Mood and Diabetes Empowerment & Improvement Training

NCT02010684 | Completed Results

• 1 other identifier: MADE-IT Study 1P20MD00148-03
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Depression; Self care; Empowerment; Behavioral intervention; Cognitive behavioral therapy; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

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

  Baseline and 6 months

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

  Baseline and 6 months

Study Arms (2)

Wait-listed Control Group

NO INTERVENTION

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.

Empowerment and CBT Classes

EXPERIMENTAL

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

Interventions

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.

Also known as: CBT Classes, Diabetes Classes

Empowerment and CBT Classes

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Psychr & Biobehav Sci

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Depression; Empowerment

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Social Behavior

Results Point of Contact

• Title: Dr. Jeanne Miranda
• Organization: University of California Los Angeles

mirandaj@ucla.edu

310-794-3710

Study Officials

• Jeanne Miranda, PhD

  UCLA Psychr & Biobehav Sci

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeanne Miranda Ph.D.

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: December 13, 2013
• Study Start: April 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 1, 2015
• Results First Posted: June 1, 2015

Record last verified: 2015-05

Locations

US (1)