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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01149772
First received: June 10, 2010
Last updated: January 25, 2016
Last verified: January 2016
  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: ACCESS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
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 VA Office of Research and Development:

Primary Outcome Measures:
  • Patient Health Questionnaire -9 (PHQ-9) [ Time Frame: 4 month (post treatment), 8 month follow/up, and 12 month follow/up ] [ Designated as safety issue: No ]
    The PHQ-9 measures an individual's level of depression. The measure is summed and ranges from 0 - 27 (individual item score range 0 - 3 per 9 items); where higher scores = worse symptoms.

  • Beck Anxiety Inventory (BAI) [ Time Frame: 4 month (post treatment), 8 month follow/up, and 12 month follow/up ] [ Designated as safety issue: No ]
    The BAI measures an individual's level of anxiety. The measure is summed and ranges from 0 - 63 (individual item score range 0 -3 per 21 items); were higher scores = worse symptoms.

  • Chronic Respiratory Questionnaire_Fatigue [ Time Frame: 4 month (post treatment), 8 month follow/up, 12 month follow/up ] [ Designated as safety issue: No ]
    The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. This subscale measures the amount of fatigue patients experience with the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.

  • Chronic Respiratory Questionnaire_Mastery [ Time Frame: 4 month (post treatment), 8 month follow/up, 12 month follow/up ] [ Designated as safety issue: No ]
    The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Mastery looks at the patient's perceived control over the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health

  • Chronic Respiratory Questionnaire_Dyspnea [ Time Frame: 4 month (post treatment), 8 month follow/up, 12 month follow/up ] [ Designated as safety issue: No ]
    The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Dyspnea looks at how much shortness of breath a patient experiences. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.

  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 4 month (post treatment), 8 month follow/up, and 12 month follow/up ] [ Designated as safety issue: No ]
    The KCCQ measures the health status of patients with congestive heart failure. The overall score is a mean score scaled from 0 - 100; where 0 represents most severe/limited functioning.


Enrollment: 302
Study Start Date: February 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACCESS
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.
Behavioral: ACCESS
Participants received 6 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 was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. Participants also had the option to receive 2 brief follow-up booster calls to aid in reinforcing the changes made.
No Intervention: Enhanced Usual Care
Patients in this arm received feedback about their physical and emotional health functioning and were still able to 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, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jeffrey Cully, PhD Michael E. DeBakey VA Medical Center, Houston, TX
  More Information

Publications:
Mignogna J, Cully J. Depression and Anxiety in Patients with COPD: A Focus on Psychological Treatments in Ambulatory Care Settings. Current respiratory medicine reviews. 2012 Apr 1; 8(2):137-144(8).

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01149772     History of Changes
Other Study ID Numbers: IIR 09-088  2619 
Study First Received: June 10, 2010
Results First Received: October 13, 2015
Last Updated: January 25, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Chronic Obstructive Pulmonary Disease
Heart Failure
Anxiety
Depression

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cardiovascular Diseases
Heart Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 02, 2016