Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD

NCT ID: NCT01520376

Last Updated: 2018-07-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-04-30

Brief Summary

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This study will try to elucidate wheter the impact of a psychiatric intervention in patients hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting at 1 and 6 month after discharge.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Counselling

People receiving a psychiatric evaluation after screening (HADS test \> 12 points) and revised at 1 and 6 months

Group Type ACTIVE_COMPARATOR

Counselling

Intervention Type BEHAVIORAL

Visit by a psychiatrist at day-30 and day-180 after discarge

Usual care

People after screening (HADS test \> 12 points) and send to their primary care physician

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Counselling

Visit by a psychiatrist at day-30 and day-180 after discarge

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Men and women of any ethnic group
* Above 40 years old
* Diagnose with Chronic Obstructive Pulmonary disease (COPD) according to the ATS/ERS guidelines
* Acute exacerbation of COPD according to the following criteria:

a) Cyanosis b) Obnubilations or mental confusion d) Respiratory Rate above 25 per minute e) Failure of ambulatory treatment f) Co-morbidities that worsens respiratory condition g) Dyspnea

Exclusion Criteria

* Less than 6 months expectancy of life
* Needing of mechanical ventilation
* Severe cardiovascular disease
* Pregnancy
* Previous diagnosis of depression/anxiety
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nestor Soler Porcar, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Nestor Soler Porcar, MD, PhD

Especialista Sènior

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Arturo Huerta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

Other Identifiers

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ADPHA-EPOC

Identifier Type: -

Identifier Source: org_study_id

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