Anxiety-depressive Patients Mild to Moderate
Conditions
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.
Interventions
BEHAVIORALA 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)
OTHERUsual care
Sponsors
Basque Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Life Quality | The change from basal point to 2, 6 and 12 months | Change in the scale SF-36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of pharmacotherapy and sanitary services | The change from baseline point to 12 months | Change from basal point to one year in the use of pharmacotherapy and the use of sanitary services in primary care. |
Countries
Spain
Contacts
Primary ContactMaría Cruz Gómez
Backup ContactNatalia Burgos, Dr
Outcome results
None listed