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NCT01185561 · ClinicalTrials.gov registry record · NA
A Pychoeducational Intervention for Women With Diabetes
A NA study, sponsored by Loyola University.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
NCT01185561: Completed NA study, sponsored by Loyola University.
NCT01185561 is a NA study that has completed, run by Loyola University. The registered enrollment target is 74 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01185561, a NA study, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
Study 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.
Primary Outcome
The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.
Interventions
- BEHAVIORAL Psychoeducational intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-11 |
| Phase | NA |
What the finished NCT01185561 record still lists
NCT01185561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Psychoeducational intervention is the first listed.
NCT01185561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01185561 about?
NCT01185561 is a clinical study titled "A Pychoeducational Intervention for Women With Diabetes". 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 (...
What is the current status of trial NCT01185561?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2007-03. Estimated completion is 2009-11.
What interventions are being tested in trial NCT01185561?
The interventions under investigation include: Psychoeducational intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01185561?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01185561's enrollment target sits among peer trials
74 1082nd of 2000 higher than 912 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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