to assess the effectiveness of universal multiple-risk lifestyle interventions (by promoting a healthy diet, physical activity and/or smoking cessation) to reduce depressive symptoms in adults. We searched MEDLINE, Scopus, CENTRAL, PsycINFO, WOS, OpenGrey, the ICTRP and other sources from inception to 16 September 2019. We selected only randomized controlled trials, with no restrictions on language or setting. Our outcome was the reduction of depressive symptoms. We calculated the standardized mean difference using random-effect models. Sensitivity, sub-group and meta-regression analyses were performed. Of the 9386 abstracts reviewed, 311 were selected for full-text review. Of these, 23 RCTs met the inclusion criteria, including 7558 patients from four continents. Twenty RCTs provided valid data for inclusion in the meta-analysis. The pooled SMD was -0.184 (95% CI, -0.311 to -0.057; p = 0.005). We found no publication bias, but heterogeneity was substantial (I2 = 72%; 95% CI: 56% to 82%). The effectiveness disappeared when only studies with a low risk of bias were included. The quality of evidence according GRADE was low. Although a small preventive effect was found, the substantial heterogeneity and RCTs with lower risk of bias suggested no effectiveness of universal multiple-risk lifestyle interventions in reducing depressive symptoms in a varied adult population. Further evidence is required.

Peripheral immune aberrations in fibromyalgia: A systematic review, meta-analysis and meta-regression.

The objective was to identify immune alterations in patients with fibromyalgia syndrome (FMS) compared to healthy controls (HC) using meta-analysis and meta-regression. Six electronic databases were searched for suitable original articles investigating immune biomarkers in FMS in comparison to HC. We extracted outcomes and variables of interest, such as mean and SD of peripheral blood immune biomarkers, age or sex. A random-effects model with restricted maximum-likelihood estimator was used to compute effect sizes (standardized mean difference and 95% CI, Hedges' g) and meta-analysis, group meta-analysis and meta-regressions were conducted. Forty-three papers were included in this systematic review, of which 29 were suitable for meta-analysis. Interleukin (IL)-6 (g = 0.36 (0.09-0.63); I2 = 85.94; p = 0.01), IL-4 (g = 0.50 (0.03-0.98); I2 = 81.87; p = 0.04), and IL-17A (g = 0.53 (0.00-1.06); I2 = 87.15; p = 0.05), were significantly higher in FMS compared to HC while also combinations of cytokines into relevant phenotypes were significantly upregulated including M1 macrophage (g = 0.23 (0.03-0.43); I2 = 77.62; p = 0.02), and immune-regulatory (g = 0.40 (0.09-0.72); I2 = 84.81; p = 0.01) phenotypes. Heterogeneity levels were very high and subgroup and meta-regression analyses showed that many covariates explained part of the heterogeneity including medication washout, sex, time of blood sampling and exclusion of patients with major depressive disorder. In conclusion, FMS is accompanied by a disbalance between upregulated pro-inflammatory (M1 and Th-17) and immune-regulatory cytokines although effect sizes are small-to-moderate. Based on our results we provide specific methodological suggestions for future research, which should assess Th-1, Th-17, chemokines, and Th-2 phenotypes while controlling for possible confounding variables specified in this study.

Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials.

INTRODUCTION: Many studies have explored the impact of lifestyle interventions on depression. However, little is known about the effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression. Our objective is to assess the effectiveness of complex multiple-risk lifestyle interventions in reducing depressive symptoms in the adult population by the acquisition of at least two healthy habits-healthy diet, physical activity and/or smoking cessation. For such purpose, a systematic review and meta-analysis of randomised controlled trials will be conducted. METHOD AND ANALYSIS: MEDLINE (through Ovid and PubMed), Scopus, Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, OpenGrey Register (System for Information on Grey Literature in Europe) and the International Clinical Trials Registry Platform will be searched for relevant articles. Additionally, a supplementary manual search will be performed using lists of references, references to expert authors and other systematic reviews and/or meta-analyses. Study selection, data extraction (target habits, country, target populations, conditions and statistical data to name a few) and assessment of the risk of bias will be performed separately by two independent researchers. The primary outcome measure will be the reduction of depression symptoms, as measured by validated instruments. We will calculate pooled standardised mean differences and 95% CIs using random-effect models. Heterogeneity, sensitivity and publication bias will be assessed, and sub-group analysis will be performed. Heterogeneity will be explored by random-effects meta-regression analysis. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. The results of this systematic review and meta-analysis will be presented in relevant conferences and published in a peer-review journal. The findings of this study could have important clinical and scientific implications for the improvement of symptoms of depression. PROSPERO REGISTRATION NUMBER: CRD42018100253; Pre-results.

Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.

BACKGROUND: Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. METHODS: This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework. DISCUSSION: EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.

Predicting the onset of hazardous alcohol drinking in primary care: development and validation of a simple risk algorithm.

BACKGROUND: Little is known about the risk of progressing to hazardous alcohol use in abstinent or low-risk drinkers. AIM: To develop and validate a simple brief risk algorithm for the onset of hazardous alcohol drinking (HAD) over 12 months for use in primary care. DESIGN AND SETTING: Prospective cohort study in 32 health centres from six Spanish provinces, with evaluations at baseline, 6 months, and 12 months. METHOD: Forty-one risk factors were measured and multilevel logistic regression and inverse probability weighting were used to build the risk algorithm. The outcome was new occurrence of HAD during the study, as measured by the AUDIT. RESULTS: From the lists of 174 GPs, 3954 adult abstinent or low-risk drinkers were recruited. The 'predictAL-10' risk algorithm included just nine variables (10 questions): province, sex, age, cigarette consumption, perception of financial strain, having ever received treatment for an alcohol problem, childhood sexual abuse, AUDIT-C, and interaction AUDIT-C*Age. The c-index was 0.886 (95% CI = 0.854 to 0.918). The optimal cutoff had a sensitivity of 0.83 and specificity of 0.80. Excluding childhood sexual abuse from the model (the 'predictAL-9'), the c-index was 0.880 (95% CI = 0.847 to 0.913), sensitivity 0.79, and specificity 0.81. There was no statistically significant difference between the c-indexes of predictAL-10 and predictAL-9. CONCLUSION: The predictAL-10/9 is a simple and internally valid risk algorithm to predict the onset of hazardous alcohol drinking over 12 months in primary care attendees; it is a brief tool that is potentially useful for primary prevention of hazardous alcohol drinking.

Risk factors for the onset of panic and generalised anxiety disorders in the general adult population: a systematic review of cohort studies.

BACKGROUND: We aimed to assess available evidence on risk factors associated with the onset of panic disorder (PD) and/or generalised anxiety disorder (GAD) in cohort studies in the general adult population. METHODS: Systematic review using MEDLINE, PsycINFO and Embase. Search terms included panic disorder, generalised anxiety disorder, cohort studies and risk factors. RESULTS: We finally selected 21 studies, involving 163,366 persons with a median follow-up of 5 years. 1) Sociodemographic factors: PD was associated with age, female gender, and few economic resources. GAD was associated with age, non-Hispanics and Blacks, being divorced or widowed, and few economic resources. 2) Psychosocial factors: PD was associated with smoking and alcohol problems. GAD was associated with stressful life events in childhood and adulthood, and personality. 3) Physical and mental health factors: PD was associated with the number of physical diseases suffered and the joint hypermobility syndrome. PD was also associated with a parental history of mental disorders, as well as with other anxiety disorders and other mental health problems in the person affected. GAD was associated with a parental history of mental disorders, as well as with other anxiety disorders and other mental health problems in the person affected, plus already having received psychiatric care. LIMITATIONS: Few studies examined the same risk factors. CONCLUSIONS: Sociodemographic, psychosocial and mental-physical health risk factors were determinant for the onset of PD and GAD in the general adult population. These findings could be useful for developing preventive interventions in PD and GAD.

[Smoking prevalence and associated factors during pregnancy in Andalucía 2007-2012]. / Prevalencia de tabaquismo durante el embarazo y factores asociados en Andalucía 2007-2012 (*).

BACKGROUND: Smoking during pregnancy is the most important preventable perinatal health problem. The aim of this research is to determine smoking prevalence in pregnant women at different times of pregnancy in Andalucía, using biochemical validation methods and to explore factors associated with it. METHODS: Cross-sectional study. The study population was pregnant women followed in andalusian public health centers. A random sample of 40 health centers, stratified by number of pregnancies was collected, with 1813 pregnant enrolled in 3 independent samples (beginning and end of pregnancy, postpartum). The smoke exposure was measured by urinary cotinine, self-report and carbon monoxide in exhaled air. Control variables were socio-demographic, obstetric and related to smoking habit. A logistic regression was performed to explore factors associated with pregnancy smoking. RESULTS: The mean prevalence in the whole sample was 21.6%, which was lower at the end of pregnancy (15.6%) and postpartum (16.7%) than at the beginning (30.3%). Daily smokers fell from 56.3% before pregnancy to 14% at the end (according to selfreport). Most of the quitters gave up before pregnancy (21.8%) or when they noticed they were pregnant (23.6%). Deception rate was 19.6%, varying according to gestational age and the amount of tobacco consumed. Younger age (OR: 0.956, CI 0.92-0.99), be exposed to second hand smoke at home (OR: 3.48, CI 2.6 to 4.7), a higher level of consumption before pregnancy (6-10 OR 13.1 CI 3 to 56.9,> 10 OR 25.1 CI 5.8 to 109.6), greater gestational age at measurement (end OR: 0.5 CI: 0.4-0.8; immediate postpartum OR 0.4 CI 0.3-0.6) and lower educational level (no education and first grade compared to university OR: 1.98, CI 1.22 to 3.22) were identified as factors associated. CONCLUSION: Consumption variations with gestational age compel to indicate the time of measurement in prevalence studies. The profile of the pregnant smoker was being young, poorly educated, exposed to tobacco smoke at home and with a previous history of heavy smoking.