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| ID | Type | Description | Link |
|---|---|---|---|
| 2619 | Other Grant/Funding Number | HSR-D |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACCESS | Experimental | 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. |
|
| Enhanced Usual Care | No Intervention | Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACCESS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 month (post treatment), 8 month follow/up, and 12 month follow/up |
| 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. | 4 month (post treatment), 8 month follow/up, and 12 month follow/up |
| 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. | 4 month (post treatment), 8 month follow/up, 12 month follow/up |
| 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 | 4 month (post treatment), 8 month follow/up, 12 month follow/up |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Cully, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Oklahoma City | Oklahoma City | Oklahoma | 73104 | United States | ||
| Michael E. DeBakey VA Medical Center, Houston, TX |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24904701 | Result | 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. | |
| 23475245 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACCESS | 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 can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned. |
| FG001 | Enhanced Usual Care | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This is the total number of participants eligible after baseline and were randomized into each arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | ACCESS | 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. 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 minute. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 4 month (post treatment), 8 month follow/up, and 12 month follow/up |
|
Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study.
Although there were adverse events during the course of the study, none were determined to be related to the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACCESS | 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 completing 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. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Investigations | Non-systematic Assessment | These deaths were determined not to be related to the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Systematic Assessment | Patient eligibility was based on elevated symptoms of depression. Patients were monitored for significant increases in depression symptoms. No known adverse events were attributable to the study. |
There were some deaths and hospitalizations during the study, however, none of the adverse events reported were determined to be related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Cully | Michael E. DeBakey VA Medical Center | 713-794-8526 | Jeffrey.Cully@va.gov |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| 4 month (post treatment), 8 month follow/up, 12 month follow/up |
| 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. | 4 month (post treatment), 8 month follow/up, and 12 month follow/up |
| Houston |
| Texas |
| 77030 |
| United States |
| 22784436 | Result | 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. |
| Result | 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). |
| 24296739 | Result | 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. |
| 25622813 | Result | 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. |
| 30138022 | Derived | 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. |
| 29866141 | Derived | 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. |
| 29860524 | Derived | 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. |
| 28779469 | Derived | 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. |
| 28634906 | Derived | 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. |
| BG001 | Enhanced Usual Care | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patient Health Questionnaire (PHQ9) | The PHQ9 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. | Mean | Standard Deviation | units on a scale |
|
| 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); where higher scores = worse symptoms. | Mean | Standard Deviation | units on a scale |
|
| Chronic Respiratory Questionnaire_Mastery | The CRQ measures the quality of life of patients with a chronic respiratory disease. The subscale Mastery looks at the patients perceived control over the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health. | Mean | Standard Deviation | units on a scale |
|
| Chronic Respiratory Questionnaire_Dyspnea | The 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. | Mean | Standard Deviation | units on a scale |
|
| Chronic Respiratory Questionnaire_Fatigue | The 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Enhanced Usual Care | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 4 month (post treatment), 8 month follow/up, and 12 month follow/up |
|
|
|
| Primary | 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. | Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment. | Posted | Mean | Standard Deviation | units on a scale | 4 month (post treatment), 8 month follow/up, 12 month follow/up |
|
|
|
| Primary | 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 | Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment. | Posted | Mean | Standard Deviation | units on a scale | 4 month (post treatment), 8 month follow/up, 12 month follow/up |
|
|
|
| Primary | 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. | Only patients experiencing chronic lung problems (Chronic Obstructive Pulmonary Disease, emphysema, bronchitis, asthma) completed this assessment. | Posted | Mean | Standard Deviation | units on a scale | 4 month (post treatment), 8 month follow/up, 12 month follow/up |
|
|
|
| Primary | 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. | Only patients randomized for heart failure was required to complete the assessment. There were fewer patients randomized for congestive heart failure (CHF) as compared to COPD. | Posted | Mean | Standard Deviation | units on a scale | 4 month (post treatment), 8 month follow/up, and 12 month follow/up |
|
|
|
| 8 |
| 180 |
| 57 |
| 180 |
| EG001 | 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. | 9 | 122 | 52 | 122 |
|
| Hospitalizations | Cardiac disorders | Non-systematic Assessment | These adverse events were determined not to be related to the study. |
|
|
| Anxiety | Psychiatric disorders | Systematic Assessment | Patient eligibility was based on elevated symptoms of anxiety. Patients were monitored for significant increases in anxiety symptoms. No adverse events were known to be attributable to the study. |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| 12 Month |
|
| 12 month |
|
| 12 month |
|
| 12 month |
|
| 12 month |
|