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Effectiveness of Cognitive Behavioral Therapy in Improving Adherence and Depressive Symptoms in People With Diabetes
This study is currently recruiting participants.
Study NCT00564070   Information provided by National Institute of Mental Health (NIMH)
First Received: November 23, 2007   Last Updated: April 8, 2009   History of Changes

November 23, 2007
April 8, 2009
July 2007
June 2011   (final data collection date for primary outcome measure)
Medical adherence (glucose monitoring and hypoglycemic medications) and depression severity [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: No ]
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
Biomedical outcomes (hemoglobin A1C and self-monitored blood glucose values) [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: Yes ]
Biomedical outcomes (hemoglobin A1C and self-monitored blood glucose values) [ Time Frame: Measured at Months 4, 8, and 12 ]
 
Effectiveness of Cognitive Behavioral Therapy in Improving Adherence and Depressive Symptoms in People With 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 4 months during treatment. 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
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
  • Diabetes Mellitus
  • Depression
  • Behavioral: Enhanced treatment as usual plus adherence training
  • Behavioral: Enhanced treatment as usual plus CBT-AD
  • Active Comparator: Enhanced treatment as usual plus single-session life-steps treatment
  • Experimental: Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
July 2011
June 2011   (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
Both
18 Years to 70 Years
No
Contact: Jesse Wilkinson, BS 617-643-2149 jlwilkinson@partners.org
Contact: Luis Serpa, BA 617-643-4566 lserpa@partners.org
United States
 
NCT00564070
Steven Safren, PhD, Partners Healthcare
R01 MH078571, DAHBR 96-BHA
National Institute of Mental Health (NIMH)
 
Study Director: Christina Psaros, PhD Partners HealthCare
Principal Investigator: Steven Safren, PhD Partners HealthCare
National Institute of Mental Health (NIMH)
April 2009

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