CBT for Adherence and Depression in Diabetes

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00564070
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 87
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Depression	Behavioral: Enhanced treatment as usual plus adherence training; Behavioral: Enhanced treatment as usual plus CBT-AD	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: CBT for Adherence and Depression in Diabetes
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Enhanced treatment as usual Enhanced treatment as usual plus single-session life-steps treatment	Behavioral: 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.
Experimental: CBT-AD Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

3. 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.

4. 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

Secondary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• National Institute of Mental Health (NIMH)

Investigators

• Study Director: Christina Psaros, PhD, Partners HealthCare
• Principal Investigator: Steven Safren, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00564070
• Other Study ID Numbers: R01MH078571; R01MH078571
• First Posted: Nov 27, 2007
• Last Update Posted: Jan 8, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital: Depression; Diabetes; Adherence
• Additional relevant MeSH terms: Diabetes Mellitus; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	42	45
COMPLETED	30	38
NOT COMPLETED	12	7

Baseline Characteristics

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	42	45	87
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.31 (7.41)	55.44 (8.72)	56.87 (8.07)
Sex: Female, Male (Count of Participants)
Female	20 47.6%	23 51.1%	43 49.4%
Male	22 52.4%	22 48.9%	44 50.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2.4%	0 0%	1 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 9.5%	3 6.7%	7 8%
White	34 81%	38 84.4%	72 82.8%
More than one race	2 4.8%	0 0%	2 2.3%
Unknown or Not Reported	1 2.4%	4 8.9%	5 5.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 7.1%	0 0%	3 3.4%
Not Hispanic or Latino	39 92.9%	45 100%	84 96.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Clinician-Rated Depression (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	23.31 (7.20)	25.60 (8.99)	24.46 (8.10)
HbA1C (percentage of glycosylated hemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	8.74 (1.41)	8.81 (1.78)	8.78 (1.60)

Outcome Measures

1. Primary Outcome

Title	Glucose Monitoring Adherence at Acute 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.
Time Frame	Measured at Month 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	42	45
Mean (Standard Deviation) [percentage of glucose monitoring goal]	49.63 (4.66)	79.79 (4.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments	Multiple imputation was used to handle missing data; analyses are reported for the acute outcomes of glucose monitoring (i.e., 4 month)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Mixed Models Analysis
	Comments	General linear model, controlling for baseline values
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	30.2
	Confidence Interval	(2-Sided) 95%; 17.37 to 42.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The Mean Difference was calculated as percent adherence to glucose monitoring for the CBT-AD Arm minus the adherence to glucose monitoring for the Enhanced Treatment as Usual Arm.

2. Secondary Outcome

Title	Glucose Control
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.
Time Frame	Month 4

Outcome Measure Data

Analysis Population Description

HbA1c as assessed by blood analysis

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	42	45
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	8.58 (.16)	7.86 (.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments	Multiple imputation was used to handle missing data; results are reported for HbA1c at the acute outcome (i.e., 4 months)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.001
	Comments
	Method	ANCOVA
	Comments	General linear model; Controlling for baseline values
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.72
	Confidence Interval	(2-Sided) 95%; .29 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	The Mean Difference was calculated as percent of HbA1c for the Enhanced Treatment as Usual Arm minus percent of HbA1c for the CBT-AD Arm.

3. Primary Outcome

Title	Percent Medication Adherence Via MEMS
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
Time Frame	month 4

Outcome Measure Data

Analysis Population Description

Participants in each study arm

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	42	45
Mean (Standard Deviation) [Percentage of pills taken]	69.69 (3.72)	90.37 (3.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments	Analyses are reported for the acute outcomes of MEMs monitoring (4 month). Higher percentages represent better adherence.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.7
	Confidence Interval	(2-Sided) 95%; 10.22 to 31.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	The Mean Difference was calculated as percent pill adherence via MEMs for the CBT-AD Arm minus the percent pill adherence for the Enhanced Treatment as Usual Arm.

