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).

Asymptomatic swallowing disorders may be present in individuals with laryngeal and hypopharyngeal cancer treated with chemo-radiotherapy.

PURPOSE: Patients with advanced laryngeal and hypopharyngeal cancer are often treated with chemo-radiotherapy to avoid total laryngectomy. Subclinical swallowing disorders could be present in these patients even though patients do not complain of any symptoms. We sought to evaluate the impact of chemoradiation on swallowing and quality of life. METHODS: We studied 21 patients undergoing chemo-radiotherapy for advanced laryngeal and hypopharyngeal cancer. All patients were tumor-free and none reported symptoms related to dysphagia during follow-up or showed altered routine screening tests (EAT-10) to detect it. Swallowing functions were assessed using volume-viscosity swallow test (V-VST) and fiberoptic endoscopic evaluation of swallowing (FEES). Quality of life was assessed with the EORT-H&N35, and SWAL-QOL scales. RESULTS: Frequent alterations in swallowing efficacy (100%) and safety (85.5%) were detected with V-VST and FEES. Quality-of-life scales showed a reduction in their scores between 12 and 17%, mainly in the areas of symptoms. CONCLUSION: Swallowing disorders are common after chemo-radiotherapy, even in patients who do not clinically manifest these disorders, contributing to a decrease in patients' quality of life. FEES and V-VST are useful procedures to detect asymptomatic swallowing disorders.

Exploring the structure of the GAD-7 scale in primary care patients with emotional disorders: A network analysis approach.

OBJECTIVE: Anxiety symptoms are one of the most frequent manifestations in people attending primary care, although how the symptoms are associated is unclear. This study aimed to establish the symptom structure of the Generalized Anxiety Disorder scale (GAD-7) using a novel network approach in combination with traditional analytical tools. METHODS: A sample of 1704 primary care patients with emotional disorders (i.e., anxiety, depression, and/or somatization) completed the GAD-7 to report their anxiety symptoms. We examined the GAD-7 structure using exploratory graph analysis (EGA) compared to exploratory factor analysis (EFA) and confirmatory factor analysis. RESULTS: The EFA results showed a one-factor solution, but EGA revealed a two-factor solution (cognitive-emotional and somatic). "Worrying too much" and "difficulty relaxing" were the most relevant symptoms. CONCLUSIONS: The results support the possible distinction between the somatic and cognitive-emotional components of the GAD-7, thus permitting more specific screening in primary care settings.

Transdiagnostic group cognitive behavioural therapy for emotional disorders in primary care: the results of the PsicAP randomized controlled trial.

BACKGROUND: Emotional disorders are highly prevalent in primary care. We aimed to determine whether a transdiagnostic psychological therapy plus treatment-as-usual (TAU) is more efficacious than TAU alone in primary care adult patients. METHODS: A randomized, two-arm, single-blind clinical trial was conducted in 22 primary care centres in Spain. A total of 1061 adult patients with emotional disorders were enrolled. The transdiagnostic protocol (n = 527) consisted of seven 90-min sessions (8-10 patients) delivered over a 12-14-week period. TAU (n = 534) consisted of regular consultations with a general practitioner. Primary outcome measures were self-reported symptoms of anxiety, depression, and somatizations. Secondary outcome measures were functioning and quality of life. Patients were assessed at baseline, post-treatment, and at 3, 6, and 12 months. Intention-to-treat and per-protocol analyses were performed. RESULTS: Post-treatment primary outcomes were significantly better in the transdiagnostic group compared to TAU (anxiety: p < 0.001; Morris's d = -0.65; depression: p < 0.001; d = -0.58, and somatic symptoms: p < 0.001; d = -0.40). These effects were sustained at the 12-month follow-up (anxiety: p < 0.001; d = -0.44; depression: p < 0.001; d = -0.36 and somatic symptoms: p < 0.001; d = -0.32). The transdiagnostic group also had significantly better outcomes on functioning (d = 0.16-0.33) and quality of life domains (d = 0.24-0.42), with sustained improvement at the 12-month follow-up in functioning (d = 0.25-0.39) and quality of life (d = 0.58-0.72). Reliable recovery rates showed large between-group effect sizes (d > 0.80) in favour of the transdiagnostic group after treatment and at the 12-month follow-up. CONCLUSIONS: Adding a brief transdiagnostic psychological intervention to TAU may significantly improve outcomes in emotional disorders treated in primary care. TRIAL REGISTRATION: isrctn.org identifier: ISRCTN58437086.

