A Pychoeducational Intervention for Women With Diabetes (SWEEP)

This study has been completed.
Sponsor:
Information provided by:
Loyola University
ClinicalTrials.gov Identifier:
NCT01185561
First received: August 18, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • dysphoric symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To determine the effect of a psychoeducational intervention on dysphoric symptoms.


Secondary Outcome Measures:
  • 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
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 CES-D 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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185561

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
  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 April 16, 2014