Cognitive Behavioral Therapy for COPD

Study Overview
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Brief Summary
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The purpose of this study in patients with advanced COPD and depression is twofold: Determine the feasibility and acceptability of a 6-session e-counseling intervention 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
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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

Official Title
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Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression

Conditions
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COPD, Depression

Intervention / Treatment
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* Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |