Protocol for an observational cohort study on psychological, addictive, lifestyle behavior and highly prevalent affective disorders in primary health care adults.

Background: Depression and anxious symptoms are prevalent in the general population, and their onset and persistence may be linked to biological and psychosocial factors, many of which are lifestyle-related. The way we manage our care, physical and emotional health and/or discomfort is highly influenced by our own abilities, skills and attitudes despite life's circumstances. The main aim of this protocol to analyze the relationship between psychological constructs (self-efficacy, activation, health literacy, resilience, personality traits, sense of coherence, self-esteem), and the presence of affective-emotional problems (anxiety, depression) and addictions in primary health care. Methods: This is a protocol of a prospective longitudinal cohort study including people of 35-74 years old of Aragon primary health care centers (Spain). Three evaluations will be conducted: baseline evaluation, and follow-up assessments five and ten years after recruitment. The primary outcomes will be severity of depression, severity of anxiety, and addictive behaviors. A detailed set of secondary outcomes will be assessed across all three assessments. This will include psychosocial or personal factors on health behavior, social support, lifestyle patterns, quality of life, the use of health and social resources, and chronic comorbid pathology. Discussion: The analysis of the impact of psychological constructs and lifestyles on the mental health of people and communities will provide evidence that will make it possible to better address and prevent these prevalent problems and address their improvement from a more global and holistic perspective. The evaluation of psychological constructs should be incorporated into health services to improve people's ability their self-care, the level of knowledge of managing their disease and their physical, mental and social health. Clinical trial registration: https://www.isrctn.com/, identifier ISRCTN12820058.

Effectiveness of four deconstructive meditative practices on well-being and self-deconstruction: study protocol for an exploratory randomized controlled trial.

INTRODUCTION: The efficacy of interventions based on mindfulness and compassion has been demonstrated in both clinical and general population, and in different social contexts. These interventions include so-called attentional and constructive meditation practices, respectively. However, there is a third group, known as deconstructive meditation practices, which has not been scientifically studied. Deconstructive practices aim to undo maladaptive cognitive patterns and generate knowledge about internal models of oneself, others and the world. Although there are theoretical and philosophical studies on the origin of addiction to the self or on the mechanisms of action associated with the deconstruction of the self, there are no randomized controlled trials evaluating these techniques in either a healthy population or clinical samples. This study aims to evaluate the effect of three deconstructive techniques by comparing them to mindfulness in the general population. METHODS AND ANALYSIS: A randomized controlled clinical trial will be conducted with about 240 participants allocated to four groups: (a) mindful breathing, (b) prostrations, according to Tibetan Buddhist tradition; (c) the Koan Mu, according to Zen Buddhist tradition; and (d) the mirror exercise, according to Toltec tradition. The primary outcome will be the qualities of the non-dual experience and spiritual awakening, measured by the Nondual Embodiment Thematic Inventory, assessed at pre- and post-treatment and at 3- and 6-month follow-ups. Other outcomes will be mindfulness, happiness, compassion, affectivity and altered state of consciousness. Quantitative data will be compared using mixed-effects linear regression models, and qualitative data will be analysed through thematic analysis and using the constant comparative method from grounded theory. ETHICS AND DISSEMINATION: Approval was obtained from the Research Ethics Committee of Aragon, Spain. The results will be submitted to peer-reviewed specialized journals, and brief reports will be sent to participants on request. TRIAL REGISTRATION: ClinicalTrials.gov NCT05317754. Registered on August 2,2022.

Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) for Shoulder Mobility Improvement in Women with Upper Limb Lymphedema Secondary to Breast Cancer: A Multicenter Controlled Clinical Trial.

BACKGROUND: Lymphedema, secondary to breast cancer (BCRL), is the abnormal accumulation of protein-rich fluid in the interstitium caused by a malfunction of the lymphatic system. It causes swelling, deficiencies in upper limb functions and structures, sensory pain and emotional alterations, which have a chronic course and affect the upper limb's functionality. This study aims to verify the efficacy and efficiency in the upper limb´s functionality of a protocolized experimental approach based on occupational therapy, TAPA (activity-oriented proprioceptive antiedema therapy), in the rehabilitation of BCRL in stages I and II, comparing it with the conservative treatment considered as the standard, complex decongestive therapy (CDT), through a multicenter randomized clinical trial. METHODS: a randomized and prospective clinical trial was conducted with experimental and control groups. Women diagnosed with BCRL belonging to institutions in Córdoba and Aragon (Spain) participated. Sociodemographic variables and those related to the functionality of the affected upper limb were evaluated before and after the intervention. RESULTS: The results showed statistically significant differences in the analysis of covariance performed for the variable joint balance of the shoulder´s external rotation (p = 0.045) that could be attributed to the intervention performed; however, the effect size was minimal (η2 ≤ 0.080). In the rest of the variables, no significant differences were found. CONCLUSIONS: TAPA may be an alternative to the conservative treatment of women with BCRL. It was shown to be just as effective for volume reduction and activity performance as CDT but more effective in improving external rotation in shoulder joint balance.

