Depression, Diabetes Mellitus
Conditions
Keywords
Depression, Diabetes, Adherence
Brief summary
This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.
Detailed description
Depression is a serious illness that affects a person's mood, thoughts, and physical being. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Depression is highly comorbid, often occurring in the presence of one or more other disorders. Up to 15% to 20% of the time, people with diabetes are also depressed. Diabetes is a disease that interferes with the body's proper production and use of the hormone insulin, which is needed to convert food into the energy required to perform daily life activities. Self-care is a crucial component of diabetes treatment. However, symptoms of depression can interfere with behaviors necessary to carry out this care. Cognitive behavioral therapy (CBT) has shown success in treating people with depression, but the effect of CBT on self-care behaviors and depression of those with diabetes is not well known. This study will evaluate the effectiveness of CBT for medical adherence and depression (CBT-AD) in people with a depressive mood disorder and type 2 diabetes. Upon study entry, all participants will complete various assessments, including a psychiatric diagnostic interview, a series of paper questionnaires, neuropsychological testing, blood sample analysis, and blood sugar monitoring. Next, all participants will meet with a nutritionist and a nurse diabetes educator. The nutritionist will help set goals for eating, physical activity, weight, and blood glucose. The nurse diabetes educator will review diabetes medication history and blood glucose self-monitoring equipment. Participants will then be randomly placed in one of two counseling groups. One group will meet for a single session that will be devoted to diabetes medical adherence. The other group will attend 10 to12 individual CBT sessions for diabetes medical adherence and depression management. The CBT sessions will last 45 to 50 minutes and will require practice of coping skills outside the sessions. Participants receiving CBT will also complete weekly assessments of depression, self-care, and diabetes medical adherence. All participants will be asked to monitor a prescribed medication with a pill cap for the course of the study. At Month 2, participants in both groups will also meet again with the nutritionist to review original goals and adjust them as necessary. Most of the previous study assessments will be repeated at Months 4, 8, and 12. The neuropsychological testing will be repeated only at Month 12.
Interventions
BEHAVIORALEnhanced treatment as usual plus adherence training
The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management.
BEHAVIORALEnhanced treatment as usual plus CBT-AD
The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care.
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes that is poorly controlled despite treatment with an oral hypoglycemic, insulin, or both * Diagnosis of major depression or dysthymia, or current subclinical symptoms of depression in spite of prescription of an antidepressant * If on an antidepressant, oral hypoglycemic medication, or insulin, must have been on a stable dose for the preceding two months
Exclusion criteria
* Active untreated major mental illness (e.g., untreated psychosis), bipolar disorder, eating disorder, mental retardation, or dementia * Experiencing suicidal thoughts * History of or currently receiving CBT for depression * Uses an insulin pump
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Monitoring Adherence at Acute Outcome | Measured at Month 4 | Medical adherence is a percent via the electronic monitoring using glucometer. This is a percent with a possible range of 0-100, with higher scores denoting better adherence. |
| Depression on the CGI at Acute Outcome | Month 4 | Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression |
| Clinician Rated Depression (MADRS) at the Acute Timepoint | month 4 | Depression as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). This scale has a range of 0-60 with higher scores indicating greater depression severity. |
| Percent Medication Adherence Via MEMS | month 4 | This is an electronic pill cap at the acute outcome assessment. This is a percent with a possible range of 0-100, higher scores indicating greater adherence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Control | Month 4 | Hemoglobin A1C value at acute outcome. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glucose Monitoring During Followup. | Aggregate of months 4,8,12 | This is a percent with a possible range of 0-100 with higher scores indicating better adherence. One Touch Ultra meters (LifeScan, Inc.) for daily glucose control provided frequency of self-monitoring, which when divided by the individualized goals from the nurse visits and multiplied by 100, yielded a percentage adherence score. This percentage adherence score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage adherence score for each arm throughout the course of the study. |
| Glucose Control Over Follow up | Aggregate across 4,8,12 months | Percent of HbA1c as assessed by blood analysis. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage. This percentage of HbA1c was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of HbA1c for each arm throughout the course of the study. |
| Depression CGI | Aggregate 4,8,12 months | Clinical Global Impression scale as rated by blinded interviewer. The CGI is a scale from 1-7 with greater numbers meaning more severe depression. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study. |
| Depression MADRS Over Follow up | Aggregate across 4,8,12 months | Independent (blind) assessor rating using the MADRS. This scale has a range of 0-60 with higher scores indicating greater depression severity. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study. |
| Percent Medication Adherence During Follow up | Aggregate across 4,8,12 months | Electronic pill cap adherence which indicates a percentage of doses taken. This percentage of doses taken was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of doses taken for each arm throughout the course of the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Treatment as Usual Enhanced treatment as usual plus single-session life-steps treatment
Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management. | 42 |
| CBT-AD Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)
Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care. | 45 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 7 |
| Overall Study | Worsening depression, referred to care | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|---|
| Age, Continuous | 56.87 years STANDARD_DEVIATION 8.07 | 58.31 years STANDARD_DEVIATION 7.41 | 55.44 years STANDARD_DEVIATION 8.72 |
| Clinician-Rated Depression | 24.46 units on a scale STANDARD_DEVIATION 8.1 | 23.31 units on a scale STANDARD_DEVIATION 7.2 | 25.60 units on a scale STANDARD_DEVIATION 8.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 39 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HbA1C | 8.78 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.6 | 8.74 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.41 | 8.81 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.78 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 72 Participants | 34 Participants | 38 Participants |
| Sex: Female, Male Female | 43 Participants | 20 Participants | 23 Participants |
| Sex: Female, Male Male | 44 Participants | 22 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 45 |
| serious Total, serious adverse events | 0 / 42 | 0 / 45 |
Outcome results
Primary
Clinician Rated Depression (MADRS) at the Acute Timepoint
Depression as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). This scale has a range of 0-60 with higher scores indicating greater depression severity.
Time frame: month 4
Population: Participants in each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Clinician Rated Depression (MADRS) at the Acute Timepoint | 20.66 units on a scale (MADRS) | Standard Deviation 1.52 |
| CBT-AD | Clinician Rated Depression (MADRS) at the Acute Timepoint | 14.22 units on a scale (MADRS) | Standard Deviation 1.45 |
Comparison: Analyses are reported for the acute outcomes of depression as assessed on the MADRS at acute outcome.p-value: =0.00295% CI: [2.33, 10.56]Mixed Models Analysis
Primary
Depression on the CGI at Acute Outcome
Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression
Time frame: Month 4
Population: Participants in each study arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Depression on the CGI at Acute Outcome | 3.17 units on a scale - the CGI | Standard Deviation 0.2 |
| CBT-AD | Depression on the CGI at Acute Outcome | 2.44 units on a scale - the CGI | Standard Deviation 0.21 |
p-value: =0.0195% CI: [0.16, 1.32]ANCOVA
Primary
Glucose Monitoring Adherence at Acute Outcome
Medical adherence is a percent via the electronic monitoring using glucometer. This is a percent with a possible range of 0-100, with higher scores denoting better adherence.
Time frame: Measured at Month 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Glucose Monitoring Adherence at Acute Outcome | 49.63 percentage of glucose monitoring goal | Standard Deviation 4.66 |
| CBT-AD | Glucose Monitoring Adherence at Acute Outcome | 79.79 percentage of glucose monitoring goal | Standard Deviation 4.03 |
Comparison: Multiple imputation was used to handle missing data; analyses are reported for the acute outcomes of glucose monitoring (i.e., 4 month)p-value: <0.000195% CI: [17.37, 42.9]Mixed Models Analysis
Primary
Percent Medication Adherence Via MEMS
This is an electronic pill cap at the acute outcome assessment. This is a percent with a possible range of 0-100, higher scores indicating greater adherence
Time frame: month 4
Population: Participants in each study arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Percent Medication Adherence Via MEMS | 69.69 Percentage of pills taken | Standard Deviation 3.72 |
| CBT-AD | Percent Medication Adherence Via MEMS | 90.37 Percentage of pills taken | Standard Deviation 3.48 |
Comparison: Analyses are reported for the acute outcomes of MEMs monitoring (4 month). Higher percentages represent better adherence.p-value: <0.000195% CI: [10.22, 31.14]Mixed Models Analysis
Secondary
Glucose Control
Hemoglobin A1C value at acute outcome. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage.
