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

This study has been completed.
Information provided by (Responsible Party):
Nestor Soler Porcar, Fundació Clínic per la Recerca Biomèdica Identifier:
First received: January 25, 2012
Last updated: August 11, 2015
Last verified: August 2015
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.

Condition Intervention
Chronic Obstructive Pulmonary Disease Anxiety Depression Behavioral: Counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

Further study details as provided by Nestor Soler Porcar, Fundació Clínic per la Recerca Biomèdica:

Primary Outcome Measures:
  • Efficacy of the intervention [ Time Frame: 6 months ]
    Counselling vs. usual care on re-hospitalizations

Secondary Outcome Measures:
  • Impact of diagnosis [ Time Frame: 6 months ]
    Anxiety/depression diagnosis on number of exacerbations at 1 and 6 months, comparing patients with screening on HADS test > 12

Enrollment: 169
Study Start Date: October 2011
Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01520376

Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Nestor Soler Porcar
Principal Investigator: Arturo Huerta, MD Hospital Clinic of Barcelona
  More Information

Responsible Party: Nestor Soler Porcar, Especialista Sènior, Fundació Clínic per la Recerca Biomèdica Identifier: NCT01520376     History of Changes
Other Study ID Numbers: ADPHA-EPOC
Study First Received: January 25, 2012
Last Updated: August 11, 2015

Additional relevant MeSH terms:
Depressive Disorder
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases processed this record on August 17, 2017