Trial Outcomes & Findings for CBT for Adherence and Depression in Diabetes (NCT NCT00564070)
NCT ID: NCT00564070
Last Updated: 2018-01-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
Measured at Month 4
Results posted on
2018-01-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
45
|
|
Overall Study
COMPLETED
|
30
|
38
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Worsening depression, referred to care
|
3
|
0
|
Baseline Characteristics
CBT for Adherence and Depression in Diabetes
Baseline characteristics by cohort
| Measure |
Enhanced Treatment as Usual
n=42 Participants
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.
|
CBT-AD
n=45 Participants
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.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.31 years
STANDARD_DEVIATION 7.41 • n=5 Participants
|
55.44 years
STANDARD_DEVIATION 8.72 • n=7 Participants
|
56.87 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Clinician-Rated Depression
|
23.31 units on a scale
STANDARD_DEVIATION 7.20 • n=5 Participants
|
25.60 units on a scale
STANDARD_DEVIATION 8.99 • n=7 Participants
|
24.46 units on a scale
STANDARD_DEVIATION 8.10 • n=5 Participants
|
|
HbA1C
|
8.74 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.41 • n=5 Participants
|
8.81 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.78 • n=7 Participants
|
8.78 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.60 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 4Medical 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 measures
| Measure |
Enhanced Treatment as Usual
n=42 Participants
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.
|
CBT-AD
n=45 Participants
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.
|
|---|---|---|
|
Glucose Monitoring Adherence at Acute Outcome
|
49.63 percentage of glucose monitoring goal
Standard Deviation 4.66
|
79.79 percentage of glucose monitoring goal
Standard Deviation 4.03
|
PRIMARY outcome
Timeframe: month 4Population: Participants in each study arm
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 measures
| Measure |
Enhanced Treatment as Usual
n=42 Participants
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.
|
CBT-AD
n=45 Participants
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.
|
|---|---|---|
|
Percent Medication Adherence Via MEMS
|
69.69 Percentage of pills taken
Standard Deviation 3.72
|
90.37 Percentage of pills taken
Standard Deviation 3.48
|
PRIMARY outcome
Timeframe: month 4Population: Participants in each arm
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 measures
| Measure |
Enhanced Treatment as Usual
n=42 Participants
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.
|
CBT-AD
n=45 Participants
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.
|
|---|---|---|
|
Clinician Rated Depression (MADRS) at the Acute Timepoint
|
20.66 units on a scale (MADRS)
Standard Deviation 1.52
|
14.22 units on a scale (MADRS)
Standard Deviation 1.45
|
PRIMARY outcome
Timeframe: Month 4Population: Participants in each study arm
Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression
Outcome measures
| Measure |
Enhanced Treatment as Usual
n=42 Participants
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.
|
CBT-AD
n=45 Participants
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.
|
|---|---|---|
|
Depression on the CGI at Acute Outcome
|
3.17 units on a scale - the CGI
Standard Deviation .20
|
2.44 units on a scale - the CGI
Standard Deviation .21
|
SECONDARY outcome
Timeframe: Month 4Population: HbA1c as assessed by blood analysis
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 measures
| Measure |
Enhanced Treatment as Usual
n=42 Participants
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.
|
CBT-AD
n=45 Participants
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.
|
|---|---|---|
|
Glucose Control
|
8.58 percentage of glycosylated hemoglobin
Standard Deviation .16
|
7.86 percentage of glycosylated hemoglobin
Standard Deviation .16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Aggregate of months 4,8,12This 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.
Outcome measures
| Measure |
Enhanced Treatment as Usual
n=42 Participants
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.
|
CBT-AD
n=45 Participants
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.
|
|---|---|---|
|
Glucose Monitoring During Followup.
|
47 percentage of glucose monitoring goal
Standard Error 5.5
|
69 percentage of glucose monitoring goal
Standard Error 4.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Aggregate across 4,8,12 monthsElectronic 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.
Outcome measures
| Measure |
Enhanced Treatment as Usual
n=29 Participants
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.
|
CBT-AD
n=37 Participants
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.
|
|---|---|---|
|
Percent Medication Adherence During Follow up
|
71 percentage of doses taken
Standard Error 4.5
|
87 percentage of doses taken
Standard Error 2.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Aggregate across 4,8,12 monthsIndependent (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.
Outcome measures
| Measure |
Enhanced Treatment as Usual
n=38 Participants
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.
|
CBT-AD
n=40 Participants
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.
|
|---|---|---|
|
Depression MADRS Over Follow up
|
18.1 Units on the MADRS scale
Standard Error 1.5
|
15.1 Units on the MADRS scale
Standard Error 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Aggregate 4,8,12 monthsClinical 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.
Outcome measures
| Measure |
Enhanced Treatment as Usual
n=38 Participants
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.
|
CBT-AD
n=42 Participants
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.
|
|---|---|---|
|
Depression CGI
|
2.9 Units on the CGI scle
Standard Error .21
|
2.5 Units on the CGI scle
Standard Error .21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Aggregate across 4,8,12 monthsPopulation: HbA1c as assessed by blood analysis
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.
Outcome measures
| Measure |
Enhanced Treatment as Usual
n=38 Participants
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.
|
CBT-AD
n=40 Participants
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.
|
|---|---|---|
|
Glucose Control Over Follow up
|
8.5 percentage of glycosylated hemoglobin
Standard Error 2.2
|
7.9 percentage of glycosylated hemoglobin
Standard Error .19
|
Adverse Events
Enhanced Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CBT-AD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Steven Safren
Behavioral Medicine Service, Massachusetts General Hospital
Phone: (305) 284-2818
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place