Cognitive Behavioral Therapy for Anxiety and Depression in COPD

November 14, 2007 updated by: University of Bergen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Outpatient pulmonary clinic, Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Beck Anxiety Inventory
Time Frame: Intervention period of 8 weeks, 6 month follow-up
Intervention period of 8 weeks, 6 month follow-up
Beck Depression Inventory-II
Time Frame: Intervention period of 8 weeks, 6 month follow-up
Intervention period of 8 weeks, 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
St. George's Respiratory Questionnaire
Time Frame: Intervention period of 8 weeks, 6 month follow-up
Intervention period of 8 weeks, 6 month follow-up
Pittsburgh Sleep Quality Inventory
Time Frame: Intervention period of 8 weeks, 6 month follow-up
Intervention period of 8 weeks, 6 month follow-up
Actigraphy (Sleep effectiveness)
Time Frame: Intervention period of 8 weeks, 6 month follow-up
Intervention period of 8 weeks, 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Investigators

  • Study Director: Inger Hilde Nordhus, Dr. philos, University of Bergen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

November 16, 2007

Last Update Submitted That Met QC Criteria

November 14, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 3.2007.1668

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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