Mindfulness-Based Program for Anxiety and Depression Treatment in Healthcare Professionals: A Pilot Randomized Controlled Trial.

In primary health care, the work environment can cause high levels of anxiety and depression, triggering relevant expert and individual change. Mindfulness-Based Stress Reduction (MBSR) programs reduce signs of anxiety and depression. The purpose of this sub-analysis of the total project, was to equate the effectiveness of the standard MBSR curriculum with the abbreviated version in minimizing anxiety and depression. This randomized controlled clinical trial enrolled 112 mentors and resident specialists from Family and Community Medicine and Nurses (FCMN), distributed across six teaching units (TU) of the Spanish National Health System (SNHS). Experimental group participants received a MBRS training (abbreviated/standard). Depression and anxiety levels were measured with the Goldberg Anxiety and Depression Scale (GADS) at three different time periods during the analysis: before (pre-test) and after (post-test) participation, as well as 3 months after the completion of intervention. Taking into account the pre-test scores as the covariate, an adjusted analysis of covariance (ANCOVA) showed significant depletion in anxiety and depression in general (F (2.91) = 4.488; p = 0.014; η2 = 0.090) and depression in particular (F (2, 91) = 6.653; p = 0.002; η2 = 0.128 at the post-test visit, maintaining their effects for 3 months (F (2.79) = 3.031; p = 0.050; η2 = 0.071-F (2.79) = 2.874; p = 0.049; η2 = 0.068, respectively), which is associated with the use of a standard training program. The abbreviated training program did not have a significant effect on the level of anxiety and depression. The standard MBSR training program had a positive effect on anxiety and depression and promotes long-lasting effects in tutors and resident practitioners. New research is needed to demonstrate the effectiveness of abbreviated versions of training programs.

Mindfulness in primary care healthcare and teaching professionals and its relationship with stress at work: a multicentric cross-sectional study.

BACKGROUND: Work stress is a common problem among the health personnel of the Spanish National Health System. The objective of this paper is to assess the state of mindfulness among Spanish primary care providers and to evaluate its potential relationship with work stress and basic labor and sociodemographic characteristics. METHODS: Cross-sectional, multi-centric study. Primary care nurses, teachers, teaching collaborators and residents assigned to six Spanish Family Medicine/Family and Community Care Departments were invited to participate (n = 475). A template was designed in Google Forms, including sociodemographic and work-related variables. The state of mindfulness was measured with the Five Facet Mindfulness Questionnaire (FFMQ), while work-related stress was measured using an ordinal scale ranging from 0 to 10 points. Descriptive and inferential statistical analyses were carried out, as well as bivariate and multivariate statistics. RESULTS: The mean age of participants was 40,14 ± 13.12 (range:23-65 years); 66.9% were women, 42.5% internal medicine residents, 29.3% family physicians, and 20.2% nurses. More than half (54.5%) knew about mindfulness, with 24.0% have received training on it, and 22.5% were usual practitioners. The average level of mindfulness was 127.18 ± 15.45 (range: 89-177). The average score of stress at work was 6.00 ± 2.44; 49.9% (range: 0-10). 49.9% of participants scored 7 or more on the stress at work scale. There was an inverse correlation between the levels of mindfulness (FFMQ total score) and work-related stress (Spearman's r = - 0.155, p = 0.003). Significant relationships between the mindfulness practice and the level of mindfulness (F = 29.80, p < 0.001), as well as between the mindfulness practice and the level of work-related stress (F = 9.68, p = 0.042), were also found. CONCLUSIONS: Levels of mindfulness in primary care health providers were in line with those levels observed in other groups of health professionals. Half of all of the primary care providers suffered from a high degree of stress. Although weak, inverse relationships were observed between levels of mindfulness and stress at work, with lower values of stress at work among those who practiced mindfulness. TRIAL REGISTRATION: NCT03629457 .

Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial.

BACKGROUND: Breast cancer (BC) is a major public health issue. More than one out of five women treated for breast cancer will develop lymphedema in an upper extremity. Current evidence advocates transdisciplinary oncological rehabilitation. Therefore, research in this area is necessary since limited consensus having been reached with regard to the basic essential components of this rehabilitation. Consensus has, however, been reached on the use of decongestive lymphedema therapy (DLT), but due to a lack of tests, the necessary dosages are unknown and its level is moderately strong. This study attempts to verify both the efficacy of activity-oriented proprioceptive antiedema therapy (TAPA), as compared to conventional treatments such as DLT or Complex Physical Therapy (CPT), as well as its efficiency in terms of cost-effectiveness, for patients affected by breast cancer-related arm lymphedema. METHODS: Controlled, randomized clinical trial with dual stratification, two parallel arms, longitudinal and single blind. 64 women with breast cancer-related arm lymphedema will take part in the study. The experimental group intervention will be the same for stage I and II, and will consist of neuro-dynamic exercises oriented to the activity, proprioceptive neuromuscular facilitation activities and proprioceptive anti-edema bandaging. The control group intervention, depending on the stage, will consist of preventive measures, skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II). RESULTS: Sociodemographic and clinical variables will be collected for the measurement of edema volume and ADL performance. Statistical analysis will be performed on intent to treat. DISCUSSION: It has been recommended that patient training be added to DLT, as well as a re-designing of patient lifestyles and the promotion of health-related aspects. In addition, clinical trials should be undertaken to assess neural mobilization techniques and proprioceptive neuromuscular facilitation should be included in the therapy. Cohesive bandaging will also be performed as an early form of pressotherapy. The proposed study combines all of these aspects in order to increased comfort and promote the participation of individuals with lymphedema in everyday situations. LIMITATIONS: The authors have proposed the assessment of the experimental treatment for stages I and II. One possible limitation is the lack of awareness of whether or not this treatment would be effective for other stages as well as the concern for proper hand cleansing during use of bandages, given the current COVID-19 pandemic situation. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov ( NCT03762044 ). Date of registration: 23 November 2018. Prospectively Registered.

Variables Associated With Negotiation Effectiveness: The Role of Mindfulness.

Negotiation is the main mean of conflict resolution. Despite its capital importance, little is known about influencing variables or effective interventions. Mindfulness has shown to improve subjects' performance in different settings but until now, no study has shown its impact in negotiation. The aim of this study is to analyze which variables are associated with effectiveness and to determine if meditators are more effective in negotiation. A cross-sectional descriptive study was carried out. The study variables were: socio-demographic variables, negotiation effectiveness (Negotiation Effectiveness Questionnaire), mindfulness (Five Facets of Mindfulness Questionnaire), emotional intelligence (Trait Meta-Mood Scale Questionnaire), personality (NEO-FFI personality inventory), motivation (McClelland Questionnaire), and negotiation style (Rahim Organizational Conflict Inventory-II). A correlational study and a multivariate model were developed. Negotiation effectiveness was associated with age, mindfulness, emotional intelligence, extraversion, openness, conscientiousness, achievement motivation, integrating, dominating, and compromising negotiation styles and inversely correlated toward neuroticism. The effectiveness of the negotiation is explained by the variables clarity, age, conscientiousness, dominating, and compromising style. Meditators were found to be more effective than non-meditators.

Validation of Five Facets Mindfulness Questionnaire - Short form, in Spanish, general health care services patients sample: Prediction of depression through mindfulness scale.

The validation of Five Facets Mindfulness Questionnaire (FFMQ)-short version was performed in a general population of a city in a region of Galicia (Spain), the sample was composed of randomly selected Spanish Health Care patients (N = 845). The results on the goodness of fit of the non-hierarchical, five-dimensional factorial model met the criteria for good and acceptable model adjustment (after eliminating item 18 and despite the correlations detected among the errors included in the model), explaining a 55.5%.of the variance. As the second objective has been analysed the association between the scores obtained in the different facets of the FFMQ-SF and the risk of suffering an episode of depression. (The Odd Ratio, the Hosmer-Lemeshow test and the ROC curve were calculated.) Participants who were currently suffering from an episode of depression were more likely to have low scores in "describing" facet of Mindfulness (adjusted OR = 1.58, 95% CI = 1.04-2.40, linear trend: χ2 = 3.74, df = 1, p = 0.053) as well as low scores on "acting with awareness" (adjusted OR = 2.19, 95% CI = 1.461-3.30, linear trend: χ2 = 9.52, df = 1; = 0.002) and "non judging" (adjusted OR = 2.05, 95% CI = 1.36-3.09, linear trend: χ2 = 143.21, df = 1; p <0.001). Participants with a previous episode of depression were more likely to have low scores on the subscale "acting with awareness" (adjusted OR = 2.37, 95% CI = 1.43-3.93, linear trend: χ2 = 9.62, df = 1, p = 0.002) and "non-reactivity" (adjusted OR = 2.14, 95% CI = 1.28-3.56, linear trend: χ2 = 8.30; df = 1; p = 0.004. Questionnaire FFMQ-SF is an adequate questionnaire for the evaluation of mindfulness in non-clinical multi- occupational population.

