A Pychoeducational Intervention for Women With Diabetes (SWEEP)
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Purpose
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. Subjects will be randomized to receive the group psychoeducational intervention or no additional treatment. All subjects will receive UMC for diabetes
| Condition | Intervention |
|---|---|
|
Dysphoric Symptoms |
Behavioral: psychoeducational intervention Behavioral: usual medical care (control group). |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pychoeducational Intervention for Women With Diabetes |
- dysphoric symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]To determine the effect of a psychoeducational intervention on dysphoric symptoms.
- glycemic control [ Time Frame: 6 months ] [ Designated as safety issue: No ]To determine the effect of a psychoeducational intervention on glycemic control, diabetes self-management, and health-related quality of life.
| Enrollment: | 64 |
| Study Start Date: | January 2007 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Group I ; usual medical care
Group I will receive usual medical care (control group).
|
Behavioral: usual medical care (control group).
Group I will receive usual medical care (control group).
|
|
Active Comparator: Group II ; psychoeducational intervention
medical care plus psychoeducational intervention
|
Behavioral: psychoeducational intervention
1) education about how dysphoric symptoms (depressive symptoms, anxiety, and anger) affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of dysphoric symptoms using cognitive-behavioral skills. Supportive phone calls (weeks 10, 18) and booster sessions (weeks 14 and 22) and will be used to sustain the treatment effect.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 CES-D 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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sue Penckofer, Loyola University Chicago |
| ClinicalTrials.gov Identifier: | NCT01185561 History of Changes |
| Other Study ID Numbers: | 108324 |
| Study First Received: | August 18, 2010 |
| Last Updated: | August 18, 2010 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 22, 2013