Depression, Diabetes
Conditions
Keywords
Behavioral health coaching, Diabetes, Emotional health
Brief summary
The purpose of this study is to determine if behavioral health coaching for rural veterans with diabetes and depression will improve self-management behaviors and lead to improvement in diabetes care outcomes (e.g., HA1C) and improvement in reported depressive symptoms.
Detailed description
The co-occurence of diabetes and depression is highly prevalent and has dramatic consequences for quality of life and health. Due to the complex interrelation between diabetes and depression, patients often experience both psychological and physiological difficulties. These comorbid problems demand focused interventions that blend physical and emotional health treatments with self-management strategies.Rural-dwelling veterans with diabetes and depression are typically treated in community-based outpatient clinics (CBOCs). Patients with diabetes in rural areas tend to have more problems controlling their blood sugar, blood pressure and cholesterol compared to urban patients; thereby increasing their risk of diabetic complications. Similarly, rural patients with depression have similar barriers to care that increase their risk of poorer health outcomes as well. Using behavioral health coaches (BHCs)to deliver telephone-mediated therapies may enhance the reach of treatments for co-occurring diabetes and depression. The implementation of such treatments requires the development and testing of therapeutic manuals and BHC training protocols to ensure standardization and effectiveness. The BHC intervention has been labeled Health Outcomes through Patient Empowerment (HOPE) and will be offered to eligible patients receiving care through MEDVAMC and its CBOCs. Preliminary data obtained through this pilot grant is to support a larger VA grant.
Interventions
BEHAVIORALBehavioral Health Coaching
Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
Sponsors
South Central VA Mental Illness Research, Education & Clinical Center
Michael E. DeBakey VA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes and Primary Care Physician intent to treat * Clinically significant symptoms of depression per self-report * HA1C average of 7.5 or greater in past 12 months AND no HA1C \< 7.0 in past 12 months.
Exclusion criteria
* Factors that render a telephone-based behavioral activation intervention inappropriate * Significant cognitive impairment * Meet criteria of bipolar, psychotic or substance abuse disorder * Serious medical issues; e.g., terminal cancer * Reports severe depression or suicidal ideation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PHQ-9 (Patient Health Questionnaire-9)Scores | Baseline, 3 months, and 6 months | The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated. |
| Change in Hemoglobin A1C | baseline, 3 months, and 6 months | Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated. |
Countries
United States
Participant flow
Recruitment details
The recruitment period lasted from January 2011 through July 2011. After patients were screened, recruitment occurred over the phone, where they gave audio consent to participate in the study.
Pre-assignment details
Three participants who gave consent to participate in the study met exclusion criteria at baseline and were removed from the study before being assigned to the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Health Coaching Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | After consent, met exclusion criteria. | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Behavioral Health Coaching |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 61.4 years STANDARD_DEVIATION 5.71 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Change in Hemoglobin A1C
Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.
Time frame: baseline, 3 months, and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Health Coaching | Change in Hemoglobin A1C | Change from baseline to 3 months | 1.13 percentage of glycated hemoglobin | Standard Deviation 1.7 |
| Behavioral Health Coaching | Change in Hemoglobin A1C | Change from baseline to 6 months | 0.84 percentage of glycated hemoglobin | Standard Deviation 1.62 |
Primary
Change in PHQ-9 (Patient Health Questionnaire-9)Scores
The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.
Time frame: Baseline, 3 months, and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Health Coaching | Change in PHQ-9 (Patient Health Questionnaire-9)Scores | Change from baseline to 3-month, M (SD) | 5.14 scores on a scale | Standard Deviation 2.27 |
| Behavioral Health Coaching | Change in PHQ-9 (Patient Health Questionnaire-9)Scores | Change from baseline to 6-month, M (SD) | 7.03 scores on a scale | Standard Deviation 4.43 |