Controlled clinical trial comparing the effectiveness of a mindfulness and self-compassion 4-session programme versus an 8-session programme to reduce work stress and burnout in family and community medicine physicians and nurses: MINDUUDD study protocol.

BACKGROUND: Health personnel are susceptible to high levels of work stress and burnout due to the psychological and emotional demands of their work, as well as to other aspects related to the organisation of that work. This paper describes the rationale and design of the MINDUUDD study, the aim of which is to evaluate the effectiveness of a mindfulness and self-compassion 4-session programme versus the standard 8-session programme to reduce work stress and burnout in Family and Community Medicine and Nursing tutors and residents. METHODS: The MINDUDD study is a multicentre cluster randomised controlled trial with three parallel arms. Six Teaching Units will be randomised to one of the three study groups: 1) Experimental Group-8 (EG8); 2) Experimental Group-4 (EG4) Control group (CG). At least 132 subjects will participate (66 tutors/66 residents), 44 in the EG8, 44 in the EG4, and 44 in the CG. Interventions will be based on the Mindfulness-Based Stress Reduction (MBSR) program, including some self-compassion practices of the Mindful Self-Compassion (MSC) programme. The EG8 intervention will be implemented during 8 weekly face-to-face sessions of 2.5 h each, while the EG4 intervention will consist of 4 sessions of 2.5 h each. The participants will have to practice at home for 30 min/day in the EG8 and 15 min/day in the EG4. The Five Facet Mindfulness Questionnaire (FFMQ), Self-Compassion Scale (SCS), Perceived Stress Questionnaire (PSQ), Maslach Burnout Inventory (MBI), Jefferson Scale of Physician Empathy (JSPE), and Goldberg Anxiety-Depression Scale (GADS) will be administered. Measurements will be taken at baseline, at the end of the programs, and at three months after completion. The effect of the interventions will be evaluated by bivariate and multivariate analyses (Multiple Linear Regression). DISCUSSION: If the abbreviated mindfulness programme is at least as effective as the standard program, its incorporation into the curriculum and training plans will be easier and more appropriate. It will also be more easily applied and accepted by primary care professionals because of the reduced resources and means required for its implementation, and it may also extend beyond care settings to academic and teaching environments as well. TRIAL REGISTRATION: The study has been registered at ClinicalTrials.gov ( NCT03629457 ; date of registration: 13.08.2018).

[Equity and patient autonomy in the care strategies for patients with chronic disease of health services in Spain]. / Equidad y autonomía del paciente en las estrategias de atención a personas con enfermedades crónicas en los servicios de salud de España.

OBJECTIVE: To examine the chronic care models of the different Spanish health services and to discuss the ethical questions derived from implementing some of their components. METHOD: Narrative review of care strategies and programmes for chronic patients in the different Autonomous Communities, searching in official health departments' web pages, using the terms "Programmes", "Strategies", "Chronic patients", and "Chronicity". RESULTS: 15 programmes were found. Most of them include all components of the chronic care model, "decision-making support" being under-represented. The main conflicts in the autonomy of patients arise from the use of big data to stratify the population and from telemonitoring. The stratification of population does not consider the social factors that accompany the disease. CONCLUSIONS: Chronic care strategies should consider the autonomy and privacy of patients in the use of clinical data and telemonitoring. In order to be equitable, they would have to provide an integrated health care system, incorporating measures to reduce the inequalities due to the social determinants that accompany the disease.

Relation of the Psychological Constructs of Resilience, Mindfulness, and Self-Compassion on the Perception of Physical and Mental Health.

