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

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00727155
First received: July 29, 2008
Last updated: July 9, 2009
Last verified: July 2009
  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.


Condition Intervention
Anxiety
Depression
Behavioral: Adjusting to Chronic Conditions Using Education Support and Skills

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 Department of Veterans Affairs:

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 ] [ Designated as safety issue: No ]

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
Treatment
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
Waitlist

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727155

Locations
United States, Texas
Houston VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Jeffrey Cully, PhD MEd Houston VA Medical Center
  More Information

No publications provided

Responsible Party: Cully, Jeffrey - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00727155     History of Changes
Other Study ID Numbers: H23264
Study First Received: July 29, 2008
Last Updated: July 9, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014