Mood and Diabetes Empowerment & Improvement Training

Study Overview
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Brief Summary
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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
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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.

Official Title
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University of California, Los Angeles (UCLA)/Drew Project EXPORT: Mood and Diabetes Empowerment & Improvement Training (MADE IT)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Empowerment and CBT Classes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait-listed Control Group<br>Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results. | |
| Experimental: Empowerment and CBT Classes<br>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. | Behavioral: Empowerment and CBT Classes<br>* Participants randomized to the intervention arm will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers Understanding Depression and Diabetes, Module 2 How Thoughts Affect Your Mood and Diabetes Care, Module 3 How Activities Affect Your Mood and Diabetes Care. The Diabetes Empowerment Module covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources.<br>* Other names: Diabetes Classes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c at 6 Months | Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test. | Baseline and 6 months | 
| Change From Baseline in Depression Measures at 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. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Baseline and 6 months | 
| Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 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. | Baseline and 6 months | 
| Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 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. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Depression, Self care, Empowerment, Behavioral intervention, Cognitive behavioral therapy, Diabetes Mellitus, Type 2