Cognitive Behavioral Therapy for Anxiety and Depression in COPD

NCT ID: NCT00545922

Last Updated: 2007-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-11-30

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.

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.

Conditions

Anxiety; Depression; Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; anxiety; depression; cognitive behavioral therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

7 weekly sessions of group cognitive behavioral therapy

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

Seven weekly sessions (2 hrs) in groups

B

Minimal Telephone Contact

Group Type: ACTIVE_COMPARATOR

Minimal Telephone Contact

Intervention Type: BEHAVIORAL

Telephone contact (max. 10 minutes) every other week during the 7-week intervention

Interventions

Cognitive behavioral therapy

Seven weekly sessions (2 hrs) in groups

Intervention Type: BEHAVIORAL

Minimal Telephone Contact

Telephone contact (max. 10 minutes) every other week during the 7-week intervention

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: lead

Principal Investigators

Inger Hilde Nordhus, Dr. philos

Role: STUDY_DIRECTOR

University of Bergen

Locations

Outpatient pulmonary clinic, Haukeland University Hospital

Bergen, , Norway

Countries

Norway

Other Identifiers

REK 3.2007.1668

Identifier Type: -

Identifier Source: org_study_id