Depression, Diabetes-related Distress, Type 2 Diabetes Mellitus
Conditions
Brief summary
The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression.
Detailed description
The investigators plan to implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression. The investigators approach will combine practice-based medical and cognitive behavioral treatment with strong community-based support to immediately place the patient at the right level of intervention based on disease and severity and to step-up treatment intensity and follow-up if the initial response is inadequate. The practice-based component will use a care manager linked to medical, pharmacologic, and behavioral colleagues. The community based component will utilize community health workers to provide support and facilitate access to resources. Goals include: 1) implementing and evaluating the effectiveness of this intervention; 2) examining the impact of this approach on psychological mediators of improved glycosylated hemoglobin (HbA1c); and 3) building, sustaining, and disseminating a cost-effective care model.
Interventions
BEHAVIORALIntegrated Behavioral Care
Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Sponsors
Bristol-Myers Squibb
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical Diagnosis of Type 2 diabetes mellitus 2. Glycosylated Hemoglobin (HbA1c) \> 7.0 = Uncontrolled 3. Positive score on diabetes related distress 2 question screener and/or 4. Positive score on Patient Health Questionnaire (PHQ-2) 2 question screener
Exclusion criteria
a diagnosis \[from billing records using International Classification of Disease, 9th Edition (ICD-9) codes\] of: 1. advanced disease (e.g., end stage renal disease, advanced heart failure, blindness, metastatic cancer and including those who are in active treatment for cancer), or 2. alcoholism or 3. cognitive impairment, or 4. major psychiatric disease or 5. any type of physical or mental impairment that would preclude active participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (%) | Baseline to 12 months | Change from baseline in HbA1c or glycosylated hemoglobin (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Diabetes Regimen-Related Distress | Baseline to 12 months | Diabetes regimen-related distress is a measure of the emotional response to having and managing diabetes and is measured by a subscale of 5 items (#5, 6, 10, 12, 16) from the Diabetes-related Distress instrument (DDS-17). Each item is rated from 1 (not a problem) - 6 (very serious problem) and therefore the total score for this sub-score ranges from 5 - 30. The mean score for an individual can be computed as the sum of the 5 items divided by 5. For this study outcome, the investigators computed the average change (increase or decrease) in the mean RRD score from baseline to 12-mo. follow-up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Self-care Activities | Baseline to 12 months | Diabetes self-care activities as measured by the Self-reported Diabetes Self Care Activities (SDSCA) instrument. The SDSCA is a questionnaire which assesses levels of self-care in adults with diabetes. The tool contains 11 items, which measure the frequency of performing diabetes self-care activities over the last seven days including diet, exercise, blood glucose testing, foot care and tobacco use. The respondent marks the number of days on which the indicated behavior was performed on an eight-point Likert scale (0 - 7) to answer the questions. The first ten items are summed to a total score. The eleventh item focuses on smoking habits and assesses the average number of cigarettes smoked per day. For the present study, the total score was summed and divided by 11 items to create a mean score and then the average change from baseline to 12 month follow-up. |
| Change in Depressive Symptoms | Baseline to 12 months | Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) instrument for depressive symptoms. Diagnosis based on Total PHQ-9 Score; Interpretation: Minimal depression 0-4 Mild depression 5-9 Moderate depression 10-14 Moderately severe depression 15-19 Severe depression 20-27 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Integrated Behavioral Intervention Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Integrated Behavioral Care: Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care. | 67 |
| Usual Care Patients receive usual care | 72 |
| Total | 139 |
Baseline characteristics
| Characteristic | Integrated Behavioral Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 52.67 years STANDARD_DEVIATION 9.67 | 54.71 years STANDARD_DEVIATION 9.3 | 53.7 years STANDARD_DEVIATION 9.5 |
| HbA1c | 9.8 percent STANDARD_DEVIATION 2.1 | 9.3 percent STANDARD_DEVIATION 1.7 | 9.6 percent STANDARD_DEVIATION 1.9 |
| Race/Ethnicity, Customized African American | 53 Participants | 48 Participants | 101 Participants |
| Race/Ethnicity, Customized White or mixed race | 14 Participants | 24 Participants | 38 Participants |
| Region of Enrollment United States | 67 Participants | 72 Participants | 139 Participants |
| Sex: Female, Male Female | 53 Participants | 55 Participants | 108 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 72 |
| other Total, other adverse events | 0 / 67 | 0 / 72 |
| serious Total, serious adverse events | 0 / 67 | 0 / 72 |
Outcome results
Primary
Change From Baseline in Glycosylated Hemoglobin (%)
Change from baseline in HbA1c or glycosylated hemoglobin (%)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Behavioral Intervention | Change From Baseline in Glycosylated Hemoglobin (%) | -0.92 change from baseline in A1c (%) | Standard Deviation 1.8 |
| Usual Care | Change From Baseline in Glycosylated Hemoglobin (%) | -0.31 change from baseline in A1c (%) | Standard Deviation 2 |
Secondary
Change From Baseline in Diabetes Regimen-Related Distress
Diabetes regimen-related distress is a measure of the emotional response to having and managing diabetes and is measured by a subscale of 5 items (#5, 6, 10, 12, 16) from the Diabetes-related Distress instrument (DDS-17). Each item is rated from 1 (not a problem) - 6 (very serious problem) and therefore the total score for this sub-score ranges from 5 - 30. The mean score for an individual can be computed as the sum of the 5 items divided by 5. For this study outcome, the investigators computed the average change (increase or decrease) in the mean RRD score from baseline to 12-mo. follow-up.
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Behavioral Intervention | Change From Baseline in Diabetes Regimen-Related Distress | -1.1 score on a scale | Standard Deviation 1 |
| Usual Care | Change From Baseline in Diabetes Regimen-Related Distress | -0.3 score on a scale | Standard Deviation 1.2 |
p-value: <0.0001t-test, 2 sided
Other Pre-specified
Change in Depressive Symptoms
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) instrument for depressive symptoms. Diagnosis based on Total PHQ-9 Score; Interpretation: Minimal depression 0-4 Mild depression 5-9 Moderate depression 10-14 Moderately severe depression 15-19 Severe depression 20-27
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Behavioral Intervention | Change in Depressive Symptoms | -3.4 score on a scale | Standard Deviation 5 |
| Usual Care | Change in Depressive Symptoms | -0.9 score on a scale | Standard Deviation 6.2 |
p-value: <0.01t-test, 2 sided
Other Pre-specified
Change in Diabetes Self-care Activities
Diabetes self-care activities as measured by the Self-reported Diabetes Self Care Activities (SDSCA) instrument. The SDSCA is a questionnaire which assesses levels of self-care in adults with diabetes. The tool contains 11 items, which measure the frequency of performing diabetes self-care activities over the last seven days including diet, exercise, blood glucose testing, foot care and tobacco use. The respondent marks the number of days on which the indicated behavior was performed on an eight-point Likert scale (0 - 7) to answer the questions. The first ten items are summed to a total score. The eleventh item focuses on smoking habits and assesses the average number of cigarettes smoked per day. For the present study, the total score was summed and divided by 11 items to create a mean score and then the average change from baseline to 12 month follow-up.
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Behavioral Intervention | Change in Diabetes Self-care Activities | 1.1 score on a scale | Standard Deviation 1.3 |
| Usual Care | Change in Diabetes Self-care Activities | 0.58 score on a scale | Standard Deviation 1.4 |
p-value: <0.03t-test, 2 sided