Chronic Obstructive Pulmonary Disease, Heart Failure, Anxiety, Depression
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Heart Failure, Anxiety, Depression
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.
Interventions
BEHAVIORALACCESS
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire -9 (PHQ-9) | 4 month (post treatment), 8 month follow/up, and 12 month follow/up | 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) | 4 month (post treatment), 8 month follow/up, and 12 month follow/up | 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 | 4 month (post treatment), 8 month follow/up, 12 month follow/up | 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 | 4 month (post treatment), 8 month follow/up, 12 month follow/up | 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 | 4 month (post treatment), 8 month follow/up, 12 month follow/up | 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) | 4 month (post treatment), 8 month follow/up, and 12 month follow/up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 180 |
| Enhanced Usual Care Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. | 122 |
| Total | 302 |
Baseline characteristics
| Characteristic | ACCESS | Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 8.8 | 66.5 years STANDARD_DEVIATION 8.3 | 65.5 years STANDARD_DEVIATION 8.6 |
| Beck Anxiety Inventory (BAI) | 21.4 units on a scale STANDARD_DEVIATION 8.9 | 22.9 units on a scale STANDARD_DEVIATION 10.7 | 22.0 units on a scale STANDARD_DEVIATION 9.6 |
| Chronic Respiratory Questionnaire_Dyspnea | 3.05 units on a scale STANDARD_DEVIATION 0.95 | 2.90 units on a scale STANDARD_DEVIATION 1.03 | 2.99 units on a scale STANDARD_DEVIATION 0.98 |
| Chronic Respiratory Questionnaire_Fatigue | 2.63 units on a scale STANDARD_DEVIATION 0.9 | 2.43 units on a scale STANDARD_DEVIATION 0.97 | 2.55 units on a scale STANDARD_DEVIATION 0.93 |
| Chronic Respiratory Questionnaire_Mastery | 3.63 units on a scale STANDARD_DEVIATION 1.03 | 3.48 units on a scale STANDARD_DEVIATION 1.16 | 3.57 units on a scale STANDARD_DEVIATION 1.08 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | 36.93 units on a scale STANDARD_DEVIATION 14.94 | 37.03 units on a scale STANDARD_DEVIATION 19.36 | 36.97 units on a scale STANDARD_DEVIATION 16.81 |
| Patient Health Questionnaire (PHQ9) | 13.8 units on a scale STANDARD_DEVIATION 4.6 | 14.9 units on a scale STANDARD_DEVIATION 5 | 14.2 units on a scale STANDARD_DEVIATION 4.8 |
| Region of Enrollment United States | 180 participants | 122 participants | 302 participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 18 Participants |
| Sex: Female, Male Male | 168 Participants | 116 Participants | 284 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 57 / 180 | 52 / 122 |
| serious Total, serious adverse events | 8 / 180 | 9 / 122 |
Outcome results
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.
Time frame: 4 month (post treatment), 8 month follow/up, and 12 month follow/up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACCESS | Beck Anxiety Inventory (BAI) | 4 Month | 17.42 units on a scale | Standard Deviation 8.52 |
| ACCESS | Beck Anxiety Inventory (BAI) | 8 Month | 16.85 units on a scale | Standard Deviation 9.27 |
| ACCESS | Beck Anxiety Inventory (BAI) | 12 Month | 16.97 units on a scale | Standard Deviation 7.91 |
| Enhanced Usual Care | Beck Anxiety Inventory (BAI) | 12 Month | 21.19 units on a scale | Standard Deviation 11.4 |
| Enhanced Usual Care | Beck Anxiety Inventory (BAI) | 4 Month | 22.67 units on a scale | Standard Deviation 11.18 |
| Enhanced Usual Care | Beck Anxiety Inventory (BAI) | 8 Month | 21.59 units on a scale | Standard Deviation 11.41 |
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.
Time frame: 4 month (post treatment), 8 month follow/up, 12 month follow/up
Population: Only patients experiencing chronic lung problems (Chronic Obstructive Pulmonary Disease, emphysema, bronchitis, asthma) completed this assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACCESS | Chronic Respiratory Questionnaire_Dyspnea | 4 month | 3.37 units on a scale | Standard Deviation 1.15 |
| ACCESS | Chronic Respiratory Questionnaire_Dyspnea | 8 month | 3.27 units on a scale | Standard Deviation 1.02 |
| ACCESS | Chronic Respiratory Questionnaire_Dyspnea | 12 month | 3.07 units on a scale | Standard Deviation 0.99 |
| Enhanced Usual Care | Chronic Respiratory Questionnaire_Dyspnea | 4 month | 2.94 units on a scale | Standard Deviation 0.98 |
| Enhanced Usual Care | Chronic Respiratory Questionnaire_Dyspnea | 8 month | 3.03 units on a scale | Standard Deviation 0.89 |
| Enhanced Usual Care | Chronic Respiratory Questionnaire_Dyspnea | 12 month | 3.11 units on a scale | Standard Deviation 1.05 |
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.
Time frame: 4 month (post treatment), 8 month follow/up, 12 month follow/up
Population: Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACCESS | Chronic Respiratory Questionnaire_Fatigue | 4 month | 3.20 units on a scale | Standard Deviation 1.08 |
| ACCESS | Chronic Respiratory Questionnaire_Fatigue | 8 month | 3.11 units on a scale | Standard Deviation 1.09 |
| ACCESS | Chronic Respiratory Questionnaire_Fatigue | 12 month | 3.05 units on a scale | Standard Deviation 1.06 |
| Enhanced Usual Care | Chronic Respiratory Questionnaire_Fatigue | 4 month | 2.58 units on a scale | Standard Deviation 1.08 |
| Enhanced Usual Care | Chronic Respiratory Questionnaire_Fatigue | 8 month | 2.68 units on a scale | Standard Deviation 1.01 |
| Enhanced Usual Care | Chronic Respiratory Questionnaire_Fatigue | 12 month | 2.77 units on a scale | Standard Deviation 1.15 |
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
Time frame: 4 month (post treatment), 8 month follow/up, 12 month follow/up
Population: Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACCESS | Chronic Respiratory Questionnaire_Mastery | 4 month | 4.25 units on a scale | Standard Deviation 1.14 |
| ACCESS | Chronic Respiratory Questionnaire_Mastery | 8 month | 4.20 units on a scale | Standard Deviation 1.2 |
| ACCESS | Chronic Respiratory Questionnaire_Mastery | 12 month | 3.96 units on a scale | Standard Deviation 1.11 |
| Enhanced Usual Care | Chronic Respiratory Questionnaire_Mastery | 4 month | 3.51 units on a scale | Standard Deviation 1.19 |
| Enhanced Usual Care | Chronic Respiratory Questionnaire_Mastery | 8 month | 3.45 units on a scale | Standard Deviation 1.22 |
| Enhanced Usual Care | Chronic Respiratory Questionnaire_Mastery | 12 month | 3.62 units on a scale | Standard Deviation 1.28 |
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.
Time frame: 4 month (post treatment), 8 month follow/up, and 12 month follow/up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACCESS | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 4 month | 40.25 units on a scale | Standard Deviation 15.12 |
| ACCESS | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 8 month | 41.34 units on a scale | Standard Deviation 19.89 |
| ACCESS | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 12 month | 42.89 units on a scale | Standard Deviation 18.3 |
| Enhanced Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 4 month | 41.81 units on a scale | Standard Deviation 19.21 |
| Enhanced Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 8 month | 36.23 units on a scale | Standard Deviation 18.21 |
| Enhanced Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 12 month | 41.68 units on a scale | Standard Deviation 20.81 |
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.
Time frame: 4 month (post treatment), 8 month follow/up, and 12 month follow/up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACCESS | Patient Health Questionnaire -9 (PHQ-9) | 4 Month | 10.35 units on a scale | Standard Deviation 5.08 |
| ACCESS | Patient Health Questionnaire -9 (PHQ-9) | 8 Month | 10.32 units on a scale | Standard Deviation 5.48 |
| ACCESS | Patient Health Questionnaire -9 (PHQ-9) | 12 Month | 10.59 units on a scale | Standard Deviation 5.07 |
| Enhanced Usual Care | Patient Health Questionnaire -9 (PHQ-9) | 4 Month | 13.28 units on a scale | Standard Deviation 5.82 |
| Enhanced Usual Care | Patient Health Questionnaire -9 (PHQ-9) | 8 Month | 13.49 units on a scale | Standard Deviation 6.05 |
| Enhanced Usual Care | Patient Health Questionnaire -9 (PHQ-9) | 12 Month | 13.22 units on a scale | Standard Deviation 6.38 |