Cognitive Behavioral Therapy for Anxiety and Depression in COPD
Primary Purpose
Anxiety, Depression, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Minimal Telephone Contact
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring chronic obstructive pulmonary disease, anxiety, depression, cognitive behavioral therapy
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
Sites / Locations
- Outpatient pulmonary clinic, Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
7 weekly sessions of group cognitive behavioral therapy
Minimal Telephone Contact
Outcomes
Primary Outcome Measures
Beck Anxiety Inventory
Beck Depression Inventory-II
Secondary Outcome Measures
St. George's Respiratory Questionnaire
Pittsburgh Sleep Quality Inventory
Actigraphy (Sleep effectiveness)
Full Information
NCT ID
NCT00545922
First Posted
October 16, 2007
Last Updated
November 14, 2007
Sponsor
University of Bergen
1. Study Identification
Unique Protocol Identification Number
NCT00545922
Brief Title
Cognitive Behavioral Therapy for Anxiety and Depression in COPD
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bergen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Chronic Obstructive Pulmonary Disease
Keywords
chronic obstructive pulmonary disease, anxiety, depression, cognitive behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
7 weekly sessions of group cognitive behavioral therapy
Arm Title
B
Arm Type
Active Comparator
Arm Description
Minimal Telephone Contact
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
Seven weekly sessions (2 hrs) in groups
Intervention Type
Behavioral
Intervention Name(s)
Minimal Telephone Contact
Intervention Description
Telephone contact (max. 10 minutes) every other week during the 7-week intervention
Primary Outcome Measure Information:
Title
Beck Anxiety Inventory
Time Frame
Intervention period of 8 weeks, 6 month follow-up
Title
Beck Depression Inventory-II
Time Frame
Intervention period of 8 weeks, 6 month follow-up
Secondary Outcome Measure Information:
Title
St. George's Respiratory Questionnaire
Time Frame
Intervention period of 8 weeks, 6 month follow-up
Title
Pittsburgh Sleep Quality Inventory
Time Frame
Intervention period of 8 weeks, 6 month follow-up
Title
Actigraphy (Sleep effectiveness)
Time Frame
Intervention period of 8 weeks, 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inger Hilde Nordhus, Dr. philos
Organizational Affiliation
University of Bergen
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient pulmonary clinic, Haukeland University Hospital
City
Bergen
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Cognitive Behavioral Therapy for Anxiety and Depression in COPD
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