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Anxiety-depressive Disorder in Primary Care and Cognitive-behavioral Treatment (PSICCAPAD)

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ClinicalTrials.gov Identifier: NCT01907035
Recruitment Status : Unknown
Verified July 2013 by Amale Jauregui Larrabeiti, Basque Health Service.
Recruitment status was:  Recruiting
First Posted : July 24, 2013
Last Update Posted : July 24, 2013
Sponsor:
Information provided by (Responsible Party):
Amale Jauregui Larrabeiti, Basque Health Service

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.


Condition or disease Intervention/treatment Phase
Anxiety-depressive Patients Mild to Moderate Behavioral: A cognitive-behavioral intervention Other: Usual care Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Anxiety-depressive Disorder in Primary Care Applying a Cognitive-behavioral Treatment, Applied by Psychologists.
Study Start Date : August 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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)
Behavioral: 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)

Active Comparator: Usual care
Family practice attention without the psychologist support
Other: Usual care



Primary Outcome Measures :
  1. Life Quality [ Time Frame: The change from basal point to 2, 6 and 12 months ]
    Change in the scale SF-36


Secondary Outcome Measures :
  1. Use of pharmacotherapy and sanitary services [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907035


Contacts
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Contact: María Cruz Gómez 0034946006637 mariacruz.gomezfernandez@osakidetza.net
Contact: Natalia Burgos, Dr 0034946006637 natalia.burgosalonso@osakidetza.net

Locations
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Spain
Comarca Ezkerraldea Recruiting
Barakaldo, Bizkaia, Spain
Contact: Amale Jauregui    0034946006637    AMALE.JAUREGUILARRABEITI@osakidetza.net   
Contact: Maria Cruz Gómez    0034946006637    mariacruz.gomezfernandez@osakidetza.net   
Comarca Bilbao Recruiting
Bilbao, Bizkaia, Spain
Contact: Amale Jauregui    0034946006637    AMALE.JAUREGUILARRABEITI@osakidetza.net   
Contact: Maria Cruz Gómez    0034946006637    mariacruz.gomezfernandez@osakidetza.net   
Comarca Uribe Recruiting
Leioa, Bizkaia, Spain
Contact: Amale Jauregui    0034946006637    AMALE.JAUREGUILARRABEITI@osakidetza.net   
Contact: Maria Cruz Gómez    0034946006637    mariacruz.gomezfernandez@osakidetza.net   
Sponsors and Collaborators
Basque Health Service
Investigators
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Principal Investigator: Amale Jauregui Health Basdque Service

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amale Jauregui Larrabeiti, IPrincipal Investigator, Basque Health Service
ClinicalTrials.gov Identifier: NCT01907035     History of Changes
Other Study ID Numbers: PSICCAPAD 2012
2011111064 ( Other Grant/Funding Number: Basque Health departament )
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Anxiety Disorders
Depressive Disorder
Mental Disorders
Mood Disorders