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OpenTrials
Completed

NCT Number: NCT01694628

Cognitive Behavioral Therapy for COPD

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CLIMB (COPD Lifestyle, Mood, and Behavior)

Behavioral

Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.

Primary outcomes

  1. Depressive Symptoms

    Time frame: 8 weeks

    Personal Health Questionnaire-9

Secondary outcomes

  1. Dyspnea Intensity and Distress

    Time frame: 8 weeks

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

  2. Fatigue

    Time frame: 8 weeks

    Chronic Respiratory Questionnaire

  3. Anxiety

    Time frame: 8 weeks

    Hospital Anxiety and Depression Scale

  4. Physical Activity

    Time frame: 8 weeks

    Accelerometry (Stepwatch)

  5. Quality of Life

    Time frame: 8 weeks

    Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression

Acronym: CLIMB

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Sep 27, 2012
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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