Moderators and predictors of treatment outcome in transdiagnostic group cognitive-behavioral therapy for primary care patients with emotional disorders.

OBJECTIVE: Transdiagnostic group cognitive behavior therapy (TD-GCBT) has shown to be efficacious in the treatment of emotional disorders in primary care. However, little is known about possible moderators or predictors of treatment outcome. We aimed to explore the potential predictors and moderators of outcome in a large multicentre randomized controlled trial comparing TD-GCBT plus treatment as usual (TAU) to TAU alone. METHOD: Putative demographic and baseline clinical variables were examined using the PROCESS macro as potential predictors/moderators of depressive and anxiety symptoms at posttreatment and 1-year follow-up. RESULTS: Analyses were based on a study completer sample of 1061 participants randomized to TD-CBT + TAU (n = 527) or TAU alone (n = 534), with 631 participants assessed at the posttreatment evaluation and 388 at the 1-year follow-up. Individuals working or with a partner among sociodemographic variables, and higher baseline comorbidities and more severity of symptoms among clinical variables obtained more benefits from adding TDCBT to TAU. Those taking medication before treatment obtained less benefits from the TD-GCBT than those without prescribed antidepressant medications, after controlling for baseline severity of symptoms. Overall, the moderating effect of clinical (but not sociodemographic) variables remained at 1-year follow-up. CONCLUSION: Findings support largely the generalization of the TD-GCBT for emotional disorders in primary care to a variety of sociodemographic and clinical groups. However, TD-GCBT seems to work to a greater extent for those individuals with a more severe clinical profile. Providing TD-GCBT before prescribing antidepressant medication and while people are still working may enhance the effects of adding this psychological treatment to TAU in primary care.

Brain-derived neurotrophic factor alleviates the oxidative stress induced by oxygen and glucose deprivation in an ex vivo brain slice model.

Brain-derived neurotrophic factor (BDNF) is considered as a putative therapeutic agent against stroke. Since BDNF role on oxidative stress is uncertain, we have studied this role in a rat brain slice ischemia model, which allows BDNF reaching the neural parenchyma. Hippocampal and cerebral cortex slices were subjected to oxygen and glucose deprivation (OGD) and then returned to normoxic conditions (reperfusion-like, RL). OGD/RL increased a number of parameters mirroring oxidative stress in the hippocampus that were reduced by the BDNF presence. BDNF also reduced the OGD/RL-increased activity in a number of antioxidant enzymes in the hippocampus but no effects were observed in the cerebral cortex. In general, we conclude that alleviation of oxidative stress by BDNF in OGD/RL-exposed slices relies on decreasing cPLA2 activity, rather than modifying antioxidant enzyme activities. Moreover, a role for the oxidative stress in the differential ischemic vulnerability of cerebral cortex and hippocampus is also supported.

Post-ischemic salubrinal administration reduces necroptosis in a rat model of global cerebral ischemia.

