We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Cognitive Behavioral Therapy for Anxiety and Depression in COPD

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.
ClinicalTrials.gov Identifier: NCT00545922
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : November 16, 2007
Information provided by:
University of Bergen

Brief Summary:
The purpose of this study was to examine the efficacy of manualized, short-term group cognitive behavioral therapy for COPD patients suffering from clinically significant symptoms of anxiety and/or depression.

Condition or disease Intervention/treatment Phase
Anxiety Depression Chronic Obstructive Pulmonary Disease Behavioral: Cognitive behavioral therapy Behavioral: Minimal Telephone Contact Phase 2

Detailed Description:

Anxiety and depressive disorders have been demonstrated in 16-50% of patients with chronic obstructive pulmonary disease (COPD), and clinically significant levels of anxiety or depressive symptoms seem to be even more common.Despite the multiple, severe consequences, majority of COPD patients with co-morbid anxiety or depression do not seem to receive any treatment for the psychological disturbance.

Cognitive behavioral therapy (CBT) is a well-known approach for treating anxiety and depression, and data has demonstrated effectiveness of CBT for older individuals with anxiety. CBT has also improved exercise tolerance compliance in COPD patients, and pilot studies using CBT components have shown effectiveness in improving mental health and functional status for patients with COPD.

Given the increasing number of patients suffering from COPD and the high prevalence of anxiety and depression in the population, the current study was designed to examine the efficacy of CBT in groups for anxiety and depression in patients with COPD. At present, CBT-based interventions focusing on mental health symptoms are not widely available for COPD patients, and the potential of CBT for improving emotional well-being is not systematically considered in existing treatment alternatives. The study expands the findings from previous pilot studies by focusing on COPD patients with clinically significant levels of anxiety and depression. The wide breadth of coping skills included in the CBT intervention target symptoms of both anxiety and depression, and thus the utility of the intervention for managing mental health symptoms is not restricted to any specific DSM-IV diagnosis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy for Anxiety and Depression for Patients With Chronic Obstructive Pulmonary Disease (COPD): A Randomized, Controlled Clinical Trial in an Outpatient Pulmonary Clinic.
Study Start Date : April 2005
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
7 weekly sessions of group cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy
Seven weekly sessions (2 hrs) in groups
Active Comparator: B
Minimal Telephone Contact
Behavioral: Minimal Telephone Contact
Telephone contact (max. 10 minutes) every other week during the 7-week intervention

Primary Outcome Measures :
  1. Beck Anxiety Inventory [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]
  2. Beck Depression Inventory-II [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]

Secondary Outcome Measures :
  1. St. George's Respiratory Questionnaire [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]
  2. Pittsburgh Sleep Quality Inventory [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]
  3. Actigraphy (Sleep effectiveness) [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]

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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 40 years or older
  • scores of 16 or higher on the Beck Anxiety Inventory and/or 14 or higher on the Beck Depression Inventory II
  • COPD diagnosis

Exclusion Criteria:

  • participation in other studies likely to influence the patient in terms of confounding effects
  • signs of cognitive impairment defined by a score of less than 23 on the Mini-Mental State Examination
  • presence of psychotic disorders, non-nicotine substance use disorders, bipolar disorders, or suicidal intentions as identified by clinical assessment based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID-I/P)
  • having a serious somatic condition preventing active participation in the present study

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 ClinicalTrials.gov identifier (NCT number): NCT00545922

Outpatient pulmonary clinic, Haukeland University Hospital
Bergen, Norway
Sponsors and Collaborators
University of Bergen
Study Director: Inger Hilde Nordhus, Dr. philos University of Bergen

ClinicalTrials.gov Identifier: NCT00545922     History of Changes
Other Study ID Numbers: REK 3.2007.1668
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: November 16, 2007
Last Verified: October 2007

Keywords provided by University of Bergen:
chronic obstructive pulmonary disease
cognitive behavioral therapy

Additional relevant MeSH terms:
Depressive Disorder
Anxiety Disorders
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases