N/A
N=121
Mood and Diabetes Empowerment & Improvement Training
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02010684 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Change From Baseline in Hemoglobin A1c at 6 Months — -0.7; -1.6 percentage of glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Empowerment and CBT Classes (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c at 6 Months |
-0.7; -1.6 | — |
| PRIMARY Change From Baseline in Depression Measures at 6 Months |
-0.4; -4.7; 0.4; -6.9 | — |
| SECONDARY Change From Baseline in Blood Pressure at 6 Months |
1.9; -0.9; 1.30; -1.25 | — |
| SECONDARY Change From Baseline in Low Density Lipoprotein-C at 6 Months |
0.04; 1.9 | — |
| SECONDARY Change From Baseline in EQ-5D at 6 Months |
1.75; 14.7; -0.02; 0.11 | — |
| SECONDARY Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months |
-10.5; 21.5 | — |
| SECONDARY Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months |
-1.31; 4.31 | — |
Summary
In this project, investigators examine the impact of a mood treatment enhanced diabetes self-care intervention for depressed, low-income Latino diabetics. The investigators hypothesize that the mood treatment enhancement will lead to significant improvement in both diabetes and depression outcomes as compared with the self-care intervention alone.
Eligibility Criteria
Inclusion Criteria
- Latino men and women age 50 and older
- Must speak English or Spanish
- Hb A1c greater than or equal to 8%
- Currently not taking medication for depression
- A score of 5 or greater on the Geriatric Depression Scale (GDS)
Exclusion Criteria
- Persons who are legally blind, dialysis dependent, diagnosed with dementia, and/or with hemiparesis from a cerebral vascular accident
- Do not have sufficient hearing or cognitive function
Data sourced from ClinicalTrials.gov (NCT02010684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.