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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH078571 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced treatment as usual | Active Comparator | Enhanced treatment as usual plus single-session life-steps treatment |
|
| CBT-AD | Experimental | Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced treatment as usual plus adherence training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at Month 4 |
| 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 | month 4 |
| 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. | month 4 |
| Depression on the CGI at Acute Outcome | Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Psaros, PhD | Partners HealthCare | Study Director |
| Steven Safren, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24170758 | Derived | Safren SA, Gonzalez JS, Wexler DJ, Psaros C, Delahanty LM, Blashill AJ, Margolina AI, Cagliero E. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes. Diabetes Care. 2014;37(3):625-33. doi: 10.2337/dc13-0816. Epub 2013 Oct 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of glucose monitoring goal | Measured at Month 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Safren | Behavioral Medicine Service, Massachusetts General Hospital | (305) 284-2818 | ssafren@miami.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003863 | Depression |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Enhanced treatment as usual plus CBT-AD | Behavioral | 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. |
|
| Aggregate of months 4,8,12 |
| 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. | Aggregate across 4,8,12 months |
| 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. | Aggregate across 4,8,12 months |
| 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. | Aggregate 4,8,12 months |
| 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. | Aggregate across 4,8,12 months |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Clinician-Rated Depression | 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. | Mean | Standard Deviation | units on a scale |
|
| HbA1C | 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. | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
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.
|
|
|
| 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. | HbA1c as assessed by blood analysis | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Month 4 |
|
|
|
|
| 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 | Participants in each study arm | Posted | Mean | Standard Deviation | Percentage of pills taken | month 4 |
|
|
|
|
| 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. | Participants in each arm | Posted | Mean | Standard Deviation | units on a scale (MADRS) | month 4 |
|
|
|
|
| Primary | Depression on the CGI at Acute Outcome | Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression | Participants in each study arm | Posted | Mean | Standard Deviation | units on a scale - the CGI | Month 4 |
|
|
|
|
| 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. | Posted | Mean | Standard Error | percentage of glucose monitoring goal | Aggregate of months 4,8,12 |
|
|
|
|
| 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. | Posted | Mean | Standard Error | percentage of doses taken | Aggregate across 4,8,12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Error | Units on the MADRS scale | Aggregate across 4,8,12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Error | Units on the CGI scle | Aggregate 4,8,12 months |
|
|
|
|
| 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. | HbA1c as assessed by blood analysis | Posted | Mean | Standard Error | percentage of glycosylated hemoglobin | Aggregate across 4,8,12 months |
|
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 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. | 0 | 45 | 0 | 45 |
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |