ACCESS: Adjusting to Chronic Conditions Using Education, Support, and Skills
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Medical Center, Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
| 2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIR 09-088
- 2619
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | ACCESS | Enhanced Usual Care |
|---|---|---|
| Arm/Group Description | 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. | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. |
| Period Title: Overall Study | ||
| STARTED | 180 | 122 |
| COMPLETED | 132 | 101 |
| NOT COMPLETED | 48 | 21 |
Baseline Characteristics
| Arm/Group Title | ACCESS | Enhanced Usual Care | Total |
|---|---|---|---|
| Arm/Group Description | 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. | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. | Total of all reporting groups |
| Overall Participants | 180 | 122 | 302 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
64.9
(8.8)
|
66.5
(8.3)
|
65.5
(8.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
12
6.7%
|
6
4.9%
|
18
6%
|
| Male |
168
93.3%
|
116
95.1%
|
284
94%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
180
100%
|
122
100%
|
302
100%
|
| Patient Health Questionnaire (PHQ9) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
13.8
(4.6)
|
14.9
(5.0)
|
14.2
(4.8)
|
| Beck Anxiety Inventory (BAI) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
21.4
(8.9)
|
22.9
(10.7)
|
22.0
(9.6)
|
| Chronic Respiratory Questionnaire_Mastery (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.63
(1.03)
|
3.48
(1.16)
|
3.57
(1.08)
|
| Chronic Respiratory Questionnaire_Dyspnea (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.05
(.95)
|
2.90
(1.03)
|
2.99
(.98)
|
| Chronic Respiratory Questionnaire_Fatigue (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.63
(.90)
|
2.43
(.97)
|
2.55
(.93)
|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
36.93
(14.94)
|
37.03
(19.36)
|
36.97
(16.81)
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ACCESS | Enhanced Usual Care |
|---|---|---|
| Arm/Group Description | 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. | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. |
| Measure Participants | 132 | 101 |
| 4 Month |
10.35
(5.08)
|
13.28
(5.82)
|
| 8 Month |
10.32
(5.48)
|
13.49
(6.05)
|
| 12 Month |
10.59
(5.07)
|
13.22
(6.38)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ACCESS | Enhanced Usual Care |
|---|---|---|
| Arm/Group Description | 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. | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. |
| Measure Participants | 132 | 101 |
| 4 Month |
17.42
(8.52)
|
22.67
(11.18)
|
| 8 Month |
16.85
(9.27)
|
21.59
(11.41)
|
| 12 Month |
16.97
(7.91)
|
21.19
(11.40)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment. |
| Arm/Group Title | ACCESS | Enhanced Usual Care |
|---|---|---|
| Arm/Group Description | 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. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. |
| Measure Participants | 101 | 74 |
| 4 month |
3.20
(1.08)
|
2.58
(1.08)
|
| 8 month |
3.11
(1.09)
|
2.68
(1.01)
|
| 12 month |
3.05
(1.06)
|
2.77
(1.15)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment. |
| Arm/Group Title | ACCESS | Enhanced Usual Care |
|---|---|---|
| Arm/Group Description | 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. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. |
| Measure Participants | 101 | 74 |
| 4 month |
4.25
(1.14)
|
3.51
(1.19)
|
| 8 month |
4.20
(1.20)
|
3.45
(1.22)
|
| 12 month |
3.96
(1.11)
|
3.62
(1.28)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only patients experiencing chronic lung problems (Chronic Obstructive Pulmonary Disease, emphysema, bronchitis, asthma) completed this assessment. |
| Arm/Group Title | ACCESS | Enhanced Usual Care |
|---|---|---|
| Arm/Group Description | 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. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. | Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services. |
| Measure Participants | 101 | 74 |
| 4 month |
3.37
(1.15)
|
2.94
(.98)
|
| 8 month |
3.27
(1.02)
|
3.03
(.89)
|
| 12 month |
3.07
(.99)
|
3.11
(1.05)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | ACCESS | Enhanced Usual Care |
|---|---|---|
| Arm/Group Description | 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. | Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services. |
| Measure Participants | 46 | 40 |
| 4 month |
40.25
(15.12)
|
41.81
(19.21)
|
| 8 month |
41.34
(19.89)
|
36.23
(18.21)
|
| 12 month |
42.89
(18.30)
|
41.68
(20.81)
|
Adverse Events
| Time Frame | Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Although there were adverse events during the course of the study, none were determined to be related to the study. | |||
| Arm/Group Title | ACCESS | Enhanced Usual Care | ||
| Arm/Group Description | 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. | Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services. | ||
All Cause Mortality |
||||
| ACCESS | Enhanced Usual Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| ACCESS | Enhanced Usual Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/180 (4.4%) | 9/122 (7.4%) | ||
| Cardiac disorders | ||||
| Hospitalizations | 4/180 (2.2%) | 4/122 (3.3%) | ||
| Investigations | ||||
| Death | 4/180 (2.2%) | 5/122 (4.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| ACCESS | Enhanced Usual Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 57/180 (31.7%) | 52/122 (42.6%) | ||
| Psychiatric disorders | ||||
| Depression | 33/180 (18.3%) | 24/122 (19.7%) | ||
| Anxiety | 24/180 (13.3%) | 28/122 (23%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Jeffrey Cully |
|---|---|
| Organization | Michael E. DeBakey VA Medical Center |
| Phone | 713-794-8526 |
| Jeffrey.Cully@va.gov |
- IIR 09-088
- 2619