Mood and Diabetes Empowerment & Improvement Training
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Empowerment and CBT Classes
- Registration Number
- NCT02010684
- Lead Sponsor
- University of California, Los Angeles
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empowerment and CBT Classes Empowerment and CBT Classes Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants will learn a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change "experiments" designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c at 6 Months Baseline and 6 months Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.
Change From Baseline in Depression Measures at 6 Months Baseline and 6 months The Geriatric Depression Scale (GDS) measures depression in older adults. The short form we used consists of 15 yes or no questions. The scale range is 0 to 15, where higher scores indicate greater severity of depression.
The Patient Health Questionnaire-9 (PHQ-9) measures depression in patients. The questionnaire consists of 9 questions where patients self report how frequently they have depression symptoms over the past two weeks. The scale ranges is 0 to 27 where higher scores indicate greater severity of depression.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Blood Pressure at 6 Months Baseline and 6 months Change From Baseline in Low Density Lipoprotein-C at 6 Months Baseline and 6 months Change From Baseline in EQ-5D at 6 Months Baseline and 6 months The EQ-5D measures general quality of life. The index score is based on 5 questions about mobility, self-care, pain, usual activities, and psychological status. The EuroQol Group provides a U.S. preference-weighted algorithm to calculate the index scores. A score of 1 indicates no problems while a score of -0.11 indicates severe problems.
The scale score is based on a visual analog of a thermostat, where 0 represents worst imaginable health and 100 represents best imaginable health. Patients mark a tick for where they feel their health is on that scale.Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months Baseline and 6 months The Diabetes Empowerment Scale Short Form (DES-SF) measures diabetes-related psychosocial self-efficacy. The questionnaire presents 8 statements on self-efficacy where participants rate how strongly they agree. The answers are summed to create a score where higher scores indicate more empowerment. The score range is 0 to 8.
Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months Baseline and 6 months The Yale Physical Activity Scale measures physical function and activities of daily living. Five activity indices (vigorous activity, leisurely walking, moving, standing and sitting) are calculated by multiplying the frequency of activity with the duration and a weighted factor. The 5 indices are then summed to create an index summary. Higher scores indicate more activity. The minimum and maximum scores are 0 and 142.
Trial Locations
- Locations (1)
UCLA Psychr & Biobehav Sci
🇺🇸Los Angeles, California, United States