Adjusting to Chronic Conditions Using Education, Support, and Skills (ACCESS)
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Purpose
The current study seeks to test the effectiveness of a talk-therapy intervention designed to better meet the needs of chronically ill veterans. This project looks to recruit 420 veterans with either chronic obstructive pulmonary disease (COPD) or heart failure (HF) who also have symptoms of worry, stress, anxiety, or sadness. Participants will be randomly put into either the talk-therapy intervention or enhanced usual care.
The talk therapy intervention will be provided by VA clinicians in the primary care setting and will consist of 6 core meetings (30-45 minutes in duration) and 2 follow-up telephone meetings. Enhanced usual care participants will receive feedback regarding the assessment findings and educational materials on COPD and/or HF, depression and anxiety.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease Heart Failure 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: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cognitive Behavioral Therapy in Primary Care: Treating the Medically Ill |
- Measurement of dyspnea, fatigue, and emotional functioning in patients with COPD [ Time Frame: Baseline, 4 month (post treatment), 8 month F/U, and 12 month F/U ] [ Designated as safety issue: No ]
- Measurement of physical functioning, social function, self-efficacy and quality of life in patients with heart failure [ Time Frame: Baseline, 4 month (post treatment), 8 month F/U, and 12 month F/U ] [ Designated as safety issue: No ]
- Measurement of anxiety [ Time Frame: Baseline, 4 month (post treatment), 8 month F/U, and 12 month F/U ] [ Designated as safety issue: No ]
- Measurement of depression [ Time Frame: Baseline, 4 month (post treatment), 8 month F/U, and 12 month F/U ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 420 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Six-sessions of cognitive behavioral therapy tailored to the unique needs of the medically ill. Patients also receive 2 follow-up booster sessions.
|
Behavioral: Adjusting to Chronic Conditions Using Education, Support, and Skills
Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant will receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. Each active treatment session lasts 30 - 40 minutes and the booster calls last 10 - 15 minutes.
Other Name: ACCESS
|
|
No Intervention: Arm 2
Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
|
Detailed Description:
Diseases of the heart and circulatory system, namely, Chronic Obstructive Pulmonary Disease (COPD) and Heart Failure (HF), are two of the most common and disabling chronic diseases. Both COPD and HF account for significant disability, mortality, and healthcare costs and are associated with lower health status and more functional and social limitations than other chronic illnesses, such as hypertension and diabetes. As our population ages and life span increases, the numbers of patients with these conditions and the subsequent healthcare costs will increase dramatically.
The symptoms associated with COPD and HF can significantly affect daily functioning. Physical symptoms are often linked to increased levels of psychological distress, namely, anxiety and depression, which significantly affect quality of life and functioning above and beyond the impact of the medical disease. As depression and anxiety are modifiable clinical factors, there is a potential to significantly alter patient outcomes, as well as use of healthcare services. However, focused interventions are needed, given the high risk for poor mental health treatment and underuse of mental health services in persons with COPD and HF. Unfortunately, few intervention studies have been conducted in medically ill patients with these conditions. The current project will examine whether existing VA clinicians in the primary care setting, with training and support, can effectively administer a structured Cognitive Behavioral Therapy (CBT) intervention for depressed and anxious Veterans with COPD and HF.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- COPD and/or HF diagnosis; confirmation based upon medical chart review.
- clinically significant symptoms for anxiety and/or depression.
Exclusion Criteria:
- cognitive impairment
- presence of bipolar, psychotic or substance abuse disorder.
Contacts and Locations| Contact: Darrell Zeno, MS BS | (713) 794-8678 | darrell.zeno@va.gov |
| United States, Oklahoma | |
| VA Medical Center, Oklahoma City | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Joel Wendell, PhD 405-456-5890 Joel-Wendell@ouhsc.edu | |
| United States, Texas | |
| Michael E DeBakey VA Medical Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Darrell Zeno, MS BS (713) 794-8678 darrell.zeno@va.gov | |
| Sub-Investigator: Aanand Dinkar Naik, MD | |
| Principal Investigator: Jeffrey Cully, PhD MEd | |
| Sub-Investigator: Mark E. Kunik, MD MPH | |
| Sub-Investigator: Melinda A. Stanley, PhD | |
| Sub-Investigator: Michael Kauth, PhD | |
| Principal Investigator: | Jeffrey Cully, PhD MEd | Michael E DeBakey VA Medical Center |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01149772 History of Changes |
| Other Study ID Numbers: | IIR 09-088, 2619 |
| Study First Received: | June 10, 2010 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Chronic Obstructive Pulmonary Disease Heart Failure Anxiety Depression |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Anxiety Disorders Depression Depressive Disorder Lung Diseases Respiration Disorders |
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Mental Disorders Behavioral Symptoms Mood Disorders Cardiovascular Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013