Clinical trial NCT00545922: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Depression
Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
anxiety
depression
cognitive behavioral therapy
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2007-10-17
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Beck Anxiety Inventory
timeFrame: Intervention period of 8 weeks, 6 month follow-up
measure: Beck Depression Inventory-II
timeFrame: Intervention period of 8 weeks, 6 month follow-up
Secondary outcomes:
measure: St. George's Respiratory Questionnaire
timeFrame: Intervention period of 8 weeks, 6 month follow-up
measure: Pittsburgh Sleep Quality Inventory
timeFrame: Intervention period of 8 weeks, 6 month follow-up
measure: Actigraphy (Sleep effectiveness)
timeFrame: Intervention period of 8 weeks, 6 month follow-up
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Outpatient pulmonary clinic, Haukeland University Hospital
Study officials:
affiliation: University of Bergen
name: Inger Hilde Nordhus, Dr. philos
role: STUDY_DIRECTOR
References: