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| ID | Type | Description | Link |
|---|---|---|---|
| 2011111064 | Other Grant/Funding Number | Basque Health departament |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-behavioral intervention | Experimental | Cognitive-behavioral intervention: Evaluate the effectiveness of a cognitive-behavioral intervention by psychologists in collaboration with practitioner plus routine therapy in the field of primary care 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) |
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| Usual care | Active Comparator | Family practice attention without the psychologist support |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A cognitive-behavioral intervention | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Life Quality | Change in the scale SF-36 | The change from basal point to 2, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María Cruz Gómez | Contact | 0034946006637 | mariacruz.gomezfernandez@osakidetza.net | |
| Natalia Burgos, Dr | Contact | 0034946006637 | natalia.burgosalonso@osakidetza.net |
| Name | Affiliation | Role |
|---|---|---|
| Amale Jauregui | Health Basdque Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comarca Ezkerraldea | Recruiting | Barakaldo | Bizkaia | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25879932 | Derived | Jauregui A, Ponte J, Salgueiro M, Unanue S, Donaire C, Gomez MC, Burgos-Alonso N, Grandes G; Representing the PSICCAPAD Group. Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol. BMC Fam Pract. 2015 Mar 20;16:39. doi: 10.1186/s12875-015-0248-3. |
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| Usual care | Other |
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| Comarca Bilbao | Recruiting | Bilbao | Bizkaia | Spain |
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| Comarca Uribe | Recruiting | Leioa | Bizkaia | Spain |
|