Cost-effectiveness and cost-utility evaluation of individual vs. group transdiagnostic psychological treatment for emotional disorders in primary care (PsicAP-Costs): a multicentre randomized controlled trial protocol.

BACKGROUND: Emotional disorders are common, and they have become more prevalent since the COVID-19 pandemic. Due to a high attendance burden at the specialized level, most emotional disorders in Spain are treated in primary care, where they are usually misdiagnosed and treated using psychotropic drugs. This contributes to perpetuate their illness and increase health care costs. Following the IAPT programme and the transdiagnostic approach, the PsicAP project developed a brief group transdiagnostic cognitive-behavioural therapy (tCBT) as a cost-effective alternative. However, it is not suitable for everyone; in some cases, one-on-one sessions may be more effective. The objective of the present study is to compare, in cost-benefit terms, group and individual tCBT with the treatment usually administered in Spanish primary care (TAU). METHODS: A randomized, controlled, multicentre, and single-blinded trial will be performed. Adults with mild to moderate emotional disorders will be recruited and placed in one of three arms: group tCBT, individual tCBT, or TAU. Medical data and outcomes regarding emotional symptoms, disability, quality of life, and emotion regulation biases will be collected at baseline, immediately after treatment, and 6 and 12 months later. The data will be used to calculate incremental cost-effectiveness and cost-utility ratios. DISCUSSION: This trial aims to contribute to clinical practice research. The involvement of psychologists in primary care and the implementation of a stepped-care model for mental disorders are recommended. Group therapy and a transdiagnostic approach may help optimize health system resources and unblock waiting lists so that people can spend less time experiencing mental health problems. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04847310; Protocols.io: bx2npqde. (April 19, 2021).

User involvement in the implementation of clinical guidelines for common mental health disorders: a review and compilation of strategies and resources.

BACKGROUND: There is now broad consensus regarding the importance of involving users in the process of implementing guidelines. Few studies, however, have addressed this issue, let alone the implementation of guidelines for common mental health disorders. The aim of this study is to compile and describe implementation strategies and resources related to common clinical mental health disorders targeted at service users. METHODS: The literature was reviewed and resources for the implementation of clinical guidelines were compiled using the PRISMA model. A mixed qualitative and quantitative analysis was performed based on a series of categories developed ad hoc. RESULTS: A total of 263 items were included in the preliminary analysis and 64 implementation resources aimed at users were analysed in depth. A wide variety of types, sources and formats were identified, including guides (40%), websites (29%), videos and leaflets, as well as instruments for the implementation of strategies regarding information and education (64%), self-care, or users' assessment of service quality. CONCLUSIONS: The results reveal the need to establish clear criteria for assessing the quality of implementation materials in general and standardising systems to classify user-targeted strategies. The compilation and description of key elements of strategies and resources for users can be of interest in designing materials and specific actions for this target audience, as well as improving the implementation of clinical guidelines.

Comparing psychological versus pharmacological treatment in emotional disorders: A network analysis.

Transdiagnostic group cognitive behavioural therapy (TD-GCBT) is more effective in improving symptoms and severity of emotional disorders (EDs) than treatment as usual (TAU; usually pharmacological treatment). However, there is little research that has examined the effects of these treatments on specific symptoms. This study used Network Intervention Analysis (NIA) to investigate the direct and differential effects of TD-GCBT + TAU and TAU on specific symptoms of anxiety and depression. Data are from a multicentre randomised clinical trial (N = 1061) comparing TD-GCBT + TAU versus TAU alone for EDs. The networks included items from the PHQ-9 (depression) and GAD-7 (anxiety) questionnaire and mixed graphical models were estimated at pre-treatment, post-treatment and 3-, 6- and 12-month follow-up. Results revealed that TD-GCBT + TAU was associated with direct effects, mainly on several anxiety symptoms and depressed mood after treatment. New direct effects on other depressive symptoms emerged during the follow-up period promoted by TD-GCBT compared to TAU. Our results suggest that the improvement of anxiety symptoms after treatment might precipitate a wave of changes that favour a decrease in depressive symptomatology. NIA is a methodology that can provide fine-grained insight into the likely pathways through which treatments exert their effects.

