Cognitive Behavioral Therapy for COPD (CLIMB)

Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression; COPD
• Intervention / Treatment: Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior)

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual Care
Experimental: CLIMB (COPD Lifestyle, Mood, and Behavior); Counseling sessions for COPD and depression	Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior); Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Personal Health Questionnaire-9	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea Intensity and Distress	Chronic Respiratory Questionnaire, Shortness of Breath Questionnaire, Dyspnea Management Questionnaire	8 weeks
Fatigue	Chronic Respiratory Questionnaire	8 weeks
Anxiety	Hospital Anxiety and Depression Scale	8 weeks
Physical Activity	Accelerometry (Stepwatch)	8 weeks
Quality of Life	Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36	8 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Lynn F Reinke, PhD, RN, University of Washington

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 43252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO