Cognitive Behavioral Therapy for Anxiety and Depression in COPD

NCT00545922 | Completed Phase 2

• 1 other identifier: REK 3.2007.1668
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Beck Anxiety Inventory

  Intervention period of 8 weeks, 6 month follow-up

• Beck Depression Inventory-II

  Intervention period of 8 weeks, 6 month follow-up

Secondary Outcomes (3)

• St. George's Respiratory Questionnaire

  Intervention period of 8 weeks, 6 month follow-up

• Pittsburgh Sleep Quality Inventory

  Intervention period of 8 weeks, 6 month follow-up

• Actigraphy (Sleep effectiveness)

  Intervention period of 8 weeks, 6 month follow-up

Study Arms (2)

A

EXPERIMENTAL

7 weekly sessions of group cognitive behavioral therapy

Behavioral: Cognitive behavioral therapy

B

ACTIVE COMPARATOR

Minimal Telephone Contact

Behavioral: Minimal Telephone Contact

Interventions

Cognitive behavioral therapy BEHAVIORAL

Seven weekly sessions (2 hrs) in groups

A

Minimal Telephone Contact BEHAVIORAL

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

B

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

Outpatient pulmonary clinic, Haukeland University Hospital

Bergen, Norway

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Pulmonary Disease, Chronic Obstructive

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Inger Hilde Nordhus, Dr. philos

  University of Bergen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: April 1, 2005
• Study Completion: November 1, 2007
• Last Updated: November 16, 2007

Record last verified: 2007-10

Locations

NO (1)