Anxiety-depressive Patients Mild to Moderate Clinical Trial
— PSICCAPADOfficial 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.
| Status | Recruiting |
| Enrollment | 246 |
| Est. completion date | December 2015 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Comarca Ezkerraldea | Barakaldo | Bizkaia |
| Spain | Comarca Bilbao | Bilbao | Bizkaia |
| Spain | Comarca Uribe | Leioa | Bizkaia |
| Lead Sponsor | Collaborator |
|---|---|
| Basque Health Service |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Life Quality | Change in the scale SF-36 | The change from basal point to 2, 6 and 12 months | No |
| Secondary | Use of pharmacotherapy and sanitary services | Change from basal point to one year in the use of pharmacotherapy and the use of sanitary services in primary care. | The change from baseline point to 12 months | No |