Trial Outcomes & Findings for Mood and Diabetes Empowerment & Improvement Training (NCT NCT02010684)
NCT ID: NCT02010684
Last Updated: 2015-06-01
Results Overview
Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2015-06-01
Participant Flow
Participant milestones
| Measure |
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.
|
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. Then participants will learn a diabetes education format 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. Group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.
Empowerment and CBT Classes: Participants 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 Modu
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|---|---|---|
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Overall Study
STARTED
|
39
|
82
|
|
Overall Study
COMPLETED
|
27
|
59
|
|
Overall Study
NOT COMPLETED
|
12
|
23
|
Reasons for withdrawal
| Measure |
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.
|
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. Then participants will learn a diabetes education format 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. Group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.
Empowerment and CBT Classes: Participants 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 Modu
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|---|---|---|
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Overall Study
Lost to Follow-up
|
8
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18
|
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Overall Study
Withdrawal by Subject
|
4
|
5
|
Baseline Characteristics
Mood and Diabetes Empowerment & Improvement Training
Baseline characteristics by cohort
| Measure |
Wait-listed Control Group
n=39 Participants
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
n=82 Participants
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.
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Total
n=121 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
61 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 8.4 • n=7 Participants
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60 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
32 participants
n=5 Participants
|
57 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Central American
|
7 participants
n=5 Participants
|
25 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Hemoglobin A1c
|
10.1 %
STANDARD_DEVIATION 1.7 • n=5 Participants
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9.8 %
STANDARD_DEVIATION 1.7 • n=7 Participants
|
9.9 %
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Diastolic Blood Pressure
|
79.0 mm Hg
STANDARD_DEVIATION 10.6 • n=5 Participants
|
80.0 mm Hg
STANDARD_DEVIATION 10.8 • n=7 Participants
|
79.4 mm Hg
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Systolic Blood Pressure
|
137.7 mm Hg
STANDARD_DEVIATION 21.4 • n=5 Participants
|
138.9 mm Hg
STANDARD_DEVIATION 19.4 • n=7 Participants
|
138.5 mm Hg
STANDARD_DEVIATION 20 • n=5 Participants
|
|
Low Density Lipoprotein-C
|
110.3 mg/dL
STANDARD_DEVIATION 32.4 • n=5 Participants
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109.6 mg/dL
STANDARD_DEVIATION 37.0 • n=7 Participants
|
109.8 mg/dL
STANDARD_DEVIATION 35.5 • n=5 Participants
|
|
Geriatric Depression Scale (GDS)
|
6.5 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 3.9 • n=7 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Patient Health Questionnaire-9 (PHQ-9)
|
6.5 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 5.1 • n=7 Participants
|
10.5 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
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EQ-5D
Scale Score
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60.2 units on a scale
STANDARD_DEVIATION 19 • n=5 Participants
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63.6 units on a scale
STANDARD_DEVIATION 13 • n=7 Participants
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61.3 units on a scale
STANDARD_DEVIATION 17 • n=5 Participants
|
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EQ-5D
Index Score
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0.655 units on a scale
STANDARD_DEVIATION 0.20 • n=5 Participants
|
0.795 units on a scale
STANDARD_DEVIATION 0.21 • n=7 Participants
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0.699 units on a scale
STANDARD_DEVIATION 0.21 • n=5 Participants
|
|
Yale Physical Activity Scale - Index Summary Score
|
45.8 units on a scale
STANDARD_DEVIATION 28 • n=5 Participants
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48.3 units on a scale
STANDARD_DEVIATION 28 • n=7 Participants
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47.5 units on a scale
STANDARD_DEVIATION 28 • n=5 Participants
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Self-Efficacy (Diabetes Empowerment Scale)
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3.88 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
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3.72 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
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3.77 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
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Body Mass Index
|
29.0 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
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32.6 kg/m^2
STANDARD_DEVIATION 6.4 • n=7 Participants
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31.4 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and 6 monthsHemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.
Outcome measures
| Measure |
Wait-listed Control Group
n=27 Participants
Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted 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 also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will 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
n=59 Participants
Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned 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.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c at 6 Months
|
-0.7 percentage of glycated hemoglobin
Standard Deviation 1.5
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-1.6 percentage of glycated hemoglobin
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsThe 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.
Outcome measures
| Measure |
Wait-listed Control Group
n=28 Participants
Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted 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 also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will 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
n=61 Participants
Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned 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.
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|---|---|---|
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Change From Baseline in Depression Measures at 6 Months
Geriatric Depression Scale
|
-0.4 units on a scale
Standard Deviation 6.6
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-4.7 units on a scale
Standard Deviation 4.3
|
|
Change From Baseline in Depression Measures at 6 Months
Patient Health Questionnaire-9
|
0.4 units on a scale
Standard Deviation 4.8
|
-6.9 units on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsOutcome measures
| Measure |
Wait-listed Control Group
n=27 Participants
Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted 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 also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will 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
n=55 Participants
Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned 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.
|
|---|---|---|
|
Change From Baseline in Blood Pressure at 6 Months
Systolic Blood Pressure
|
1.9 mm Hg
Standard Deviation 13
|
-0.9 mm Hg
Standard Deviation 24
|
|
Change From Baseline in Blood Pressure at 6 Months
Diastolic Blood Pressure
|
1.30 mm Hg
Standard Deviation 7.4
|
-1.25 mm Hg
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsOutcome measures
| Measure |
Wait-listed Control Group
n=27 Participants
Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted 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 also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will 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
n=55 Participants
Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned 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.
|
|---|---|---|
|
Change From Baseline in Low Density Lipoprotein-C at 6 Months
|
0.04 mg/dL
Standard Deviation 57
|
1.9 mg/dL
Standard Deviation 35
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SECONDARY outcome
Timeframe: Baseline and 6 monthsThe 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.
Outcome measures
| Measure |
Wait-listed Control Group
n=28 Participants
Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted 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 also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will 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
n=61 Participants
Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned 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.
|
|---|---|---|
|
Change From Baseline in EQ-5D at 6 Months
Scale
|
1.75 units on a scale
Standard Deviation 19
|
14.7 units on a scale
Standard Deviation 21
|
|
Change From Baseline in EQ-5D at 6 Months
Index Score
|
-0.02 units on a scale
Standard Deviation 0.2
|
0.11 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThe 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.
Outcome measures
| Measure |
Wait-listed Control Group
n=28 Participants
Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted 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 also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will 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
n=61 Participants
Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned 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.
|
|---|---|---|
|
Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months
|
-10.5 units on a scale
Standard Deviation 28
|
21.5 units on a scale
Standard Deviation 34
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThe 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.
Outcome measures
| Measure |
Wait-listed Control Group
n=28 Participants
Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted 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 also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will 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
n=61 Participants
Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned 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.
|
|---|---|---|
|
Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months
|
-1.31 units on a scale
Standard Deviation 2.9
|
4.31 units on a scale
Standard Deviation 2.8
|
Adverse Events
Wait-listed Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Empowerment and CBT Classes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeanne Miranda
University of California Los Angeles
Phone: 310-794-3710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place