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Clinical Trials/NCT01694628
NCT01694628CompletedNot Applicable

Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression

University of Washington2 sites in 1 country18 target enrollmentStarted: September 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Depressive Symptoms

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Depressive Symptoms

Time Frame: 8 weeks

Personal Health Questionnaire-9

Secondary Outcomes

  • Fatigue(8 weeks)
  • Quality of Life(8 weeks)
  • Anxiety(8 weeks)
  • Physical Activity(8 weeks)
  • Dyspnea Intensity and Distress(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lynn Foster Reinke

Clinical Associate Professor

University of Washington

Study Sites (2)

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