Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment
NCT ID: NCT01907035
Last Updated: 2013-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
246 participants
INTERVENTIONAL
2012-08-31
2015-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive-behavioral intervention
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)
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)
Usual care
Family practice attention without the psychologist support
Usual care
Interventions
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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)
Usual care
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Basque Health Service
OTHER_GOV
Responsible Party
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Amale Jauregui Larrabeiti
IPrincipal Investigator
Principal Investigators
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Amale Jauregui
Role: PRINCIPAL_INVESTIGATOR
Health Basdque Service
Locations
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Comarca Ezkerraldea
Barakaldo, Bizkaia, Spain
Comarca Bilbao
Bilbao, Bizkaia, Spain
Comarca Uribe
Leioa, Bizkaia, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2011111064
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PSICCAPAD 2012
Identifier Type: -
Identifier Source: org_study_id
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