CLIMB: Cognitive Behavioral Therapy for COPD

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT01694628
Collaborator
Icahn School of Medicine at Mount Sinai (Other)
18
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2
49
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior)
N/A

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
Actual Enrollment :
18 participants
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
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Depressive Symptoms [8 weeks]

    Personal Health Questionnaire-9

Secondary Outcome Measures

  1. Dyspnea Intensity and Distress [8 weeks]

    Chronic Respiratory Questionnaire, Shortness of Breath Questionnaire, Dyspnea Management Questionnaire

  2. Fatigue [8 weeks]

    Chronic Respiratory Questionnaire

  3. Anxiety [8 weeks]

    Hospital Anxiety and Depression Scale

  4. Physical Activity [8 weeks]

    Accelerometry (Stepwatch)

  5. Quality of Life [8 weeks]

    Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lynn Foster Reinke, Clinical Associate Professor, University of Washington
ClinicalTrials.gov Identifier:
NCT01694628
Other Study ID Numbers:
  • 43252
First Posted:
Sep 27, 2012
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021