CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
Psychoeducational interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01185561
NCT01185561N/ACompleted

A Pychoeducational Intervention for Women With Diabetes

Loyola University·interventional·Posted Aug 20, 2010·Updated Dec 14, 2016

In Brief

A clinical study evaluating Psychoeducational intervention for Depression and 2 related conditions. Completed, enrolled 74 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 20, 2010
Enrollment StartMar 1, 2007
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.9 years ago

Interventions

Psychoeducational interventionbehavioral

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.