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

July Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety- depressive disorder: a research protocol Amale Jauregui 0 Joaqun Ponte 2 Monika Salgueiro 1 Saloa Unanue 0 Carmen Donaire Maria Cruz Gmez Natalia Burgos-Alonso 1 Gonzalo Grandes 1 representing the PSICCAPAD group 0 Sopela Health Centre, Basque Health Service (Osakidetza) , Sopela , Spain 1 Primary Care Research Unit 2 Ortuella Mental Health Service , Ortuella , Spain 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. Anxiety; Depression; Cognitive-behavioural therapy; Primary care - Background The prevalence of mental disorders in primary care (PC) in Europe is around 20-55% [1-3]. In association with the current economic crisis, there has been an alarming increase of PC consultations for psychological distress [4,5]. It has been estimated that a quarter of patients who attend PC consultations have had a mental disorder in the previous year, in particular problems related to anxiety and/or depression [1,2,6,7]. In our multi-tiered public health system, around 85-90% of these patients are treated in PC settings [8]. Among mood disorders, the coexistence of anxiety and depression is the norm rather than the exception [9]. Specifically, adjustment disorders are very common, that is, signs and symptoms of mixed anxiety/depression in the context of changing situations that force people to adjust to new situations [1,10]. Clinical practice guidelines recommend cognitive-behavioural therapy (CBT) as the treatment of choice for affective and mood disorders. The use of psychoactive drugs is only recommended for the most severe cases and always in combination with psychological treatment [11-14]. However, the real adherence to these evidence-based clinical guidelines is very poor in general, and several studies have shown that in PC psychoactive drugs are more widely used than psychological techniques, [15]. In relation of this, the Strategy for Mental Health of the Spanish National Health Service recognised that that there has been a significant medicalization of everyday life and that there is a tendency towards an overuse of pharmacological approaches, these requiring less time, as well as less professional expertise and involvement, for the treatment of disorders that should be addressed with specific psychological interventions [16]. There is strong evidence that the efficacy of psychological therapy and CBT in particular, is the same as or greater than pharmacological treatments of the most common affective and anxiety disorders, as well as it having greater long-term effectiveness [17-19]. Notably, the benefits of psychological approaches include a reduction in symptoms associated with anxiety and depression, a decrease in the risk of relapses, the stability of the effect of the treatment in the long term, and high rates of recovery, preventing the condition becoming chronic and decreasing health (...truncated)