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Cognitive Behavioral Therapy for COPD (CLIMB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694628
First Posted: September 27, 2012
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Lynn Foster Reinke, University of Washington
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression

Further study details as provided by Lynn Foster Reinke, University of Washington:

Primary Outcome Measures:
  • Depressive Symptoms [ Time Frame: 8 weeks ]
    Personal Health Questionnaire-9


Secondary Outcome Measures:
  • Dyspnea Intensity and Distress [ Time Frame: 8 weeks ]
    Chronic Respiratory Questionnaire, Shortness of Breath Questionnaire, Dyspnea Management Questionnaire

  • Fatigue [ Time Frame: 8 weeks ]
    Chronic Respiratory Questionnaire

  • Anxiety [ Time Frame: 8 weeks ]
    Hospital Anxiety and Depression Scale

  • Physical Activity [ Time Frame: 8 weeks ]
    Accelerometry (Stepwatch)

  • Quality of Life [ Time Frame: 8 weeks ]
    Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36


Enrollment: 18
Study Start Date: September 2012
Study Completion Date: October 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control
Usual Care

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694628


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Lynn F Reinke, PhD, RN University of Washington
  More Information

Responsible Party: Lynn Foster Reinke, Clinical Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01694628     History of Changes
Other Study ID Numbers: NPCRC Pilot Grant
First Submitted: September 24, 2012
First Posted: September 27, 2012
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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