Brief Summary
This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.
Brief Title
CBT for Adherence and Depression in 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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Diabetes Mellitus
Depression
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Depression
Diabetes
Adherence
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT00564070
Org Class
Other
Org Full Name
Massachusetts General Hospital
Org Study Id
R01MH078571
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
CBT for Adherence and Depression in Diabetes
Primary Outcomes
Outcome Description
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.
Outcome Measure
Glucose Monitoring Adherence at Acute Outcome
Outcome Time Frame
Measured at Month 4
Outcome Description
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
Outcome Measure
Percent Medication Adherence Via MEMS
Outcome Time Frame
month 4
Outcome Description
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.
Outcome Measure
Clinician Rated Depression (MADRS) at the Acute Timepoint
Outcome Time Frame
month 4
Outcome Description
Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression
Outcome Measure
Depression on the CGI at Acute Outcome
Outcome Time Frame
Month 4
Secondary Ids
Secondary Id
R01MH078571
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Month 4
Outcome Measure
Glucose Control
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jeffrey Gonzalez
Investigator Email
jeffrey.gonzalez@einsteinmed.org
Investigator Phone