Depression Clinical Trial
Official title:
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.
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