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Adjusting to Chronic Conditions Using Education Support and Skills (ACCESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727155
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : July 10, 2009
Information provided by:
VA Office of Research and Development

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 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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Adjusting to Chronic Conditions Using Education Support and Skills Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Quality Of Life For Chronically Ill Patients Using Education Support And Skills; A Randomized Controlled Mental Trial
Study Start Date : September 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 1
Behavioral: Adjusting to Chronic Conditions Using Education Support and Skills
This psychosocial intervention uses a combination of cognitive-behavioral therapy and disease self-management techniques.

No Intervention: 2

Primary Outcome Measures :
  1. Beck Depression Inventory, State Trait Anxiety Inventory, SF-36 Health Survey [ Time Frame: Weeks 1 (baseline), 2, 4, 6, 8, 12, 24, and 36 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00727155

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United States, Texas
Houston VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Jeffrey Cully, PhD MEd Michael E. DeBakey VA Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cully, Jeffrey - Principal Investigator, Department of Veterans Affairs Identifier: NCT00727155    
Other Study ID Numbers: H23264
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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Behavioral Symptoms