Clinical trial NCT01907035: Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment
Official title: Improving Anxiety-depressive Disorder in Primary Care Applying a Cognitive-behavioral Treatment, Applied by Psychologists.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anxiety-depressive Patients Mild to Moderate
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2013-07-24
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVE: Evaluate the effectiveness of quality of life score, a cognitive-behavioral intervention by psychologists in the field of primary care in anxiety-depressive patients, mild to moderate, compared with usual care.

DESIGN: Clinical trial, multicenter, prospective, and randomized into two parallel groups. SCOPE AND SUBJECTS: We included a random sample of 246 patients anxious-depressive, mild / moderate, belonging to the target population of 41 doctors from several health centers. INTERVENTION: In the 246 patients randomly assigned to the intervention group, with a standardized program of cognitive behavioral therapy applied by psychologists, by the usual treatment or control group, which will be standard care. MEASUREMENTS: The main result will be changes in general health scores of the SF-36. It will also measure the change in frequency and intensity of anxiety-depressive symptoms on the scales HARS, HDRS, STAI and BDI at baseline and at 2, 6 and 12 months. In addition, also collected for drug use and health services.

ANALYSIS: Analyses were performed by intention to treat, comparing the change obtained in both groups at the end of the 12 month follow up. Estimates of the effect attributable to the intervention by the difference in those changes, adjusting in addition to the baseline, the possible confounding covariates or effect modifiers of the intervention, using longitudinal mixed-effects models.


Eligibility criteria: Inclusion Criteria:

* Primary care patients.
* Adults.
* Of both sexes.
* With disorder mixed anxiety-depressive mild-moderate active diagnosed by their general practitioner and showing more than 4 points in Goldberg-Anxiety, and more than 3 in Goldberg Depression.

Exclusion Criteria:

* Patients under 18 or over 75 years
* Patients with inability to understand, read or speak Spanish
* Patients with cognitive impairment
* Patients with severe disease which in the opinion of your doctor have a presumably fatal end during the 12 month follow-up
* Patients with psychotic disorders or other serious mental disease
* Patients with attempted suicide or suicidal ideation persistent
* Patients referred to Specialized Care
* Patients who are in private treatment
* Patients with high probability of loss to follow up.

Primary outcomes:
measure: Life Quality
timeFrame: The change from basal point to 2, 6 and 12 months
Secondary outcomes:
measure: Use of pharmacotherapy and sanitary services
timeFrame: The change from baseline point to 12 months
Other outcomes:
Locations:
city: Barakaldo
country: Spain
facility: Comarca Ezkerraldea
state: Bizkaia
city: Bilbao
country: Spain
facility: Comarca Bilbao
state: Bizkaia
city: Leioa
country: Spain
facility: Comarca Uribe
state: Bizkaia
Study officials:
affiliation: Health Basdque Service
name: Amale Jauregui
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jauregui A, Ponte J, Salgueiro M, Unanue S, Donaire C, Gomez MC, Burgos-Alonso N, Grandes G; Representing the PSICCAPAD Group. Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol. BMC Fam Pract. 2015 Mar 20;16:39. doi: 10.1186/s12875-015-0248-3.