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Completed

NCT Number: NCT02010684

Mood and Diabetes Empowerment & Improvement Training

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Behavioral Symptoms Depression Diabetes Mellitus Empowerment Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Social Behavior

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Psychr & Biobehav Sci

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empowerment and CBT Classes

Behavioral

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.

Other names: CBT Classes, Diabetes Classes

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c at 6 Months

    Time frame: 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.

  2. Change From Baseline in Depression Measures at 6 Months

    Time frame: 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 outcomes

  1. Change From Baseline in Blood Pressure at 6 Months

    Time frame: Baseline and 6 months

  2. Change From Baseline in Low Density Lipoprotein-C at 6 Months

    Time frame: Baseline and 6 months

  3. Change From Baseline in EQ-5D at 6 Months

    Time frame: 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.

  4. Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months

    Time frame: 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.

  5. Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Acronym: MADE-IT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 13, 2013
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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