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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01149772
First received: June 10, 2010
Last updated: April 25, 2014
Last verified: April 2014
  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 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.


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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: 450
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
Criteria

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
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: NCT01149772

Locations
United States, Oklahoma
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Jeffrey Cully, PhD MEd Michael E DeBakey VA Medical Center
  More Information

Publications:
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 25, 2014
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:
Anxiety Disorders
Depression
Depressive Disorder
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Mental Disorders
Behavioral Symptoms
Mood Disorders
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014