e-Counseling for COPD (CLIMB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Washington
Sponsor:
Collaborator:
National Palliative Care and Research Center
Information provided by (Responsible Party):
Lynn Foster Reinke, University of Washington
ClinicalTrials.gov Identifier:
NCT01694628
First received: September 24, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
COPD
Depression
Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Depressive Symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Personal Health Questionnaire-9


Secondary Outcome Measures:
  • Dyspnea Intensity and Distress [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Chronic Respiratory Questionnaire, Shortness of Breath Questionnaire, Dyspnea Management Questionnaire

  • Fatigue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Chronic Respiratory Questionnaire

  • Anxiety [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale

  • Physical Activity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Accelerometry (Stepwatch)

  • Quality of Life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36


Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLIMB (COPD Lifestyle, Mood, and Behavior)
CLIMB: 6 e-counseling sessions delivered via videoconferencing in patient homes
Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior)
No Intervention: Control

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694628

Contacts
Contact: Lynn Reinke, PhD, RN (206) 277-4186 reinkl@uw.edu
Contact: Sara Fleehart, MS 206-685-6536 fleehart@uw.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Sara Fleehart, MS    206-685-6536    climb1@uw.edu   
Sub-Investigator: Vincent Fan, MD, MPH         
Sub-Investigator: Catherine Kirkness, PhD, RN         
Sub-Investigator: Soo Borson, MD         
Sub-Investigator: Ruth Kohen, MD         
Sub-Investigator: Randall Curtis, MD, MPH         
Sub-Investigator: Huong Q Nguyen, PhD, RN         
Sub-Investigator: Ranak Trivedi, PhD         
Sub-Investigator: Jerald Herting, PhD         
Sponsors and Collaborators
University of Washington
National Palliative Care and Research Center
Investigators
Principal Investigator: Lynn F Reinke, PhD, RN University of Washington
  More Information

No publications provided

Responsible Party: Lynn Foster Reinke, Clinical Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01694628     History of Changes
Other Study ID Numbers: NPCRC Pilot Grant
Study First Received: September 24, 2012
Last Updated: November 29, 2012
Health Authority: United States: UW Human Subjects Division

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 22, 2014