N/A
Completed N=74
A Pychoeducational Intervention for Women With Diabetes
Source: ClinicalTrials.gov NCT01185561 ↗Enrolled (actual)
74
Serious AEs
1.4%
Results posted
Dec 2016
Primary outcomePrimary: Center for Epidemiologic Studies Depression (CES-D) Score — 12.6; 21.5 units on a scale — p=.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Center for Epidemiologic Studies Depression (CES-D) Score |
12.6; 21.5 | .001 sig |
| SECONDARY State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score |
35.7; 43.6 | .02 sig |
| SECONDARY State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score |
36.9; 45.3 | .005 sig |
| SECONDARY State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score |
28.9; 29.6 | .85 |
Eligibility Criteria
Inclusion Criteria
- aged 18 to 75 years;
- have type 2 diabetes greater than six months and being medically managed
- score greater than or equal to 16 on the Center for Epidemiological Studies Depression (CES-D) scale which is indicative of depressive symptoms.
- 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)
Data sourced from ClinicalTrials.gov (NCT01185561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.