search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Heart Failure, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACCESS
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Heart Failure, Anxiety, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • VA Medical Center, Oklahoma City
  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ACCESS

Enhanced Usual Care

Arm 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.

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

Outcomes

Primary Outcome Measures

Patient Health Questionnaire -9 (PHQ-9)
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)
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
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
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
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)
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.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2010
Last Updated
January 25, 2016
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT01149772
Brief Title
Adjusting to Chronic Conditions Using Education, Support, and Skills
Acronym
ACCESS
Official Title
Cognitive Behavioral Therapy in Primary Care: Treating the Medically Ill
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Heart Failure, Anxiety, Depression
Keywords
Chronic Obstructive Pulmonary Disease, Heart Failure, Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACCESS
Arm Type
Experimental
Arm 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.
Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
Intervention Type
Behavioral
Intervention Name(s)
ACCESS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire -9 (PHQ-9)
Description
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.
Time Frame
4 month (post treatment), 8 month follow/up, and 12 month follow/up
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
4 month (post treatment), 8 month follow/up, and 12 month follow/up
Title
Chronic Respiratory Questionnaire_Fatigue
Description
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.
Time Frame
4 month (post treatment), 8 month follow/up, 12 month follow/up
Title
Chronic Respiratory Questionnaire_Mastery
Description
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
Time Frame
4 month (post treatment), 8 month follow/up, 12 month follow/up
Title
Chronic Respiratory Questionnaire_Dyspnea
Description
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.
Time Frame
4 month (post treatment), 8 month follow/up, 12 month follow/up
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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.
Time Frame
4 month (post treatment), 8 month follow/up, and 12 month follow/up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Cully, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24904701
Citation
Mignogna J, Hundt NE, Kauth MR, Kunik ME, Sorocco KH, Naik AD, Stanley MA, York KM, Cully JA. Implementing brief cognitive behavioral therapy in primary care: A pilot study. Transl Behav Med. 2014 Jun;4(2):175-83. doi: 10.1007/s13142-013-0248-6.
Results Reference
result
PubMed Identifier
23475245
Citation
Cully JA, Curry AD, Ryan SR, Malik A, Zeno D, Willcockson IU. Development of a computer-aided training program for brief cognitive-behavioral therapy in primary care. Acad Psychiatry. 2013 Mar 1;37(2):120-4. doi: 10.1176/appi.ap.11040078. No abstract available.
Results Reference
result
PubMed Identifier
22784436
Citation
Cully JA, Armento ME, Mott J, Nadorff MR, Naik AD, Stanley MA, Sorocco KH, Kunik ME, Petersen NJ, Kauth MR. Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design. Implement Sci. 2012 Jul 11;7:64. doi: 10.1186/1748-5908-7-64.
Results Reference
result
Citation
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).
Results Reference
result
PubMed Identifier
24296739
Citation
Hundt NE, Bensadon BA, Stanley MA, Petersen NJ, Kunik ME, Kauth MR, Cully JA. Coping mediates the relationship between disease severity and illness intrusiveness among chronically ill patients. J Health Psychol. 2015 Sep;20(9):1186-95. doi: 10.1177/1359105313509845. Epub 2013 Dec 1.
Results Reference
result
PubMed Identifier
25622813
Citation
Breland JY, Hundt NE, Barrera TL, Mignogna J, Petersen NJ, Stanley MA, Cully JA. Identification of Anxiety Symptom Clusters in Patients with COPD: Implications for Assessment and Treatment. Int J Behav Med. 2015 Oct;22(5):590-6. doi: 10.1007/s12529-014-9450-2.
Results Reference
result
PubMed Identifier
30138022
Citation
Hundt NE, Renn BN, Sansgiry S, Petersen NJ, Stanley MA, Kauth MR, Naik AD, Kunik ME, Cully JA. Predictors of response to brief CBT in patients with cardiopulmonary conditions. Health Psychol. 2018 Sep;37(9):866-873. doi: 10.1037/hea0000595.
Results Reference
derived
PubMed Identifier
29866141
Citation
Mignogna J, Martin LA, Harik J, Hundt NE, Kauth M, Naik AD, Sorocco K, Benzer J, Cully J. "I had to somehow still be flexible": exploring adaptations during implementation of brief cognitive behavioral therapy in primary care. Implement Sci. 2018 Jun 5;13(1):76. doi: 10.1186/s13012-018-0768-z.
Results Reference
derived
PubMed Identifier
29860524
Citation
Renn BN, Hundt NE, Sansgiry S, Petersen NJ, Kauth MR, Kunik ME, Cully JA. Integrated Brief Cognitive Behavioral Therapy Improves Illness Intrusiveness in Veterans With Chronic Obstructive Pulmonary Disease. Ann Behav Med. 2018 Jul 13;52(8):686-696. doi: 10.1093/abm/kax045.
Results Reference
derived
PubMed Identifier
28779469
Citation
Thakur ER, Sansgiry S, Petersen NJ, Stanley M, Kunik ME, Naik AD, Cully JA. Cognitive and Perceptual Factors, Not Disease Severity, Are Linked with Anxiety in COPD: Results from a Cross-Sectional Study. Int J Behav Med. 2018 Feb;25(1):74-84. doi: 10.1007/s12529-017-9663-2.
Results Reference
derived
PubMed Identifier
28634906
Citation
Cully JA, Stanley MA, Petersen NJ, Hundt NE, Kauth MR, Naik AD, Sorocco K, Sansgiry S, Zeno D, Kunik ME. Delivery of Brief Cognitive Behavioral Therapy for Medically Ill Patients in Primary Care: A Pragmatic Randomized Clinical Trial. J Gen Intern Med. 2017 Sep;32(9):1014-1024. doi: 10.1007/s11606-017-4101-3. Epub 2017 Jun 20.
Results Reference
derived

Learn more about this trial

Adjusting to Chronic Conditions Using Education, Support, and Skills

We'll reach out to this number within 24 hrs