4. Primary Outcome

Title	Clinician Rated Depression (MADRS) at the Acute Timepoint
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.
Time Frame	month 4

Outcome Measure Data

Analysis Population Description

Participants in each arm

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	42	45
Mean (Standard Deviation) [units on a scale (MADRS)]	20.66 (1.52)	14.22 (1.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments	Analyses are reported for the acute outcomes of depression as assessed on the MADRS at acute outcome.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.002
	Comments
	Method	Mixed Models Analysis
	Comments	General linear model, controlling for baseline values.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.22
	Confidence Interval	(2-Sided) 95%; 2.33 to 10.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	The Mean Difference was calculated as MADRS unit scale for the CBT-AD Arm minus the MADRS unit scale for the Enhanced Treatment as Usual Arm.

5. Primary Outcome

Title	Depression on the CGI at Acute Outcome
Description	Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression
Time Frame	Month 4

Outcome Measure Data

Analysis Population Description

Participants in each study arm

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	42	45
Mean (Standard Deviation) [units on a scale - the CGI]	3.17 (.20)	2.44 (.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.01
	Comments
	Method	ANCOVA
	Comments	using GLM
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.74
	Confidence Interval	(2-Sided) 95%; .16 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments	The Mean Difference was calculated as CGI unit scale for the Enhanced Treatment as Usual Arm minus the CGI unit scale for the CBT-AD Arm.

6. Other Pre-specified Outcome

Title	Glucose Monitoring During Followup.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	42	45
Mean (Standard Error) [percentage of glucose monitoring goal]	47 (5.5)	69 (4.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments	We hypothesized that differences in glucose monitoring adherence would continue to be superior in the CBT-AD condition compared to ETAU
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.002
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	22.3
	Confidence Interval	(2-Sided) 95%; 8.6 to 36.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.0
	Estimation Comments

7. Other Pre-specified Outcome

Title	Percent Medication Adherence During Follow up
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	29	37
Mean (Standard Error) [percentage of doses taken]	71 (4.5)	87 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments	We hypothesized that the CBT-AD condition would maintain higher medication adherence over follow up compared to ETAU
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.3
	Confidence Interval	(2-Sided) 95%; 6.5 to 26.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.0
	Estimation Comments

8. Other Pre-specified Outcome

Title	Depression MADRS Over Follow up
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	38	40
Mean (Standard Error) [Units on the MADRS scale]	18.1 (1.5)	15.1 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments	We hypothesized that the lower depression scores would remain in the CBT arm compared to ETAU over follow up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.16
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; -1.2 to 7.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments

9. Other Pre-specified Outcome

Title	Depression CGI
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	38	42
Mean (Standard Error) [Units on the CGI scle]	2.9 (.21)	2.5 (.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments	We hypothesized that depression scores would remain lower in the CBT-AD arm compared to the ETAU arm
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.10
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.48
	Confidence Interval	(2-Sided) 95%; -.1 to 1.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .29
	Estimation Comments

10. Other Pre-specified Outcome

Title	Glucose Control Over Follow up
Description	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

Outcome Measure Data

Analysis Population Description

HbA1c as assessed by blood analysis

Arm/Group Title	Enhanced Treatment as Usual	CBT-AD
Arm/Group Description	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.	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.
Measure Participants	38	40
Mean (Standard Error) [percentage of glycosylated hemoglobin]	8.5 (2.2)	7.9 (.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced Treatment as Usual, CBT-AD
	Comments	We hypothesized that glucose control (HbA1C) would remain superior in the CBT-AD arm compared to the ETAU arm over follow up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.03
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.63
	Confidence Interval	(2-Sided) 95%; .6 to 1.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .29
	Estimation Comments

Adverse Events

Arm/Group Title	Enhanced Treatment as Usual		CBT-AD
Arm/Group Description	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.		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.
All Cause Mortality
	Enhanced Treatment as Usual		CBT-AD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Enhanced Treatment as Usual		CBT-AD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Enhanced Treatment as Usual		CBT-AD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.