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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.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Cognitive Behavioral Therapy in Improving Adherence and Depressive Symptoms in People With Diabetes
Official Title  CBT for Adherence and Depression in Diabetes
Brief Summary

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

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 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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
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 ]
Secondary Outcome Measure  Biomedical outcomes (hemoglobin A1C and self-monitored blood glucose values) [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: Yes ]
Condition  Diabetes Mellitus
Depression
Intervention  Behavioral: Enhanced treatment as usual plus adherence training
Behavioral: Enhanced treatment as usual plus CBT-AD
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  100
Start Date  July 2007
Completion Date July 2011
Eligibility Criteria 

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

Exclusion Criteria:

  • Active untreated major mental illness (e.g., untreated psychosis), bipolar disorder, eating disorder, mental retardation, or dementia
  • Experiencing suicidal thoughts
  • Taking an antidepressant, oral hypoglycemic, or insulin prescription and is stable for 2 months prior to study entry
  • History of or currently receiving CBT for depression
  • Uses an insulin pump
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Erin Marie Collins, BA     617-643-2149     emcollins@partners.org    
Contact: Luis Serpa, BA     617-643-4566     lserpa@partners.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00564070
Organization ID R01 MH78571
Secondary IDs †† DAHBR 96-BHA
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Steven Safren, PhD     Partners HealthCare    
Study Director:     Jeffrey Gonzalez, PhD     Partners HealthCare    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  November 23, 2007
Last Updated Date February 12, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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