Mood and Diabetes Empowerment & Improvement Training

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02010684

Acronym

MADE-IT

Enrollment

121

Registered

2013-12-13

Start date

2009-04-30

Completion date

2012-01-31

Last updated

2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

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

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.

Interventions

BEHAVIORALEmpowerment and CBT Classes

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 Blood Pressure at 6 Months	Baseline and 6 months	—
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.
Change From Baseline in Low Density Lipoprotein-C at 6 Months	Baseline and 6 months	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Wait-listed Control Group 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.	39
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.	82
Total	121

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	8	18
Overall Study	Withdrawal by Subject	4	5

Baseline characteristics

Characteristic	Wait-listed Control Group	Empowerment and CBT Classes	Total
Age, Continuous	61 years STANDARD_DEVIATION 7.8	60 years STANDARD_DEVIATION 8.4	60 years STANDARD_DEVIATION 7.9
Body Mass Index	29.0 kg/m^2 STANDARD_DEVIATION 5.7	32.6 kg/m^2 STANDARD_DEVIATION 6.4	31.4 kg/m^2 STANDARD_DEVIATION 6.4
Diastolic Blood Pressure	79.0 mm Hg STANDARD_DEVIATION 10.6	80.0 mm Hg STANDARD_DEVIATION 10.8	79.4 mm Hg STANDARD_DEVIATION 10.7
EQ-5D Index Score	0.655 units on a scale STANDARD_DEVIATION 0.2	0.795 units on a scale STANDARD_DEVIATION 0.21	0.699 units on a scale STANDARD_DEVIATION 0.21
EQ-5D Scale Score	60.2 units on a scale STANDARD_DEVIATION 19	63.6 units on a scale STANDARD_DEVIATION 13	61.3 units on a scale STANDARD_DEVIATION 17
Geriatric Depression Scale (GDS)	6.5 units on a scale STANDARD_DEVIATION 3.6	7.3 units on a scale STANDARD_DEVIATION 3.9	7.1 units on a scale STANDARD_DEVIATION 3.8
Hemoglobin A1c	10.1 % STANDARD_DEVIATION 1.7	9.8 % STANDARD_DEVIATION 1.7	9.9 % STANDARD_DEVIATION 1.7
Low Density Lipoprotein-C	110.3 mg/dL STANDARD_DEVIATION 32.4	109.6 mg/dL STANDARD_DEVIATION 37	109.8 mg/dL STANDARD_DEVIATION 35.5
Patient Health Questionnaire-9 (PHQ-9)	6.5 units on a scale STANDARD_DEVIATION 3.6	11.1 units on a scale STANDARD_DEVIATION 5.1	10.5 units on a scale STANDARD_DEVIATION 5.1
Race/Ethnicity, Customized Central American	7 participants	25 participants	32 participants
Race/Ethnicity, Customized Mexican	32 participants	57 participants	89 participants
Self-Efficacy (Diabetes Empowerment Scale)	3.88 units on a scale STANDARD_DEVIATION 2.6	3.72 units on a scale STANDARD_DEVIATION 2.5	3.77 units on a scale STANDARD_DEVIATION 2.5
Sex: Female, Male Female	29 Participants	57 Participants	86 Participants
Sex: Female, Male Male	10 Participants	25 Participants	35 Participants
Systolic Blood Pressure	137.7 mm Hg STANDARD_DEVIATION 21.4	138.9 mm Hg STANDARD_DEVIATION 19.4	138.5 mm Hg STANDARD_DEVIATION 20
Yale Physical Activity Scale - Index Summary Score	45.8 units on a scale STANDARD_DEVIATION 28	48.3 units on a scale STANDARD_DEVIATION 28	47.5 units on a scale STANDARD_DEVIATION 28

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 39	0 / 82
serious Total, serious adverse events	0 / 39	0 / 82

Outcome results

Primary

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.