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Completed

NCT Number: NCT00545922

Cognitive Behavioral Therapy for Anxiety and Depression in COPD

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Outpatient pulmonary clinic, Haukeland University Hospital

Bergen, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Seven weekly sessions (2 hrs) in groups

Minimal Telephone Contact

Behavioral

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

Primary outcomes

  1. Beck Anxiety Inventory

    Time frame: Intervention period of 8 weeks, 6 month follow-up

  2. Beck Depression Inventory-II

    Time frame: Intervention period of 8 weeks, 6 month follow-up

Secondary outcomes

  1. St. George's Respiratory Questionnaire

    Time frame: Intervention period of 8 weeks, 6 month follow-up

  2. Pittsburgh Sleep Quality Inventory

    Time frame: Intervention period of 8 weeks, 6 month follow-up

  3. Actigraphy (Sleep effectiveness)

    Time frame: Intervention period of 8 weeks, 6 month follow-up

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study 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.

Important dates

Study start
2005
Study completion
2007
First posted
Oct 17, 2007
Registry last updated
Nov 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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