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CBT for Adherence and Depression in Diabetes

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ClinicalTrials.gov Identifier: NCT00564070
Recruitment Status : Completed
First Posted : November 27, 2007
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital

November 23, 2007
November 27, 2007
August 4, 2014
January 8, 2018
January 8, 2018
June 2007
March 2012   (Final data collection date for primary outcome measure)
  • Glucose Monitoring Adherence at Acute Outcome [ Time Frame: 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.
  • Percent Medication Adherence Via MEMS [ Time Frame: 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
  • Clinician Rated Depression (MADRS) at the Acute Timepoint [ Time Frame: 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.
  • Depression on the CGI at Acute Outcome [ Time Frame: Month 4 ]
    Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression
Medical adherence (glucose monitoring and hypoglycemic medications) and depression severity [ Time Frame: Measured at Months 4, 8, and 12 ]
Complete list of historical versions of study NCT00564070 on ClinicalTrials.gov Archive Site
Glucose Control [ Time Frame: 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.
Biomedical outcomes (hemoglobin A1C and self-monitored blood glucose values) [ Time Frame: Measured at Months 4, 8, and 12 ]
  • Glucose Monitoring During Followup. [ Time Frame: 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.
  • Percent Medication Adherence During Follow up [ Time Frame: 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.
  • Depression MADRS Over Follow up [ Time Frame: 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.
  • Depression CGI [ Time Frame: 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.
  • Glucose Control Over Follow up [ Time Frame: 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.
Not Provided
 
CBT for Adherence and Depression in Diabetes
CBT for Adherence and Depression in Diabetes
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Depression
  • 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.
  • 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.
  • Active Comparator: Enhanced treatment as usual
    Enhanced treatment as usual plus single-session life-steps treatment
    Intervention: Behavioral: Enhanced treatment as usual plus adherence training
  • Experimental: CBT-AD
    Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)
    Intervention: Behavioral: Enhanced treatment as usual plus CBT-AD
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. Erratum in: Diabetes Care. 2016 Jun;39(6):1065.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
100
March 2012
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00564070
R01MH078571( U.S. NIH Grant/Contract )
R01MH078571 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Steven A. Safren, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Study Director: Christina Psaros, PhD Partners HealthCare
Principal Investigator: Steven Safren, PhD University of Miami
Massachusetts General Hospital
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP