Clinical trial NCT01185561: A Pychoeducational Intervention for Women With Diabetes
Official title: A Pychoeducational Intervention for Women With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Anger
Keywords: Diabetes
SWEEP
Dysphoria
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. aged 18 to 75 years;
2. have type 2 diabetes greater than six months and being medically managed
3. score greater than or equal to 16 on the Center for Epidemiological Studies Depression (CES-D) scale which is indicative of depressive symptoms.
4. score greater than or equal to 12 on the CES-D plus a history of depression or currently being treated for depression.

Exclusion Criteria:

Women with current alcohol or substance abuse disorders, or a history of bipolar depression or any other psychotic disorder will be excluded.

Women will also be excluded if they have a diabetes knowledge test score of less than 70% and severe complications of diabetes (blindness, renal failure, or major amputation which includes most toes, foot, knee, or leg)

Primary outcomes:
measure: Center for Epidemiologic Studies Depression (CES-D) Score
timeFrame: 6 Months
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score
timeFrame: 6 Months
measure: State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score
timeFrame: 6 Months
measure: State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score
timeFrame: 6 Months
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Sue Penckofer, PhD
role: PRINCIPAL_INVESTIGATOR
References: