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

This study has been completed.
Information provided by:
VA Office of Research and Development Identifier:
First received: July 29, 2008
Last updated: July 9, 2009
Last verified: July 2009
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 Intervention
Behavioral: Adjusting to Chronic Conditions Using Education Support and Skills

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

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

Enrollment: 3
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT00727155

United States, Texas
Houston VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Jeffrey Cully, PhD MEd VA Medical Center, Houston
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cully, Jeffrey - Principal Investigator, Department of Veterans Affairs Identifier: NCT00727155     History of Changes
Other Study ID Numbers: H23264
Study First Received: July 29, 2008
Last Updated: July 9, 2009 processed this record on May 22, 2017