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

VA Office of Research and Development

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease; Depression; Heart Failure; Anxiety

Treatments: Behavioral: ACCESS

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01149772

2619 (Other Grant/Funding Number)

IIR 09-088

Details and patient eligibility

About

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 450 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.

Full 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.

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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302 participants in 2 patient groups

ACCESS

Experimental group

Description:

Medically ill patients received six-sessions of cognitive behavioral therapy tailored to their unique needs. Patients received 2 core modules and 3 elective modules. Elective modules focused on physical health, cognitive restructuring, behavioral activation, and relaxation. The six session was a wrap up that everyone received. Patients also had the option to receive 2 follow-up booster sessions to aid in maintenance of skills learned.

Treatment:

Behavioral: ACCESS

Enhanced Usual Care

No Intervention group

Description:

Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.