Cognitive Behavioral Therapy for Anxiety and Depression in COPD

Depression Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545922
• Other study ID #: REK 3.2007.1668
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2007
• Last updated: November 14, 2007
• Start date: April 2005
• Est. completion date: November 2007

Study information

• Verified date: October 2007
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Chronic Obstructive Pulmonary Disease
• Depression
• Depressive Disorder
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Cognitive behavioral therapy
Seven weekly sessions (2 hrs) in groups
• Minimal Telephone Contact
Telephone contact (max. 10 minutes) every other week during the 7-week intervention

Locations

Country	Name	City	State
Norway	Outpatient pulmonary clinic, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Anxiety Inventory		Intervention period of 8 weeks, 6 month follow-up
Primary	Beck Depression Inventory-II		Intervention period of 8 weeks, 6 month follow-up
Secondary	St. George's Respiratory Questionnaire		Intervention period of 8 weeks, 6 month follow-up
Secondary	Pittsburgh Sleep Quality Inventory		Intervention period of 8 weeks, 6 month follow-up
Secondary	Actigraphy (Sleep effectiveness)		Intervention period of 8 weeks, 6 month follow-up