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

October 16, 2007
October 17, 2007
November 16, 2007
April 2005
Not Provided
  • Beck Anxiety Inventory [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]
  • Beck Depression Inventory-II [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]
Same as current
Complete list of historical versions of study NCT00545922 on Archive Site
  • St. George's Respiratory Questionnaire [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]
  • Pittsburgh Sleep Quality Inventory [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]
  • Actigraphy (Sleep effectiveness) [ Time Frame: Intervention period of 8 weeks, 6 month follow-up ]
Same as current
Not Provided
Not Provided
Cognitive Behavioral Therapy for Anxiety and Depression in COPD
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.
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Anxiety
  • Depression
  • Chronic Obstructive Pulmonary Disease
  • Behavioral: Cognitive behavioral therapy
    Seven weekly sessions (2 hrs) in groups
  • Behavioral: Minimal Telephone Contact
    Telephone contact (max. 10 minutes) every other week during the 7-week intervention
  • Experimental: A
    7 weekly sessions of group cognitive behavioral therapy
    Intervention: Behavioral: Cognitive behavioral therapy
  • Active Comparator: B
    Minimal Telephone Contact
    Intervention: Behavioral: Minimal Telephone Contact
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2007
Not Provided

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
REK 3.2007.1668
Not Provided
Not Provided
Not Provided
University of Bergen
Not Provided
Study Director: Inger Hilde Nordhus, Dr. philos University of Bergen
University of Bergen
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP