چکیده (انگلیسی):

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).