Cognitive Behavioral Therapy for COPD

NCT ID: NCT01694628

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-10-31

Brief Summary

The purpose of this study in patients with advanced COPD and depression is twofold:

1. Determine the feasibility and acceptability of a 6-session e-counseling intervention

2. Determine the efficacy of the e-counseling intervention on depressive symptoms

We hypothesize that patients who participate in e-counseling will have improved depressive symptoms compared to patients receiving usual care at 8 weeks.

Detailed Description

Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the US. Although COPD is mostly preventable, there is no cure. Thus, care of patients with COPD is primarily focused on symptom palliation with the goal of improving quality of life for both patients and their families. These goals are highly consistent with core principles of palliative care. Dyspnea is the most distressing symptom for patients. Even optimal disease-directed treatment provides only partial relief from dyspnea. Depression is consistently associated with worse dyspnea, but the mechanisms underlying this relationship are poorly understood. Since existing treatment for dyspnea has only limited success and there is evidence that treating depression alleviates pain, we propose that by improving mood, we may be more successful in alleviating dyspnea. Psychosocial-behavioral therapy (PBT) which is focused on increasing pleasant events and improving problem solving skills has been shown to have immediate and sustained effects on depressive symptoms in patients with dementia and post-stroke holds tremendous promise for efficacy in advanced COPD. Testing the use of novel technologies to provide efficacious interventions such as PBT to patients with advanced disease is critical for translational palliative care research

Conditions

COPD; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CLIMB (COPD Lifestyle, Mood, and Behavior)

Counseling sessions for COPD and depression

Group Type: EXPERIMENTAL

CLIMB (COPD Lifestyle, Mood, and Behavior)

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.

Control

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CLIMB (COPD Lifestyle, Mood, and Behavior)

Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• COPD (FEV1/FVC < 70% & FEV1 <80%; current or past smoking >10pack-years)
• Depressed (PHQ-9 >=10)
• Ability to speak, read and write English
• Willingness to use computer or study-issued tablet device

Exclusion Criteria

• Current non-nicotine substance abuse or dependence
• Psychotic disorder
• Active suicide ideation with intent and plan
• Alzheimer's/dementia
• Currently receiving any psychotherapy

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Lynn Foster Reinke

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynn F Reinke, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

43252

Identifier Type: -

Identifier Source: org_study_id