NCT01907035

Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment

Improving Anxiety-depressive Disorder in Primary Care Applying a Cognitive-behavioral Treatment, Applied by Psychologists.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Basque Health Service · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety-depressive Patients Mild to Moderate

Interventions

Type	Name	Description
BEHAVIORAL	A cognitive-behavioral intervention	Evaluate the effectiveness of a cognitive-behavioral intervention by psychologists in collaboration with MF plus routine therapy in the field of APS in anxiety-depressive patients mild to moderate, with respect to standardized usual care by physicians, improve quality of life of these people, producing at least ten-point increase in the level of overall quality of life (SF-36)
OTHER	Usual care

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-09-01
• Completion: 2015-12-01
• First posted: 2013-07-24
• Last updated: 2013-07-24

Locations

3 sites across 1 country: Spain