Clinical trial NCT01694628: Cognitive Behavioral Therapy for COPD
Official title: Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2012-09-27
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Depressive Symptoms
timeFrame: 8 weeks
Secondary outcomes:
measure: Dyspnea Intensity and Distress
timeFrame: 8 weeks
measure: Fatigue
timeFrame: 8 weeks
measure: Anxiety
timeFrame: 8 weeks
measure: Physical Activity
timeFrame: 8 weeks
measure: Quality of Life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Lynn F Reinke, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: