Expired Study
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Houston, Texas 77030


Purpose:

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 least frequent users of mental health services and treatments. To address the needs of chronically ill patients, we created a time-limited psychosocial intervention to maximize treatment benefits and improve the efficiency and ability of mental health care practitioners to provide services within medical care settings. This study is separated into two randomized study groups. The first group of participants will receive the ACCESS intervention immediately. The second group of participants will be followed for a period of 6 months. After a period of 6 months, those who continue to have symptoms of depression and/or anxiety will be offered the ACCESS intervention.


Criteria:

Inclusion Criteria: 1. Age 18+; 2. Confirmation of CHF or COPD diagnosis according to medical chart review; 3. 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); 4. 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); 5. Eligible patients will be English-speaking, as this intervention has not yet been translated to any other language. Exclusion Criteria: 1. History of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from standardized structured clinical interview); 2. 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; 3. Mental status examination score in the cognitively impaired range on an established 6-item screen; 4. Inability to provide informed consent or severe physical limitations restricting completion of the study protocol (e.g. vision, hearing, or physical functioning); 5. Non-English speaking patients will be excluded from participation, as this intervention has not yet been translated to any other language.


Study is Available At:


Original ID:

H23264


NCT ID:

NCT00727155


Secondary ID:


Study Acronym:

ACCESS


Brief Title:

Adjusting to Chronic Conditions Using Education Support and Skills


Official Title:

Improving Quality Of Life For Chronically Ill Patients Using Education Support And Skills; A Randomized Controlled Mental Trial


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

3


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jeffrey Cully, PhD MEd
Principal Investigator
Houston VA Medical Center

Study Dates

Start Date:September 2008
Completion Date:March 2009
Completion Type:Actual
Primary Completion Date:March 2009
Primary Completion Type:Actual
Verification Date:July 2009
Last Changed Date:July 9, 2009
First Received Date:July 29, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Beck Depression Inventory, State Trait Anxiety Inventory, SF-36 Health Survey
Time Frame:Weeks 1 (baseline), 2, 4, 6, 8, 12, 24, and 36
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Adjusting to Chronic Conditions Using Education Su
Description:This psychosocial intervention uses a combination of cognitive-behavioral therapy and disease self-management techniques.
Arm Name:1

Study Arms

Study Arm Type:No Intervention
Arm Name:2
Description:Waitlist
Study Arm Type:Experimental
Arm Name:1
Description:Treatment

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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