Clinical trial NCT02010684: Mood and Diabetes Empowerment & Improvement Training
Official title: University of California, Los Angeles (UCLA)/Drew Project EXPORT: Mood and Diabetes Empowerment & Improvement Training (MADE IT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Depression
Self care
Empowerment
Behavioral intervention
Cognitive behavioral therapy
Diabetes Mellitus, Type 2
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 121
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The Phase I pilot recruited older Latinos from Dr. Mangione's previous study (who agreed to participate in future research) and 10 participants from a community settings. Those with low mood and poor glycemic control were offered a 12-week intervention combining cognitive behavioral therapy mood management techniques and diabetes self-care into one seamless intervention. Drs. Mangione and Miranda supervised and reviewed (through audiotapes) well-trained health educators conducting the intervention sessions. The study manuals were modified following this Phase I pilot intervention.

The final intervention manual was tested in a randomized trial in Phase II, compared the Mood and Diabetes Empowerment and Improvement Training intervention with enhanced care as usual (providing participants with a letter regarding their mood and hemoglobin (Hb)A1c with recommendations for improving care for their provider). The target population was low-income Latinos with depression and poor glycemic control. Both mood and diabetes outcomes are evaluated.

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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Depression Measures at 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change From Baseline in Blood Pressure at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Low Density Lipoprotein-C at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in EQ-5D at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Psychr & Biobehav Sci
state: California
Study officials:
affiliation: UCLA Psychr & Biobehav Sci
name: Jeanne Miranda, PhD
role: PRINCIPAL_INVESTIGATOR
References: