CBT for Adherence and Depression in Diabetes
Condition: Diabetes Mellitus; Depression
MeSH terms: Diabetes Mellitus; Depression; Depressive Disorder
Study type: Interventional

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 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.
    

Intervention name(s): Enhanced treatment as usual plus adherence training; Enhanced treatment as usual plus CBT-AD
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Diabetes; Adherence