Ischemic stroke is one of the most important causes of death and disability worldwide. Subroutines underlying cell death after stroke are largely unknown despite their importance in the design of novel therapies for this pathology. Necroptosis, a recently described form of regulated cell death, has been related with inflammation and, in some models, with endoplasmic reticulum (ER) stress. We hypothesize that alleviation of ER stress following a salubrinal treatment will reduce the ischemic-dependent necroptosis. To probe the hypothesis, we measured, at 48 and 72 h after transient global cerebral ischemia in rat, in cerebral cortex and cornu ammonis 1, the main hallmarks of necroptosis: mRNA levels and phosphorylation of mixed lineage kinase domain like pseudokinase as well as receptor interacting serine/threonine protein kinase 3, along the years 2017-2018. Selective neuronal loss after 7 days of the ischemic insult, and other markers related with the inflammatory response were also measured. This study shows that necroptosis in cerebral cortex can be detected after 72 h of the insult and seems to be elicited before 48 h of reperfusion. The type of necroptosis here observed seems to be tumor necrosis factor receptor 1 independent. Necroptotic response is less evident in the cornu ammonis 1 hippocampal area than in cerebral cortex. The treatment with salubrinal administered 1 and 24 h after the ischemia, decreased the necroptotic marker levels and reduced the areas of selective neuronal loss, supporting the presence of ischemic-dependent necroptosis, and the notion that ER stress is involved in the necroptotic response. Open Science: This manuscript was awarded with the Open Materials Badge For more information see: https://cos.io/our-services/open-science-badges/.

Geographic and Temporal Variation of Distinct Intracellular Endosymbiont Strains of Wolbachia sp. in the Grasshopper Chorthippus parallelus: a Frequency-Dependent Mechanism?

Wolbachia is an intracellular endosymbiont that can produce a range of effects on host fitness, but the temporal dynamics of Wolbachia strains have rarely been experimentally evaluated. We compare interannual strain frequencies along a geographical region for understanding the forces that shape Wolbachia strain frequency in natural populations of its host, Chorthippus parallelus (Orthoptera, Acrididae). General linear models show that strain frequency changes significantly across geographical and temporal scales. Computer simulation allows to reject the compatibility of the observed patterns with either genetic drift or sampling errors. We use consecutive years to estimate total Wolbachia strain fitness. Our estimation of Wolbachia fitness is significant in most cases, within locality and between consecutive years, following a negatively frequency-dependent trend. Wolbachia spp. B and F strains show a temporal pattern of variation that is compatible with a negative frequency-dependent natural selection mechanism. Our results suggest that such a mechanism should be at least considered in future experimental and theoretical research strategies that attempt to understand Wolbachia biodiversity.

Chromosomal localization of Wolbachia inserts in the genomes of two subspecies of Chorthippus parallelus forming a Pyrenean hybrid zone.

Wolbachia are endosymbiotic bacteria of arthropods and nematodes that can manipulate the reproduction of various host organisms to facilitate their own maternal transmission. Moreover, Wolbachia's presence in host germ cells may contribute to the many cases of lateral gene transfer from Wolbachia to host genomes that have been described. A previous study in Chorthippus parallelus, a well-known orthopteroid forming a hybrid zone in the Pyrenees, identified Wolbachia sequences from two major supergroups in the genomes of infected and uninfected Chorthippus parallelus parallelus (Cpp) and Chorthippus parallelus erythropus (Cpe) subspecies. In this study, we map the Wolbachia genomic inserts to specific regions on the chromosomes of Cpp and Cpe by fluorescent in situ hybridization (FISH) using tyramides to increase the accuracy and detection of these insertions. Additionally, we consider some of the possible roles that these bacterial inserts play in the organization and function of the grasshopper genome, as well as how they can serve as markers for phylogenetic relationships of these organisms.

Utility of the PHQ-9 to identify major depressive disorder in adult patients in Spanish primary care centres.

