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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520376
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : August 13, 2015
Information provided by (Responsible Party):
Nestor Soler Porcar, Fundacion Clinic per a la Recerca Biomédica

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Anxiety Depression Behavioral: Counselling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Nestor Soler Porcar, Especialista Sènior, Fundacion Clinic per a la Recerca Biomédica Identifier: NCT01520376     History of Changes
Other Study ID Numbers: ADPHA-EPOC
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 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