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Clinical Trials/NCT01907035
NCT01907035
Unknown
Phase 3

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

Basque Health Service3 sites in 1 country246 target enrollmentAugust 2012

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Anxiety-depressive Patients Mild to Moderate
Sponsor
Basque Health Service
Enrollment
246
Locations
3
Primary Endpoint
Life Quality
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Basque Health Service
Responsible Party
Principal Investigator
Principal Investigator

Amale Jauregui Larrabeiti

IPrincipal Investigator

Basque Health Service

Eligibility Criteria

Inclusion Criteria

  • Primary care patients.
  • 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.

Outcomes

Primary Outcomes

Life Quality

Time Frame: The change from basal point to 2, 6 and 12 months

Change in the scale SF-36

Secondary Outcomes

  • Use of pharmacotherapy and sanitary services(The change from baseline point to 12 months)

Study Sites (3)

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