BACKGROUND: The prevalence of major depressive disorder (MDD) in Spanish primary care (PC) centres is high. However, MDD is frequently underdiagnosed and consequently only some patients receive the appropriate treatment. The present study aims to determine the utility of the Patient Health Questionnaire-9 (PHQ-9) to identify MDD in a subset of PC patients participating in the large PsicAP study. METHODS: A total of 178 patients completed the full PHQ test, including the depression module (PHQ-9). Also, a Spanish version of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) was implemented by clinical psychologists that were blinded to the PHQ-9 results. We evaluated the psychometric properties of the PHQ-9 as a screening tool as compared to the SCID-I as a reference standard. RESULTS: The psychometric properties of the PHQ-9 for a cut-off value of 10 points were as follows: sensitivity, 0.95; specificity, 0.67. Using a cut-off of 12 points, the values were: sensitivity, 0.84; specificity, 0.78. Finally, using the diagnostic algorithm for depression (DSM-IV criteria), the sensitivity was 0.88 and the specificity 0.80. CONCLUSIONS: As a screening instrument, the PHQ-9 performed better with a cut-off value of 12 versus the standard cut-off of 10. However, the best psychometric properties were obtained with the DSM-IV diagnostic algorithm for depression. These findings indicate that the PHQ-9 is a highly satisfactory tool that can be used for screening MDD in the PC setting. TRIAL REGISTRATION: Current Controlled Trials ISRCTN58437086 . Registered 20 May 2013.

Solution structure of 6aJL2 and 6aJL2-R24G amyloidogenics light chain proteins.

AL amyloidosis is the most common amyloid systemic disease and it is characterized by the deposition of immunoglobulin light chain amyloid fibers in different organs, causing organ failure. The immunoglobulin light chain germinal line 6a has been observed to over-express in AL patients, moreover, it was observed that, out of these amyloidogenic proteins, 25% present a mutation of an Arg to Gly in position 24. In vitro studies have shown that this mutation produces proteins with a higher amyloid fiber propensity. It was proposed that this difference was due, in part, to the formation of a non-canonical structural element. In order to get a more detailed understanding of the structural and dynamic properties that govern the amyloid fibers formation process, we have determined the solution structure by NMR for the two constructs, showing that the difference in amyloid fibril formation is not due to sequence or structure.

CHD6, a cellular repressor of influenza virus replication, is degraded in human alveolar epithelial cells and mice lungs during infection.

The influenza virus polymerase associates to an important number of transcription-related proteins, including the largest subunit of the RNA polymerase II complex (RNAP II). Despite this association, degradation of the RNAP II takes place in the infected cells once viral transcription is completed. We have previously shown that the chromatin remodeler CHD6 protein interacts with the influenza virus polymerase complex, represses viral replication, and relocalizes to inactive chromatin during influenza virus infection. In this paper, we report that CHD6 acts as a negative modulator of the influenza virus polymerase activity and is also subjected to degradation through a process that includes the following characteristics: (i) the cellular proteasome is not implicated, (ii) the sole expression of the three viral polymerase subunits from its cloned cDNAs is sufficient to induce proteolysis, and (iii) degradation is also observed in vivo in lungs of infected mice and correlates with the increase of viral titers in the lungs. Collectively, the data indicate that CHD6 degradation is a general effect exerted by influenza A viruses and suggest that this viral repressor may play an important inhibitory role since degradation and accumulation into inactive chromatin occur during the infection.

Therapeutic Inertia in the Management of Type 2 Diabetes: A Narrative Review.

Adequate glycemic control is key to prevent morbi-mortality from type 2 diabetes (T2D). Despite the increasing availability of novel, effective, and safe medications for the treatment of T2D, and periodically updated guidelines on its management, the overall rate of glycemic goal attainment remains low (around 50%) and has not improved in the past decade. Therapeutic inertia (TI), defined as the failure to advance or de-intensify medical therapy when appropriate to do so, has been identified as a central contributor to the lack of progress in the rates of HbA1c goal attainment. The time to treatment intensification in patients not meeting glycemic goals has been estimated to be between 1 and 7 years from the time HbA1c exceeded 7%, and often, even when an intervention is carried out, it proves insufficient to achieve glycemic goals, which led to the concept of intensification inertia. Therefore, finding strategies to overcome all forms of TI in the management of T2D is a fundamental initiative, likely to have an enormous impact in health outcomes for people with T2D. There are several factors that have been described in the literature leading to TI, including clinician-related, patient-related, and healthcare system-related factors, which are discussed in this review. Likewise, several interventions addressing TI had been tested, most of them proving limited efficacy. Within the most effective interventions, there appear to be two common factors. First, they involve a team-based effort, including nurses, pharmacists, and diabetes educators. Second, they were built upon a framework based on results of qualitative studies conducted in the same context where they were later implemented, as will be discussed in this article. Given the complex nature of TI, it is crucial to use a research method that allows for an in-depth understanding of the phenomenon. Most of the literature on TI is focused on quantitatively describing its consequences; unfortunately, however, not many study groups have undertaken qualitative studies to deeply investigate the drivers of TI in their diverse contexts. This is particularly true in the United States, where there is an abundance of publications exploring the effects of different strategies to overcome TI in type 2 diabetes, but a severe shortage of qualitative studies aiming to truly understand the phenomenon.

Patterns of cognitive-emotional change after cognitive-behavioural treatment in emotional disorders: A 12-month longitudinal cluster analysis.

INTRODUCTION: The aim of this study was to use cluster analysis based on the trajectory of five cognitive-emotional processes (worry, rumination, metacognition, cognitive reappraisal and expressive suppression) over time to explore differences in clinical and performance variables in primary care patients with emotional symptoms. METHODS: We compared the effect of adding transdiagnostic cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) according to cluster membership and sought to determine the variables that predicted cluster membership. 732 participants completed scales about cognitive-emotional processes, anxiety and depressive symptoms, functioning, and quality of life (QoL) at baseline, posttreatment, and at 12 months. Longitudinal cluster analysis and logistic regression analyses were carried out. RESULTS: A two-cluster solution was chosen as the best fit, named as "less" or "more" improvement in cognitive-emotional processes. Individuals who achieved more improvement in cognitive-emotional processes showed lower emotional symptoms and better QoL and functioning at all three time points. TAU+TD-CBT, income level, QoL and anxiety symptoms were significant predictors of cluster membership. CONCLUSIONS: These results underscore the value of adding TD-CBT to reduce maladaptive cognitive-emotional regulation strategies. These findings highlight the importance of the processes of change in therapy and demonstrate the relevance of the patient's cognitive-emotional profile in improving treatment outcomes.

Effect of Reliable Recovery on Health Care Costs and Productivity Losses in Emotional Disorders.

Despite the high economic costs associated with emotional disorders, relatively few studies have examined the variation in costs according to whether the patient has achieved a reliable recovery. The aim of this study was to explore differences in health care costs and productivity losses between primary care patients from a previous randomized controlled trial (RCT)-PsicAP-with emotional symptoms who achieved a reliable recovery and those who did not after transdiagnostic cognitive-behavioral therapy (TD-CBT) plus treatment as usual (TAU) or TAU alone. Sociodemographic and cost data were obtained for 134 participants treated at five primary care centers in Madrid for the 12-month posttreatment period. Reliable recovery rates were higher in the patients who received TD-CBT + TAU versus TAU alone (66% vs. 34%, respectively; chi-square = 13.78, df = 1, p < .001). Patients who did not achieve reliable recovery incurred more costs, especially associated with general practitioner consultations (t = 3.01, df = 132, p = .003), use of emergency departments (t = 2.20, df = 132, p = .030), total health care costs (t = 2.01, df = 132, p = .040), and sick leaves (t = 1.97, df = 132, p = .048). These findings underscore the societal importance of achieving a reliable recovery in patients with emotional disorders, and further support the value of adding TD-CBT to TAU in the primary care setting.

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.

Variables Associated with Emotional Symptom Severity in Primary Care Patients: The Usefulness of a Logistic Regression Equation to Help Clinical Assessment and Treatment Decisions.

