An interventional study of Enhanced treatment as usual plus adherence training and Enhanced treatment as usual plus CBT-AD in Diabetes Mellitus and Depression, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 87 is close to the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Enhanced treatment as usual plus single-session life-steps treatment
Behavioral: Enhanced treatment as usual plus adherence training
Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)
Behavioral: Enhanced treatment as usual plus CBT-AD
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.
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.
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
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
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
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
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
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
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
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
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
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
| Milestone | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Started | 42 | 45 |
| Completed | 30 | 38 |
| Not completed | 12 | 7 |
| Withdrew: Lost to follow-up | 9 | 7 |
| Withdrew: Worsening depression, referred to care | 3 | 0 |
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.
| percentage of glucose monitoring goal | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Glucose Monitoring Adherence at Acute Outcome | 49.63 ± 4.66 | 79.79 ± 4.03 |
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.
| percentage of glycosylated hemoglobin | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Glucose Control | 8.58 ± .16 | 7.86 ± .16 |
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
| Percentage of pills taken | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Percent Medication Adherence Via MEMS | 69.69 ± 3.72 | 90.37 ± 3.48 |
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.
| units on a scale (MADRS) | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Clinician Rated Depression (MADRS) at the Acute Timepoint | 20.66 ± 1.52 | 14.22 ± 1.45 |
Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression
| units on a scale - the CGI | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Depression on the CGI at Acute Outcome | 3.17 ± .20 | 2.44 ± .21 |
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.
| percentage of glucose monitoring goal | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Glucose Monitoring During Followup. | 47 ± 5.5 | 69 ± 4.2 |
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.
| percentage of doses taken | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Percent Medication Adherence During Follow up | 71 ± 4.5 | 87 ± 2.1 |
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.
| Units on the MADRS scale | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Depression MADRS Over Follow up | 18.1 ± 1.5 | 15.1 ± 1.5 |
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.
| Units on the CGI scle | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Depression CGI | 2.9 ± .21 | 2.5 ± .21 |
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.
| percentage of glycosylated hemoglobin | Enhanced Treatment as Usual | CBT-AD |
|---|---|---|
| Glucose Control Over Follow up | 8.5 ± 2.2 | 7.9 ± .19 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Treatment as Usual | — | 0/42 (0%) | 0/42 (0%) |
| CBT-AD | — | 0/45 (0%) | 0/45 (0%) |
| Age, Continuous(years) | Enhanced Treatment as Usual | CBT-AD | Total |
|---|---|---|---|
| Mean | 58.31 ± 7.41 | 55.44 ± 8.72 | 56.87 ± 8.07 |
| Sex: Female, Male(Participants) | Enhanced Treatment as Usual | CBT-AD | Total |
|---|---|---|---|
| Female | 20 | 23 | 43 |
| Male | 22 | 22 | 44 |
| Race (NIH/OMB)(Participants) | Enhanced Treatment as Usual | CBT-AD | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 7 |
| White | 34 | 38 | 72 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 1 | 4 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Enhanced Treatment as Usual | CBT-AD | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 39 | 45 | 84 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Clinician-Rated Depression(units on a scale) | Enhanced Treatment as Usual | CBT-AD | Total |
|---|---|---|---|
| Mean | 23.31 ± 7.20 | 25.60 ± 8.99 | 24.46 ± 8.10 |
| HbA1C(percentage of glycosylated hemoglobin) | Enhanced Treatment as Usual | CBT-AD | Total |
|---|---|---|---|
| Mean | 8.74 ± 1.41 | 8.81 ± 1.78 | 8.78 ± 1.60 |
The record gives a start of Jun 2007, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2018, 5 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital →