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

Depression Clinical Trial

— ADPHA-EPOC  

Official title:

A Prospective Randomized Trial to Asses the Efficacy of an Early Psychiatric Counseling Compared to Usual Care in a Cohort of Patients Hospitalized for an Acute Exacerbation of COPD in Prevention of Re-exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520376
• Other study ID #: ADPHA-EPOC
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2018
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Chronic Obstructive Pulmonary Disease
• Depression
• Depressive Disorder
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Counselling
Visit by a psychiatrist at day-30 and day-180 after discarge

Locations

Country	Name	City	State
Spain	Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Nestor Soler Porcar, MD, PhD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the intervention	Counselling vs. usual care on re-hospitalizations	6 months
Secondary	Impact of diagnosis	Anxiety/depression diagnosis on number of exacerbations at 1 and 6 months, comparing patients with screening on HADS test > 12	6 months