Cost-effectiveness of transdiagnostic group cognitive behavioural therapy versus group relaxation therapy for emotional disorders in primary care (PsicAP-Costs2): Protocol for a multicentre randomised controlled trial.

Several randomised controlled trials (RCT) have demonstrated the superiority of transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care. To date, however, no RCTs have been conducted to compare TD-CBT to another active intervention in this setting. Our aim is to conduct a single-blind RCT to compare group TD-CBT plus TAU to progressive muscle relaxation (PMR) plus TAU in adults (age 18 to 65 years) with a suspected emotional disorder. We expect that TD-CBT + TAU will be more cost-effective than TAU + PMR, and that these gains will be maintained at the 12-month follow-up. Seven therapy sessions (1.5 hours each) will be offered over a 24-week period. The study will be carried out at four primary care centres in Cantabria, Spain. The study will take a societal perspective. Psychological assessments will be made at three time points: baseline, post-treatment, and at 12-months. The following variables will be evaluated: clinical symptoms (anxiety, depression, and/or somatic); functioning; quality of life (QoL); cognitive-emotional factors (rumination, worry, attentional and interpretative biases, emotion regulation and meta-cognitive beliefs); and satisfaction with treatment. Data on health service use, medications, and sick days will be obtained from electronic medical records. Primary outcome measures will include: incremental cost-effectiveness ratios (ICER) and incremental cost-utility ratios (ICURs). Secondary outcome measures will include: clinical symptoms, QoL, functioning, and treatment satisfaction. Bootstrap sampling will be used to assess uncertainty of the results. Secondary moderation and mediation analyses will be conducted. Two questionnaires will be administered at sessions 1, 4, and 7 to assess therapeutic alliance and group satisfaction. If this trial is successful, widespread application of this cost-effective treatment could greatly improve access to psychological treatment for emotional disorders in the context of increasing demand for mental healthcare in primary care. Trial registration: ClinicalTrials.gov: Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP). NCT05314920.

Efficacy of a Combined Acceptance and Commitment Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients: Study Protocol for a Randomized Controlled Trial.

Psychological flexibility is a key concept of acceptation and commitment therapy (ACT). This factor has been linked with psychological wellbeing and associated factors, such as quality of life, in cancer patients. These and other positive results of acceptation and commitment therapy in cancer patients found in previous research could be enhanced by using mhealth tools. A three-arm randomized superiority clinical trial, with a pre-post-follow-up repeated measures intergroup design with a 1:1:1 allocation ratio is proposed. A hundred and twenty cancer patients will be randomly assigned to one of the following interventions: (1) face-to-face ACT + mobile application (app), (2) face-to-face ACT, and (3) Waitlist control group. The primary expected outcome is to observe significant improvements in psychological flexibility acceptance and action questionnaire- II (AAQ-II) in the face-to-face ACT + app group, after comparing baseline and post-treatment scores, and the scores will remain stable in the two assessment points, 3 and 6 months after the intervention. Secondary expected outcomes are significant increasing scores in quality of life (EORTC QLQ C-30) and post-traumatic-growth (PTGI-SF), and significant decreasing scores in anxiety and depression (HADS), insomnia (ISI) and fatigue (BFI) at the same assessment points. Also, it is expected that the scores of this group will be higher than the scores of the face-to-face ACT group and the waitlist control group. This study aims to assess the efficacy of a combined intervention (face-to face ACT + app) for psychological flexibility and associated symptoms in cancer patients. The results of this protocol may help to consider the use of acceptation and commitment therapy and mhealth applications in cancer settings as a valid therapeutic choice. Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT05126823].

Attitudes and collateral psychological effects of COVID-19 in pregnant women in Colombia.

OBJECTIVE: To assess clinical impact, psychological effects, and knowledge of pregnant women during the COVID-19 outbreak in seven cities in Colombia. Currently, there are uncertainty and concerns about the maternal and fetal consequences of SARS-CoV-2 infection during pregnancy. METHODS: A cross-sectional web survey was carried out including pregnant women in seven cities in Colombia. Women were evaluated during the mitigation phase of the SARS-CoV-2 pandemic between April 13 and May 18, 2020. The questions evaluated demographic, knowledge, psychological symptoms, and attitudes data regarding the COVID-19 pandemic. RESULTS: A total of 1021 patients were invited to participate, obtaining 946 valid surveys for analysis. The rate of psychological consequences of the pandemic was much larger than the number of patients clinically affected by the virus, with 50.4% of the entire cohort reporting symptoms of anxiety, 49.1% insomnia, and 25% reporting depressive symptoms. Poorly informed women were more likely to be younger, affiliated to the subsidized regime, and with lower levels of education. CONCLUSION: The knowledge of pregnant women about SARS-CoV-2 infection is far from reality and this seems to be associated with an indirect effect on the concern and psychological stress of pregnant women in Colombia.

Factorial invariance of a computerized version of the GAD-7 across various demographic groups and over time in primary care patients.

BACKGROUND: The Generalized Anxiety Disorder 7-item scale (GAD-7) is commonly used by clinicians and researchers to screen for anxiety disorders and to monitor anxiety symptoms in primary care. However, findings regarding its factor structure are mixed, with most studies reporting a best-fitting for a one-factor structure, whereas others indicate a two-factor model. To be valid for comparisons, the GAD-7 should measure the same latent construct with the same structure across groups and over time. We aimed to examine the best-fit factor structure model of the GAD-7 among primary care patients and to evaluate its measurement invariance. METHODS: A total of 1255 patients completed the computerized version of GAD-7 and a subsample of 238 cases was assessed at the 3-month follow-up. A confirmatory factor analysis (CFA) was performed and analyses of multiple-group invariance were also conducted to determine the extent to which the factor structure was comparable across various sociodemographic groups and over time. RESULTS: The results showed that both a one- and two-factor structure (representing somatic and cognitive-affective components) were invariant across sociodemographic groups and over time. The two-factor structure provided the best model fit. LIMITATIONS: Results cannot be generalized to all primary care patients, as only patients whose general practitioners consider them to suffer emotional disorders were included. CONCLUSIONS: Our study supports the reliability and validity of the one- and two-factor model of the GAD-7, both for screening purposes and for monitoring response to treatment.

Psychological Treatments for Mental Disorders in Children and Adolescents: A Review of the Evidence of Leading International Organizations.

In recent decades, the evidence on psychological treatments for children and adolescents has increased considerably. Several organizations have proposed different criteria to evaluate the evidence of psychological treatment in this age group. The aim of this study was to analyze evidence-based treatments drawn from RCTs, reviews, meta-analyses, guides and lists provided by four leading international organizations. The institutions reviewed were the National Institute for Health and Care Excellence, the Society of Clinical Child and Adolescent Psychology (Division 53) of the American Psychological Association, Cochrane Collaboration and the Australian Psychological Society in relation to mental disorders in children and adolescents. A total of 137 treatments were analyzed for 17 mental disorders and compared to determine the level of agreement among the organizations. The results indicate that, in most cases, there is little agreement among organizations and that there are several discrepancies within certain disorders. These results require reflection on the meaning attributed to evidence-based treatments with regard to psychological treatments in children and adolescents. The possible reasons for these differences could be explained by a combination of different issues: the procedures or committees may be biased, different studies were reviewed, different criteria are used by the organizations or the reviews of existing evidence were conducted in different time periods.

Clinical guideline implementation strategies for common mental health disorders.

INTRODUCTION: There has been a considerable proliferation of clinical guidelines recently, but their practical application is low, and organisations do not always implement their own ones. The aim of this study is to analyse and describe key elements of strategies and resources designed by the National Institute for Health and Care Excellence for the implementation of guidelines for common mental health disorders in adults, which are some of the most prevalent worldwide. METHOD: A systematic review was performed following PRISMA model. Resources, tools and implementation materials where included and categorised considering type, objectives, target and scope. RESULTS: A total of 212 elements were analysed, of which 33.5 and 24.5% are related to the implementation of generalized anxiety and depression guidelines, respectively. Applied tools designed to estimate costs and assess the feasibility of the setting up at local level are the most frequent type of resource. The study highlights the important variety of available materials, classified into 3 main strategies: tools targeting the professionals (30.6%), structural (26.4%), and organizational (24%). CONCLUSIONS: Developing guidelines is not enough; it is also necessary to promote their implementation in order to encourage their application. The resources and strategies described in this study may be potentially applicable to other contexts, and helpful to public health managers and professionals in the design of programmes and in the process of informed decision making to help increase access to efficient treatments.

