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Cognitive Behavioral Therapy for Anxiety and Depression in COPD

This study has been completed.
Sponsor:
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT00545922
First received: October 16, 2007
Last updated: November 14, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention Phase
Anxiety
Depression
Chronic Obstructive Pulmonary Disease
 Behavioral: Cognitive behavioral therapy
Behavioral: Minimal Telephone Contact
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 51
Study Start Date: April 2005
Study Completion Date: November 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545922

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

No publications provided

ClinicalTrials.gov Identifier: NCT00545922     History of Changes
Other Study ID Numbers: REK 3.2007.1668
Study First Received: October 16, 2007
Last Updated: November 14, 2007
Health Authority: Norway: Data Protection Authority
Norway: Norwegian Social Science Data Services

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

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

ClinicalTrials.gov processed this record on June 19, 2013