Status:
COMPLETED
Adjusting to Chronic Conditions Using Education Support and Skills
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Anxiety
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Medically ill patients with Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD) are at increased risk for developing symptoms of anxiety and depression and are among the le...
Eligibility Criteria
Inclusion
- Age 18+;
- Confirmation of CHF or COPD diagnosis according to medical chart review;
- Ongoing symptoms of functional limitations due to CHF (NYHA classification of II , III, or IV as obtained by telephone interview) or COPD (Score of 3 or greater on the Medical Research Council Dyspnoea Scale \[MRC\] as obtained by telephone interview);
- Eligible patients must have clinically significant symptoms of either anxiety and/or depression as measured using patient self report questionnaires. Clinical cutoff scores for depression will be based on the Beck Depression Inventory - Second Edition (scores of 14 or more) while anxiety cutoffs will be determined using the State-Trait Anxiety Inventory - trait subscale (score of 40 or greater);
- Eligible patients will be English-speaking, as this intervention has not yet been translated to any other language.
Exclusion
- History of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from standardized structured clinical interview);
- NYHA class I, or MRC levels 1 and 2. Class 1 CHF patients and Level 1 and 2 COPD patients (by definition) will have no significantly limiting CHF or COPD symptoms. This information will be obtained through patient self-report of CHF and COPD symptoms;
- Mental status examination score in the cognitively impaired range on an established 6-item screen;
- Inability to provide informed consent or severe physical limitations restricting completion of the study protocol (e.g. vision, hearing, or physical functioning);
- Non-English speaking patients will be excluded from participation, as this intervention has not yet been translated to any other language.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00727155
Start Date
September 1 2008
End Date
March 1 2009
Last Update
July 10 2009
Active Locations (1)
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1
Houston VA Medical Center
Houston, Texas, United States, 77030