Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol

Amale Jauregui, Joaquín Ponte, Monika Salgueiro, Saloa Unanue, Carmen Donaire, Maria Cruz Gómez, Natalia Burgos-Alonso, Gonzalo Grandes, Representing the PSICCAPAD Group, Miren Albizuri, Amaia Andrés, Josune Aragón, Vital Arce, Maria Mar Baranda, Marta Barrena, Ana Baruque, Tomás Javier Berasategui, Ignacio José Berciano, Estela Cruz, Jose Ignácio Hernández, Esther Jiménez, Gaspar Lantarón, Cristina Lekube, Jose Manuel Liendo, Maria Mar Martinez, Itsaso Mendizábal, Maria Concepción Mendoza, Laura Narro, Maria Victoria Navarro, Cosme Naveda, Leyre Olabarrieta, Juan Carlos De Pablo, Amada Pereda, Ana Isabel Pereda, Elsa Ramos, Maria Angeles Rivas, Ana Rosa Rodríguez, Juan José Rodríguez, Jesús Ruiz, Carmen Sánchez, Idoia Santacoloma, Maria Angeles Santiago, Olaia Talavera, Mónica Rodríguez, Iñigo Valdivielso, Itxaso Zarandona, Amale Jauregui, Joaquín Ponte, Monika Salgueiro, Saloa Unanue, Carmen Donaire, Maria Cruz Gómez, Natalia Burgos-Alonso, Gonzalo Grandes, Representing the PSICCAPAD Group, Miren Albizuri, Amaia Andrés, Josune Aragón, Vital Arce, Maria Mar Baranda, Marta Barrena, Ana Baruque, Tomás Javier Berasategui, Ignacio José Berciano, Estela Cruz, Jose Ignácio Hernández, Esther Jiménez, Gaspar Lantarón, Cristina Lekube, Jose Manuel Liendo, Maria Mar Martinez, Itsaso Mendizábal, Maria Concepción Mendoza, Laura Narro, Maria Victoria Navarro, Cosme Naveda, Leyre Olabarrieta, Juan Carlos De Pablo, Amada Pereda, Ana Isabel Pereda, Elsa Ramos, Maria Angeles Rivas, Ana Rosa Rodríguez, Juan José Rodríguez, Jesús Ruiz, Carmen Sánchez, Idoia Santacoloma, Maria Angeles Santiago, Olaia Talavera, Mónica Rodríguez, Iñigo Valdivielso, Itxaso Zarandona

Abstract

Background: In contrast with the recommendations of clinical practice guidelines, the most common treatment for anxiety and depressive disorders in primary care is pharmacological. The aim of this study is to assess the efficacy of a cognitive-behavioural psychological intervention, delivered by primary care psychologists in patients with mixed anxiety-depressive disorder compared to usual care.

Methods/design: This is an open-label, multicentre, randomized, and controlled study with two parallel groups. A random sample of 246 patients will be recruited with mild-to-moderate mixed anxiety-depressive disorder, from the target population on the lists of 41 primary care doctors. Patients will be randomly assigned to the intervention group, who will receive standardised cognitive-behavioural therapy delivered by psychologists together with usual care, or to a control group, who will receive usual care alone. The cognitive-behavioural therapy intervention is composed of eight individual 60-minute face-to face sessions conducted in eight consecutive weeks. A follow-up session will be conducted over the telephone, for reinforcement or referral as appropriate, 6 months after the intervention, as required. The primary outcome variable will be the change in scores on the Short Form-36 General Health Survey. We will also measure the change in the frequency and intensity of anxiety symptoms (State-Trait Anxiety Inventory) and depression (Beck Depression Inventory) at baseline, and 3, 6 and 12 months later. Additionally, we will collect information on the use of drugs and health care services.

Discussion: The aim of this study is to assess the efficacy of a primary care-based cognitive-behavioural psychological intervention in patients with mixed anxiety-depressive disorder. The international scientific evidence has demonstrated the need for psychologists in primary care. However, given the differences between health policies and health services, it is important to test the effect of these psychological interventions in our geographical setting.

Trial registration: NCT01907035 (July 22, 2013).

Figures

Figure 1
Figure 1
Flow chart of patient recruitment and randomisation.

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