El tratamiento de problemas psicológicos y de salud mental en atención primaria / The treatment of mental health and psychological problems in a primary care

Mental health concerns have significantly increased worldwide as they impact on individuals and families, society and public health costs, which are very common in the Primary Care sector. The aim of this study is to determine the general practitioner's perceptions in the prevalence of such disorders in Primary Health Care Centres (PHCC), and to explore the features of the treatments administered. Finally, we aim to evaluate the quality of the interventions and the level of implementation of key strategies and national and international recommendations. It is a single group ex post facto retrospective design. To carry out the research, we developed an ad-hoc self-administered survey including the World Health Organization Assessment Instrument for Mental Health Systems and official health documents indicators. This survey was applied to 77 general practitioners in PHCC in Cordoba, Spain. The most relevant results highlighted minor mental health problems (anxiety/depression and psychosocial problems) with a higher prevalence (79.6%) than formal mental health disorders (22.7%). The 43% of the consultations related to demands are directly or indirectly connected with mental disorders. The 23.4% of prescriptions in a typical day at work are psychotropics (sedatives/antidepressants). According to the general practitioners surveyed, 39% of patients treated with psychotropic drugs could solve their problems without taking them. With regard to the interventions, 80% of general practitioners did not work in teams or implement psychoeducational techniques and they did not make any interconsultations from the second level to deal with these problems. The 97.4% of them pointed out that the integration of psychologists in primary care centres would increase the quality of services. In this study, we find there is a contradiction between the treatments offered (based primarily on the administration of psychotropic drugs) and the recommendations made by national and international organizations. We consider that it is also necessary to revise the characteristics and quality of them and to reconsider professionals' profiles, competences and strategies.

Actualmente, la preocupación por los problemas de salud mental (PSM) ha aumentado considerablemente a escala mundial debido al impacto que representan a nivel individual, familiar y social y al coste que suponen para los sistemas de salud. Los objetivos de este estudio son conocer la percepción de los médicos de familia sobre la prevalencia de problemas psicológicos y de salud mental en Centros de Atención Primaria de la Salud (CAPS), explorar las características informadas sobre los tratamientos administrados y valorar el grado de implementación de estrategias y recomendaciones nacionales e internacionales. El estudio sigue un diseño ex post facto retrospectivo de grupo único. Se elaboró un autoinforme incluyendo indicadores del instrumento de evaluación WHO-AIMS de la OMS y de documentos sanitarios oficiales. Se aplicó a 77 médicos de los CAPS de la ciudad de Córdoba, España. Los resultados indican que los médicos perciben que los problemas "menores" de salud mental (principalmente síntomas de ansiedad/depresión y problemas psicosociales) tienen una prevalencia (79.6%) superior a los trastornos con diagnósticos formales (22.7%). El 43% de las consultas se relacionarían directa o indirectamente con PSM. Un 80% de los encuestados informa que no trabaja en equipo, no utiliza técnicas psicoeducativas y no realiza interconsulta con servicios especializados para el abordaje de estos casos. Refieren además, que 39% de los pacientes tratados con psicofármacos podrían resolver sus problemas sin hacer uso de ellos. Más de 50% considera no tener conocimientos suficientes para diagnosticar y/o tratar estos problemas. Y el 97.4% señala que incorporar psicólogos en los CAPS beneficiaría la prestación de servicios. El estudio pone de manifiesto la existencia de una importante brecha entre las características y calidad de los tratamientos ofrecidos y las recomendaciones de organismos oficiales. Consideramos que es necesario replantear las competencias de médicos y psicólogos y revisar los procesos y estrategias más idóneas para el abordaje de este tipo de problemas en atención primaria.