PURPOSE: Health factors that enhance an individual's ability to perceive and maintain health and well-being are referred to as "health assets". Of these assets, resilience, mindfulness and self-compassion are considered to be of special importance. The objective of this study was to analyze the association between these psychological constructs on the perception of physical and mental health in a general population. PATIENTS AND METHODS: A descriptive and analytical cross-sectional study was conducted with 845 participating subjects. The outcome variable was the individual´s perception of physical and mental health, measured using the SF-36 questionnaire. The independent variables were: sociodemographic variables, medical information, physical activity performance (using the International Physical Activity Questionnaire), tobacco and alcohol consumption, anxiety and/or depression (using the Goldberg Anxiety and Depression Scale), resilience (using the Connor-Davidson Resilience Scale), mindfulness (with the Five Facets of Mindfulness Questionnaire Short Form) and self-compassion (using the Self-compassion scale-short form). A correlation analysis, simple linear regression and multiple linear regression were carried out, controlling for the influence of the distinct independent variables. RESULTS: The constructs of resilience, mindfulness and self-compassion are significant, in the perception of both physical and mental health. Other factors appearing in the multiple regression are gender, age, educational level, physical activity and tobacco consumption, in a positive or negative sense. CONCLUSION: The study of these associations is fundamental for the understanding of underlying regulation processes of healthy lifestyles in the general population.

Factors related to the development of health-promoting community activities in Spanish primary healthcare: two case-control studies.

OBJECTIVE: Spanish primary healthcare teams have the responsibility of performing health-promoting community activities (CAs), although such activities are not widespread. Our aim was to identify the factors related to participation in those activities. DESIGN: Two case-control studies. SETTING: Performed in primary care of five Spanish regions. SUBJECTS: In the first study, cases were teams that performed health-promoting CAs and controls were those that did not. In the second study (on case teams from the first study), cases were professionals who developed these activities and controls were those who did not. MAIN OUTCOME MEASURES: Team, professional and community characteristics collected through questionnaires (team managers/professionals) and from secondary sources. RESULTS: The first study examined 203 teams (103 cases, 100 controls). Adjusted factors associated with performing CAs were percentage of nurses (OR 1.07, 95% CI 1.01 to 1.14), community socioeconomic status (higher vs lower OR 2.16, 95% CI 1.18 to 3.95) and performing undergraduate training (OR 0.44, 95% CI 0.21 to 0.93). In the second study, 597 professionals responded (254 cases, 343 controls). Adjusted factors were professional classification (physicians do fewer activities than nurses and social workers do more), training in CAs (OR 1.9, 95% CI 1.2 to 3.1), team support (OR 2.9, 95% CI 1.5 to 5.7), seniority (OR 1.06, 95% CI 1.03 to 1.09), nursing tutor (OR 2.0, 95% CI 1.1 to 3.5), motivation (OR 3.7, 95% CI 1.8 to 7.5), collaboration with non-governmental organisations (OR 1.9, 95% CI 1.2 to 3.1) and participation in neighbourhood activities (OR 3.1, 95% CI 1.9 to 5.1). CONCLUSIONS: Professional personal characteristics, such as social sensitivity, profession, to feel team support or motivation, have influence in performing health-promoting CAs. In contrast to the opinion expressed by many professionals, workload is not related to performance of health-promoting CAs.

Contribution of Dry Needling to Individualized Physical Therapy Treatment of Shoulder Pain: A Randomized Clinical Trial.

Study Design Multicenter, parallel randomized clinical trial. Background Myofascial trigger points (MTrPs) are implicated in shoulder pain and functional limitations. An intervention intended to treat MTrPs is dry needling. Objectives To investigate the effectiveness of dry needling in addition to evidence-based personalized physical therapy treatment in the treatment of shoulder pain. Methods One hundred twenty patients with nonspecific shoulder pain were randomly allocated into 2 parallel groups: (1) personalized, evidencebased physical therapy treatment; and (2) trigger point dry needling in addition to personalized, evidence-based physical therapy treatment. Patients were assessed at baseline, posttreatment, and 3-month follow-up. The primary outcome measure was pain assessed by a visual analog scale at 3 months, and secondary variables were joint range-of-motion limitations, Constant-Murley score for pain and function, and number of active MTrPs. Clinical efficacy was assessed using intention-to-treat analysis. Results Of the 120 enrolled patients, 63 were randomly assigned to the control group and 57 to the intervention group. There were no significant differences in outcome between the 2 treatment groups. Both groups showed improvement over time. Conclusion Dry needling did not offer benefits in addition to personalized, evidencebased physical therapy treatment for patients with nonspecific shoulder pain. Level of Evidence Therapy, level 1b. Registered February 11, 2009 at www.isrctn.com (ISRCTN30907460). J Orthop Sports Phys Ther 2017;47(1):11-20. Epub 9 Dec 2016. doi:10.2519/jospt.2017.6698.