Cognitive Behavioral Therapy for COPD

Depression Clinical Trial

— CLIMB  

Official title:

Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694628
• Other study ID #: 43252
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Depression

Intervention

Behavioral:
• CLIMB (COPD Lifestyle, Mood, and Behavior)
Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms	Personal Health Questionnaire-9	8 weeks
Secondary	Dyspnea Intensity and Distress	Chronic Respiratory Questionnaire, Shortness of Breath Questionnaire, Dyspnea Management Questionnaire	8 weeks
Secondary	Fatigue	Chronic Respiratory Questionnaire	8 weeks
Secondary	Anxiety	Hospital Anxiety and Depression Scale	8 weeks
Secondary	Physical Activity	Accelerometry (Stepwatch)	8 weeks
Secondary	Quality of Life	Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36	8 weeks