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.

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.

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.

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).

Improving Access to Psychological Therapies in Spain: From IAPT to PsicAP.

BACKGROUND: Anxiety and depression are very prevalent in primary care, with high rates of chronic cases, comorbidity and lost quality of life, along with huge economic costs. The Improving Access to Psychological Therapies (IAPT) project, launched in the United Kingdom in 2007, has become an international benchmark for the treatment of common mental disorders. In Spain, Psicofundación developed the PsicAP clinical trial, following the precedent set by the IAPT. METHOD: This study reviews and compares and contrasts the methods, results, and contributions of the IAPT and PsicAP. RESULTS: The IAPT is a project for the pragmatic implementation of evidence-based psychological therapies in primary care. PsicAP is a randomized clinical trial whose results demonstrated that adding a psychological treatment (seven group sessions of transdiagnostic cognitive-behavioural therapy) to treatment-as-usual (TAU) for anxiety and depression in the primary care setting was more effective and cost-effective than TAU alone. The therapeutic gains and the cost-effectiveness were maintained at a 12 months follow-up. Moreover, the percentage of reliably recovered patients was comparable to the numbers from the IAPT. CONCLUSIONS: This brief psychological treatment should be implemented in the Spanish public health system, similar to the precedent set by the IAPT initiative.

Disability and perceived stress in primary care patients with major depression.

BACKGROUND: Major depressive disorder (MDD) is highly prevalent in the Spanish primary care (PC) setting and the leading cause of disability in Spain. The aim of this study was to evaluate several key psychometric properties of the Sheehan Disability Scale (SDS) in patients with or without MDD and varying degrees of symptom severity using the Patient Health Questionnaire-9 (PHQ-9). METHOD: A total of 1,704 PC patients participating in the PsicAP clinical trial completed the SDS and PHQ-9. We evaluated the factor structure, measurement invariance across gender, internal consistency, and the discriminative and predictive validity. RESULTS: Confirmatory factor analyses revealed a unifactorial model of the SDS containing 4 items (SDS-4) with the best model fit (CFI: .99; GFI: .99; TLI: 96; RMSEA: .10). This model contained the three life domain items (work, family, and social life) plus perceived stress (PS) with significant loadings. The internal consistency of the SDS-4 was acceptable in patients with or without MDD, regardless of symptom severity. The SDS-4 also showed good discriminative capacity and acceptable predictive validity in all subsamples. CONCLUSIONS: These findings support the use of the SDS-4 to assess depression-related disability in patients at Spanish primary care centres.

Cost-Effectiveness and Cost-Utility Analysis of the Treatment of Emotional Disorders in Primary Care: PsicAP Clinical Trial. Description of the Sub-study Design.

Introduction: In the primary care (PC) setting in Spain, the prevalence of emotional disorders (EDs) such as anxiety, depression and somatoform disorder is high. In PC patients, these disorders are not always managed in accordance with the recommendations provided by clinical practice guidelines, resulting in major direct and indirect economic costs and suboptimal treatment outcomes. The aim is to analyze and compare the cost-effectiveness and cost-utility of group-based psychological therapy versus treatment as usual (TAU). Methods: Multicenter, randomized controlled trial involving 300 patients recruited from PC centers in Madrid, Spain, with symptoms or possible diagnosis of anxiety, mood (mild or moderate), or somatoform disorders. Patients will be randomized to one of two groups: an experimental group, which will receive group-based transdiagnostic cognitive-behavioral therapy (TD-CBT); and a control group, which will receive TAU (mainly pharmacological interventions) prescribed by their general practitioner (GP). Clinical assessment will be performed with the Patient Health Questionnaire (PHQ). Direct and indirect costs will be calculated and relevant socio-demographic variables will be registered. The Spanish version of the EuroQol 5D-5L will be administered. Patients will be assessed at baseline, immediately after treatment finalization, and at 6 and 12 months post-treatment. Discussion: To our knowledge, this is the first study to compare TD-CBT to TAU in the PC setting in Spain. This is the first comparative economic evaluation of these two treatment approaches in PC. The strength of the study is that it is a multicenter, randomized, controlled trial of psychotherapy and TAU for EDs in PC. Trial registration: Protocol code: ISCRCTN58437086; 20/05/2013.                                        EUDRACT: 2013-001955-11.                                        Protocol Version: 6, 11/01/2014.

Factor structure and measurement invariance across various demographic groups and over time for the PHQ-9 in primary care patients in Spain.

The Patient Health Questionnaire (PHQ-9) is a widely-used screening tool for depression in primary care settings. The purpose of the present study is to identify the factor structure of the PHQ-9 and to examine the measurement invariance of this instrument across different sociodemographic groups and over time in a sample of primary care patients in Spain. Data came from 836 primary care patients enrolled in a randomized controlled trial (PsicAP study) and a subsample of 218 patients who participated in a follow-up assessment at 3 months. Confirmatory factor analysis (CFA) was used to test one- and two-factor structures identified in previous studies. Analyses of multiple-group invariance were conducted to determine the extent to which the factor structure is comparable across various demographic groups (i.e., gender, age, marital status, level of education, and employment situation) and over time. Both one-factor and two-factor re-specified models met all the pre-established fit criteria. However, because the factors identified in the two-factor model were highly correlated (r = .86), the one-factor model was preferred for its parsimony. Multi-group CFA indicated measurement invariance across different demographic groups and across time. The present findings suggest that physicians in Spain can use the PHQ-9 to obtain a global score for depression severity in different demographic groups and to reliably monitor changes over time in the primary care setting.