Anxiety-depressive Patients Mild to Moderate Clinical Trial
Official title:
Improving Anxiety-depressive Disorder in Primary Care Applying a Cognitive-behavioral Treatment, Applied by Psychologists.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment