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

Jauregui A, Ponte J, Salgueiro M, Unanue S, Donaire C, Gómez MC, Burgos-Alonso N, Grandes G, Representing the PSICCAPAD Gro - BMC Fam Pract (2015)

Bottom Line: 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.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.NCT01907035 (July 22, 2013).

View Article: PubMed Central - PubMed

Affiliation: Sopela Health Centre, Basque Health Service (Osakidetza), Sopela, Spain. amale.jaureguilarrabeiti@osakidetza.net.

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).

No MeSH data available.


Related in: MedlinePlus

Flow chart of patient recruitment and randomisation.
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Fig1: Flow chart of patient recruitment and randomisation.

Mentions: Eligible subjects will be: patients of the participating health centres, over 18 years of age, who have been diagnosed by their GP with mild-to-moderate mixed anxiety-depressive disorder, and obtained scores of at least 4 on the anxiety subscale and at least 3 on the depression subscale of the Goldberg Anxiety and Depression Scale (GADS) [28,29] (see Figure 1 for an overview). We will apply the following exclusion criteria: being over 75 years old; not being able to understand and/or speak Spanish; or having cognitive impairment that could interfere with assessments or intervention; a serious disease or medical condition that could result in death in the following 12 months or a high probability of loss to follow up; or a psychotic or other severe mental illness, as well as a history of suicide attempts or persistent suicidal ideation. Patients who referred to specialised care and any under psychological treatment in the private sector will also be excluded.Figure 1


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

Jauregui A, Ponte J, Salgueiro M, Unanue S, Donaire C, Gómez MC, Burgos-Alonso N, Grandes G, Representing the PSICCAPAD Gro - BMC Fam Pract (2015)

Flow chart of patient recruitment and randomisation.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4373067&req=5

Fig1: Flow chart of patient recruitment and randomisation.
Mentions: Eligible subjects will be: patients of the participating health centres, over 18 years of age, who have been diagnosed by their GP with mild-to-moderate mixed anxiety-depressive disorder, and obtained scores of at least 4 on the anxiety subscale and at least 3 on the depression subscale of the Goldberg Anxiety and Depression Scale (GADS) [28,29] (see Figure 1 for an overview). We will apply the following exclusion criteria: being over 75 years old; not being able to understand and/or speak Spanish; or having cognitive impairment that could interfere with assessments or intervention; a serious disease or medical condition that could result in death in the following 12 months or a high probability of loss to follow up; or a psychotic or other severe mental illness, as well as a history of suicide attempts or persistent suicidal ideation. Patients who referred to specialised care and any under psychological treatment in the private sector will also be excluded.Figure 1

Bottom Line: 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.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.NCT01907035 (July 22, 2013).

View Article: PubMed Central - PubMed

Affiliation: Sopela Health Centre, Basque Health Service (Osakidetza), Sopela, Spain. amale.jaureguilarrabeiti@osakidetza.net.

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).

No MeSH data available.


Related in: MedlinePlus