Time frame: Month 4
Population: HbA1c as assessed by blood analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Glucose Control | 8.58 percentage of glycosylated hemoglobin | Standard Deviation 0.16 |
| CBT-AD | Glucose Control | 7.86 percentage of glycosylated hemoglobin | Standard Deviation 0.16 |
Comparison: Multiple imputation was used to handle missing data; results are reported for HbA1c at the acute outcome (i.e., 4 months)p-value: =0.00195% CI: [0.29, 1.15]ANCOVA
Other Pre-specified
Depression CGI
Clinical Global Impression scale as rated by blinded interviewer. The CGI is a scale from 1-7 with greater numbers meaning more severe depression. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study.
Time frame: Aggregate 4,8,12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Depression CGI | 2.9 Units on the CGI scle | Standard Error 0.21 |
| CBT-AD | Depression CGI | 2.5 Units on the CGI scle | Standard Error 0.21 |
Comparison: We hypothesized that depression scores would remain lower in the CBT-AD arm compared to the ETAU armp-value: 0.195% CI: [-0.1, 1.1]Mixed Models Analysis
Other Pre-specified
Depression MADRS Over Follow up
Independent (blind) assessor rating using the MADRS. This scale has a range of 0-60 with higher scores indicating greater depression severity. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study.
Time frame: Aggregate across 4,8,12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Depression MADRS Over Follow up | 18.1 Units on the MADRS scale | Standard Error 1.5 |
| CBT-AD | Depression MADRS Over Follow up | 15.1 Units on the MADRS scale | Standard Error 1.5 |
Comparison: We hypothesized that the lower depression scores would remain in the CBT arm compared to ETAU over follow up.p-value: 0.1695% CI: [-1.2, 7.2]Mixed Models Analysis
Other Pre-specified
Glucose Control Over Follow up
Percent of HbA1c as assessed by blood analysis. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage. This percentage of HbA1c was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of HbA1c for each arm throughout the course of the study.
Time frame: Aggregate across 4,8,12 months
Population: HbA1c as assessed by blood analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Glucose Control Over Follow up | 8.5 percentage of glycosylated hemoglobin | Standard Error 2.2 |
| CBT-AD | Glucose Control Over Follow up | 7.9 percentage of glycosylated hemoglobin | Standard Error 0.19 |
Comparison: We hypothesized that glucose control (HbA1C) would remain superior in the CBT-AD arm compared to the ETAU arm over follow up.p-value: 0.0395% CI: [0.6, 1.2]Mixed Models Analysis
Other Pre-specified
Glucose Monitoring During Followup.
This is a percent with a possible range of 0-100 with higher scores indicating better adherence. One Touch Ultra meters (LifeScan, Inc.) for daily glucose control provided frequency of self-monitoring, which when divided by the individualized goals from the nurse visits and multiplied by 100, yielded a percentage adherence score. This percentage adherence score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage adherence score for each arm throughout the course of the study.
Time frame: Aggregate of months 4,8,12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Glucose Monitoring During Followup. | 47 percentage of glucose monitoring goal | Standard Error 5.5 |
| CBT-AD | Glucose Monitoring During Followup. | 69 percentage of glucose monitoring goal | Standard Error 4.2 |
Comparison: We hypothesized that differences in glucose monitoring adherence would continue to be superior in the CBT-AD condition compared to ETAUp-value: =0.00295% CI: [8.6, 36.1]Mixed Models Analysis
Other Pre-specified
Percent Medication Adherence During Follow up
Electronic pill cap adherence which indicates a percentage of doses taken. This percentage of doses taken was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of doses taken for each arm throughout the course of the study.
Time frame: Aggregate across 4,8,12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual | Percent Medication Adherence During Follow up | 71 percentage of doses taken | Standard Error 4.5 |
| CBT-AD | Percent Medication Adherence During Follow up | 87 percentage of doses taken | Standard Error 2.1 |
Comparison: We hypothesized that the CBT-AD condition would maintain higher medication adherence over follow up compared to ETAUp-value: =0.00195% CI: [6.5, 26.1]Mixed Models Analysis