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A Pychoeducational Intervention for Women With Diabetes

NCT01185561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2016-12-14

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Psychoeducational intervention

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.

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Sue Penckofer, PhD · Loyola University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01185561 on ClinicalTrials.gov