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OpenTrials
Completed

NCT Number: NCT01520376

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chronic Disease Depression Disease Attributes Lung Diseases Lung Diseases, Obstructive Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counselling

Behavioral

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

Primary outcomes

  1. Efficacy of the intervention

    Time frame: 6 months

    Counselling vs. usual care on re-hospitalizations

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nestor Soler Porcar, MD, PhD

Other

Registry information

Official study 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

Acronym: ADPHA-EPOC

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 27, 2012
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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