Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD (ADPHA-EPOC)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Chronic Obstructive Pulmonary Disease; Anxiety
• Intervention / Treatment: Behavioral: Counselling

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Counselling; People receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months	Behavioral: Counselling; Visit by a psychiatrist at day-30 and day-180 after discarge
NO_INTERVENTION: Usual care; People after screening (HADS test > 12 points) and send to their primary care physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the intervention	Counselling vs. usual care on re-hospitalizations	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nestor Soler Porcar, MD, PhD
• Investigators: Principal Investigator: Arturo Huerta, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (ESTIMATE): January 27, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Respiratory Tract Diseases; Mood Disorders; Lung Diseases; Depression; Depressive Disorder; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ADPHA-EPOC