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

July 23, 2013 updated by: Amale Jauregui Larrabeiti, Basque Health Service

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

246

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life Quality
Time Frame: The change from basal point to 2, 6 and 12 months
Change in the scale SF-36
The change from basal point to 2, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The change from baseline point to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Investigators

  • Principal Investigator: Amale Jauregui, Health Basdque Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 22, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSICCAPAD 2012
  • 2011111064 (Other Grant/Funding Number: Basque Health departament)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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