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

Abstract

BackgroundDemand 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.ObjectiveWe 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.MethodsHere 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.ResultsThis 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.ConclusionsWe 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.ClinicalTrialInternational 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

“…In fact, based on those findings, Zimmerman et al [ 37 ] called for caution in using the PHQ-9 to guide treatment selection until the thresholds to define severity ranges have been empirically established. Importantly, based on these findings, we have since modified the protocol of the PsicAP study [ 28 ] to prevent misuse: patients with PHQ-9 scores above 20 are automatically interviewed with the SCID-I to confirm the severity of their depression. Another limitation is that many patients that participated in our study presented symptoms of other emotional disorders, such as anxiety, somatizations, and mood disorders.…”

“…The study was conducted from January to December 2014 at five PC centres participating in the larger PsicAP study [ 28 ], a clinical trial designed to evaluate the diagnosis and treatment of emotional disorders among PC patients in Spain. The centres are located in several cities in Spain (two in Valencia, and one each in Albacete, Vizcaya, and Mallorca).…”

“…The Spanish Version of this semi-structured interview [ 31 ] was conducted by clinical psychologists (7 in total) who had received intensive training by an expert clinical psychologist (see Cano-Vindel et al [ 28 ] for more details). The interview sessions were supervised by the same clinical psychologist for the duration of the study.…”

“…Patients with anxious, depressive or physical symptoms without a clear biological basis were asked by the GPs to participate in the PsicAP clinical trial (see Cano-Vindel et al [ 28 ]). They received the Patient Information Sheet and provided informed consent.…”

Screening for generalized anxiety disorder in Spanish primary care centers with the GAD-7

“…The study sample included PC patients aged 18 to 65 years old. From among the 14 PC centers of the public health system involved in the PsicAP study (Cano-Vindel et al, 2016), we selected five centers from different cities of Spain (two in Valencia and one each in Albacete, Vizcaya and Mallorca) to recruit the sample. The ethics committees of each center, the National Ethics Committee, and the Spanish Agency of Medicines and Medical Devices (AEMPS), all approved the study protocol (code: ISRCTN58437086).…”