A Pychoeducational Intervention for Women With Diabetes
Condition: Depression; Anxiety; Anger
MeSH terms: Depression
Study type: Interventional

Summary: 
      This proposal describes a small randomized study to determine whether usual medical care
      (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for
      diabetes alone. This program differs from other diabetes programs by focusing on the
      management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes
      self-care behaviors will be discussed and measured, but they are not the primary focus of the
      intervention. The psychoeducational program will address: 1) education about how dysphoric
      symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of
      dysphoric symptoms using Cognitive Behavioral Therapy (CBT). Subjects will be randomized to
      receive the group psychoeducational intervention or no additional treatment. All subjects
      will receive UMC for diabetes.
    

Detailed description: 
      Diabetes is the fifth deadliest disease in the United States with no known cure, and
      cardiovascular disease (CVD) is the leading cause of death in persons with diabetes. Diabetes
      is the only disease that causes women to have as much heart disease as men. The relative risk
      of cardiac mortality has been reported to be 2.6 for women with diabetes as compared to 1.9
      for men with diabetes after controlling for other cardiac risk factors. While cardiac
      mortality for men with diabetes has declined (13.1%), there has been a 23% increase in
      age-adjusted cardiac mortality for women with diabetes. This poor outcome, occurring in a
      time of significant advances in the management of heart disease, suggests the need to
      consider directing treatment at other risk factors. Depression may be one such risk factor.

      Depression is an independent risk factor for CVD, and is associated with poorer
      self-management and decreased health-related quality of life. Approximately 25% of persons
      with diabetes have depression, and the rate of depression in women with diabetes is double
      that of men with diabetes. Women with diabetes exhibit worse diabetes self-care, glycemic
      control, and poorer quality of life than men with diabetes, which are exacerbated by
      depression. Other affective symptoms including anxiety and anger commonly accompany
      depressive symptoms appear to impose similar risks for poor medical outcomes, and occur more
      often in women with diabetes than men with diabetes.

      Research has shown that treatment of depression with medication and/or cognitive behavioral
      therapy (CBT) effectively relieves depression and improves glycemic control in persons with
      diabetes. More recent evidence suggests that these benefits are more durable in patients
      treated with CBT vs. antidepressants alone. There has been no research on "symptom clusters"
      (i.e., depression, anxiety, and anger) in persons with diabetes, and their effect on glycemic
      control and self-management. In addition, a CBT program to treat a cluster of dysphoric
      symptoms has not been tested in persons with diabetes. Since women with diabetes have greater
      depression and anxiety, worse glycemic control, and increased cardiac mortality than men with
      diabetes, we are proposing to test the feasibility and effectiveness of a psychoeducational
      intervention to promote emotional health in women with type 2 diabetes.

      This proposal describes a small randomized controlled trial to determine whether usual
      medical care (UMC) for diabetes combined with a psychoeducational program is more effective
      than UMC for diabetes alone. This program differs from other diabetes programs by focusing on
      the management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes
      self-care behaviors will be discussed and measured, but they are not the primary focus of the
      intervention. The psychoeducational program will address: 1) education about how dysphoric
      symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of
      dysphoric symptoms using CBT. A repeated measures, experimental design will be used. Subjects
      will be randomized to receive the group psychoeducational intervention or no additional
      treatment. All subjects will receive UMC for diabetes. The aims and hypotheses for the study
      are:

      Primary Aim: To determine the effect of a psychoeducational intervention on dysphoric
      symptoms. The primary hypothesis is that women receiving a psychoeducational intervention
      plus UMC will report fewer dysphoric symptoms (depression, anxiety, and anger) at three and
      six months follow-up.

      Secondary Aim: To determine the effect of a psychoeducational intervention on glycemic
      control, diabetes self-management, and health-related quality of life. The secondary
      hypothesis is that women receiving a psychoeducational intervention plus UMC will have
      decreased hemoglobin A1c, report better diabetes self-management (increased self-care
      behaviors and self-efficacy), and report increased health-related quality of life (increased
      functional status, life satisfaction, and decreased diabetes-related distress) at three and
      six months follow-up.
    

Intervention name(s): Psychoeducational intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; SWEEP; Dysphoria