The aim of this study is to contribute to the evidence regarding variables related to emotional symptom severity and to use them to exemplify the potential usefulness of logistic regression for clinical assessment at primary care, where most of these disorders are treated. Cross-sectional data related to depression and anxiety symptoms, sociodemographic characteristics, quality of life (QoL), and emotion-regulation processes were collected from 1,704 primary care patients. Correlation and analysis of variance (ANOVA) tests were conducted to identify those variables associated with both depression and anxiety. Participants were then divided into severe and nonsevere emotional symptoms, and binomial logistic regression was used to identify the variables that contributed the most to classify the severity. The final adjusted model included psychological QoL (p < .001, odds ratio [OR] = .426, 95% CI [.318, .569]), negative metacognitions (p < .001, OR = 1.083, 95% CI [1.045, 1.122]), physical QoL (p < .001, OR = .870, 95% CI [.841, .900]), brooding rumination (p < .001, OR = 1.087, 95% CI [1.042, 1.133]), worry (p < .001, OR = 1.047, 95% CI [1.025, 1.070]), and employment status (p = .022, OR [.397, 2.039]) as independent variables, ρ2 = .326, area under the curve (AUC) = .857. Moreover, rumination and psychological QoL emerged as the best predictors to form a simplified equation to determine the emotional symptom severity (ρ2 = .259, AUC = .822). The use of statistical models like this could accelerate the assessment and treatment-decision process, depending less on the subjective point of view of clinicians and optimizing health care resources.

Neuroprotective effects of meloxicam on transient brain ischemia in rats: the two faces of anti-inflammatory treatments.

The inflammatory response plays an important role in neuroprotection and regeneration after ischemic insult. The use of non-steroidal anti-inflammatory drugs has been a matter of debate as to whether they have beneficial or detrimental effects. In this context, the effects of the anti-inflammatory agent meloxicam have been scarcely documented after stroke, but its ability to inhibit both cyclooxygenase isoforms (1 and 2) could be a promising strategy to modulate post-ischemic inflammation. This study analyzed the effect of meloxicam in a transient focal cerebral ischemia model in rats, measuring its neuroprotective effect after 48 hours and 7 days of reperfusion and the effects of the treatment on the glial scar and regenerative events such as the generation of new progenitors in the subventricular zone and axonal sprouting at the edge of the damaged area. We show that meloxicam's neuroprotective effects remained after 7 days of reperfusion even if its administration was restricted to the two first days after ischemia. Moreover, meloxicam treatment modulated glial scar reactivity, which matched with an increase in axonal sprouting. However, this treatment decreased the formation of neuronal progenitor cells. This study discusses the dual role of anti-inflammatory treatments after stroke and encourages the careful analysis of both the neuroprotective and the regenerative effects in preclinical studies.

Worry, rumination and negative metacognitive beliefs as moderators of outcomes of Transdiagnostic group cognitive-behavioural therapy in emotional disorders.

BACKGROUND: Despite the relevance of cognitive processes such as rumination, worry, negative metacognitive beliefs in emotional disorders, the existing literature about how these cognitive processes moderate the effect of treatment in treatment outcomes is limited. The aim of the present study was to explore the potential moderator effect of baseline cognitive processes-worry, rumination and negative metacognitive beliefs-on the relationship between treatment allocation (transdiagnostic cognitive-behavioural therapy -TD-CBT plus treatment as usual-TAU vs. TAU alone) and treatment outcomes (anxiety and depressive symptoms, quality of life [QoL], and functioning) in primary care patients with emotional disorders. METHODS: A total of 631 participants completed scales to evaluate worry, rumination, negative metacognitive beliefs, QoL, functioning, and anxiety and depressive symptoms. RESULTS: Worry and rumination acted as moderators on the effect of treatment for anxiety (b = -1.25, p = .003; b = -0.98, p = .048 respectively) and depressive symptoms (b = -1.21, p = .017; b = -1.34, p = .024 respectively). Individuals with higher baseline levels of worry and rumination obtained a greater reduction in emotional symptoms from the addition TD-CBT to TAU. Negative metacognitive beliefs were not a significant moderator of any treatment outcome. LIMITATIONS: The study assesses cognitive processes over a relatively short period of time and uses self-reported instruments. In addition, it only includes individuals with mild or moderate anxiety or depressive disorders, which limits generalization to other populations. CONCLUSIONS: These results underscore the generalization of the TD-CBT to individuals with emotional disorders in primary care with different cognitive profiles, especially those with high levels of worry and rumination.

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.