Paloma Ruiz-Rodríguez

Transdiagnostic Cognitive Behavioral Therapy Versus Treatment as Usual in Adult Patients With Emotional Disorders in the Primary Care Setting (PsicAP Study): Protocol for a Randomized Controlled Trial

Background Demand for primary care (PC) services in Spain exceeds available resources. Part of this strong demand is due to the high prevalence of emotional disorders (EDs)—anxiety, depression, and somatic symptom disorders—and related comorbidities such as pain or chronic illnesses. EDs are often under- or misdiagnosed by general practitioners (GPs) and, consequently, treatment is frequently inadequate. Objective We aim to compare the short- and long-term effectiveness of group-delivered transdiagnostic cognitive behavioral therapy (TD-CBT) versus treatment as usual (TAU) in the treatment of EDs in the PC setting in Spain. We also aim to compare the effect of these treatments on disability, quality of life, cognitive-emotional factors, and treatment satisfaction. Methods Here we present the study design of a two-arm, single-blind, randomized controlled trial (N=1126) to compare TAU to TD-CBT for EDs. TAU will consist primarily of pharmacological treatment and practical advice from the GP while TD-CBT will be administered in seven 90-minute group sessions held over a period ranging from 12 to 14 weeks. Psychological assessments are carried out at baseline (ie, pretreatment); posttreatment; and at 3-, 6-, and 12-month follow-up. The study is conducted in approximately 26 PC centers from the National Health System in Spain. Results This study was initiated in December 2013 and will remain open to new participants until recruitment and follow-up has been completed. We expect all posttreatment evaluations to be completed by December 2017, and follow-up will end in December 2018. Conclusions We expect the TD-CBT group to have better results compared to TAU on all posttreatment measures and that this improvement will be maintained during follow-up. This project could serve as a model for use in other areas or services of the National Health System in Spain and even in other countries. ClinicalTrial International Standard Randomized Controlled Trial Number (ISRCTN): 58437086; http://www.isrctn.com/ISRCTN58437086 (Archived by WebCite at http://www.webcitation.org/6mbYjQSn3)

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

BackgroundThe 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.MethodsA 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.ResultsThe 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.ConclusionsAs 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 registrationCurrent Controlled Trials ISRCTN58437086. Registered 20 May 2013.

The PHQ-PD as a Screening Tool for Panic Disorder in the Primary Care Setting in Spain

Introduction Panic disorder is a common anxiety disorder and is highly prevalent in Spanish primary care centres. The use of validated tools can improve the detection of panic disorder in primary care populations, thus enabling referral for specialized treatment. The aim of this study is to determine the accuracy of the Patient Health Questionnaire-Panic Disorder (PHQ-PD) as a screening and diagnostic tool for panic disorder in Spanish primary care centres. Method We compared the psychometric properties of the PHQ-PD to the reference standard, the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) interview. General practitioners referred 178 patients who completed the entire PHQ test, including the PHQ-PD, to undergo the SCID-I. The sensitivity, specificity, positive and negative predictive values and positive and negative likelihood ratios of the PHQ-PD were assessed. Results The operating characteristics of the PHQ-PD are moderate. The best cut-off score was 5 (sensitivity .77, specificity .72). Modifications to the questionnaires algorithms improved test characteristics (sensitivity .77, specificity .72) compared to the original algorithm. The screening question alone yielded the highest sensitivity score (.83). Conclusion Although the modified algorithm of the PHQ-PD only yielded moderate results as a diagnostic test for panic disorder, it was better than the original. Using only the first question of the PHQ-PD showed the best psychometric properties (sensitivity). Based on these findings, we suggest the use of the screening questions for screening purposes and the modified algorithm for diagnostic purposes.

Screening for generalized anxiety disorder in Spanish Primary Care Centers with the GAD-7

The aim of the study was to determine the criterion validity of a computerized version of the General Anxiety Disorder-7 (GAD-7) questionnaire to detect general anxiety disorder in Spanish primary care centers. A total of 178 patients completed the GAD-7 and were administered the Composite International Diagnostic Interview (CIDI) for DSM-IV Axis I Disorders, which was used as a reference standard. Sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios were calculated. A cut-off of 10 yielded a sensitivity of .87, a specificity of .78, a positive predictive value of .93, a negative predictive value of .64, a positive likelihood ratio of 3.96 a negative likelihood ratio of .17 and Youndens Index of .65. The GAD-7 performed very well with a cut-off value of 10, the most frequently used cut-off point. Thus, a computerized version of the GAD-7 is an excellent screening tool for detecting general anxiety disorder in Spanish primary care settings.

The association between different domains of quality of life and symptoms in primary care patients with emotional disorders

Despite the importance of quality of life (QoL) in primary care patients with emotional disorders, the specific influence of the symptoms of these disorders and the sociodemographic characteristics of patients on the various QoL domains has received scant attention. The aim of the present study of primary care patients with emotional disorders was to analyse the associations between four different QoL domains and the most prevalent clinical symptoms (i.e., depression, anxiety and somatization), while controlling for sociodemographic variables. A total of 1241 participants from 28 primary care centres in Spain were assessed with the following instruments: the Patient Health Questionnaire (PHQ)-9 to evaluate depression; the Generalized Anxiety Disorder Scale (GAD)-7 for anxiety; PHQ-15 for somatization; and the World Health Organization Quality of Life Instrument-Short Form (WHOQOL-Bref) to assess four broad QoL domains: physical health, psychological health, social relationships, and environment. The associations between the symptoms and QoL domains were examined using hierarchical regression analyses. Adjusted QoL mean values as a function of the number of overlapping diagnoses were calculated. The contribution of sociodemographic variables to most QoL domains was modest, explaining anywhere from 2% to 11% of the variance. However, adding the clinical variables increased the variance explained by 12% to 40% depending on the specific QoL domain. Depression was the strongest predictor for all domains. The number of overlapping diagnoses adversely affected all QoL domains, with each additional diagnosis reducing the main QoL subscales by 5 to 10 points. In primary care patients with a diagnostic impression of an emotional disorders as identified by their treating GP, clinical symptoms explained more of the variance in QoL than sociodemographic factors such as age, sex, level of education, marital status, work status, and income. Given the strong relationship between depressive symptoms and QoL, treatment of depression may constitute a key therapeutic target to improve QoL in people with emotional disorders in primary care.

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.

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.