Trial Outcomes & Findings for Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes (NCT NCT03562767)
NCT ID: NCT03562767
Last Updated: 2023-08-02
Results Overview
Feasibility of the intervention will be measured as the percentage of participants who complete the study. The intervention will be considered feasible if no more than 20% of participants are lost to follow up.
TERMINATED
NA
20 participants
3 months post randomization
2023-08-02
Participant Flow
A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.
Participant milestones
| Measure |
Group-based Cognitive Behavioral Intervention
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
0
|
|
Overall Study
COMPLETED
|
7
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
Group-based Cognitive Behavioral Intervention
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
|
Overall Study
Logistic Reason
|
1
|
3
|
0
|
Baseline Characteristics
Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes
Baseline characteristics by cohort
| Measure |
Group-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<55 Years Old
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Customized
≥55 Years Old
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
—
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
—
|
14 participants
n=4 Participants
|
|
BMI
Normal (BMI 18.5-24.9 kg/m^2)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
BMI
Overweight (BMI 25.0-29.9 kg/m^2)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
BMI
Obese (BMI >= 30.0 kg/m^2)
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 months post randomizationPopulation: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.
Feasibility of the intervention will be measured as the percentage of participants who complete the study. The intervention will be considered feasible if no more than 20% of participants are lost to follow up.
Outcome measures
| Measure |
Group-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
|---|---|---|---|
|
Percentage of Participants That Complete the Study Compared to Enrolled
|
7 Participants
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 months post randomizationPopulation: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated
Acceptability of the intervention will be operationalized as study session attendance and will be considered adequate if at least 70% of the sessions are attended.
Outcome measures
| Measure |
Group-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
|---|---|---|---|
|
Percentage of Participants That Are Enrolled and Attend the Study the Study Sessions Compared to Enrolled
|
7 Participants
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 months post randomizationPopulation: The A1C results may be affected by variations in point of care vs regular blood testing and the timing of follow up for participants. Data is included for participants who completed more than 65% of the intervention sessions.
Hemoglobin A1c (HbA1C) in % will be measured via blood draw and processing. Normal values HbA1C are less than 5.7%, values between 5.7% and 6.4% indicate pre-diabetes, and persons with levels of 6.5% or higher are considered to have diabetes.
Outcome measures
| Measure |
Group-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
|---|---|---|---|
|
Change in Hemoglobin A1c (HbA1C) Level
Baseline
|
10.35 percentage of HbA1C
Standard Deviation 1.01
|
9.67 percentage of HbA1C
Standard Deviation 1.39
|
—
|
|
Change in Hemoglobin A1c (HbA1C) Level
Month 3
|
9.21 percentage of HbA1C
Standard Deviation 0.91
|
8.74 percentage of HbA1C
Standard Deviation 2.06
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 months post randomizationPopulation: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated
Depressive symptoms are assessed by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item scale where respondents indicate how much they are bothered by certain problems on a 4-point scale where 0 = not at all and 3 = nearly every day. Total scores range from 0 to 27 with degree of depression considered minimal for scores between 0-4, mild for scores of 5-9, moderate for scores of 10-14, moderate to severe for scores 15-19, and severe for scores of 20-27.
Outcome measures
| Measure |
Group-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
|---|---|---|---|
|
Change in Patient Health Questionnaire (PHQ-9) Score
Baseline
|
7.29 Score on a scale
Standard Deviation 5.47
|
6.00 Score on a scale
Standard Deviation 4.90
|
—
|
|
Change in Patient Health Questionnaire (PHQ-9) Score
3 months post randomization
|
7.71 Score on a scale
Standard Deviation 6.92
|
5.00 Score on a scale
Standard Deviation 3.87
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 months post randomizationPopulation: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.
The Diabetes Distress Scale (DDS17) is a 17-item questionnaire assessing the severity of problems of living with diabetes. Participants indicate the degree to which each item impacts their life on a 6-point scale where 1 = not a problem and 6 = a very serious problem. The scores are summed and divided by 17 to generate an average score that can range from 1 to 6. Scores of 3 or more are considered high distress.
Outcome measures
| Measure |
Group-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
|---|---|---|---|
|
Change in Diabetes Distress Scale (DDS17) Score
Baseline
|
2.35 score on a scale
Standard Deviation 0.82
|
2.57 score on a scale
Standard Deviation 0.90
|
—
|
|
Change in Diabetes Distress Scale (DDS17) Score
3 months post randomization
|
1.74 score on a scale
Standard Deviation 0.64
|
2.15 score on a scale
Standard Deviation 0.99
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 months post randomizationPopulation: There was an error in data collection forms provided to participants, which made these questionnaires unusable for data analysis.
Quality of life will be assessed with the 12-Item Short Form Health Survey (SF-12). The Short Form-12 Health Survey Questionnaire (SF-12) is a measure of general physical and mental health. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 months post randomizationPopulation: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.
Anxiety will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) Scale. Participants use a 4-point scale in response to statements about anxiety (such as "trouble relaxing") to indicate how bothered they have felt by item over the last two weeks. Degree of anxiety is rated as 0 = "not at all" to 3 = "nearly every day". Total scores range from 0 to 21. Scores of 5-9 indicate mild anxiety, 10-15 indicates moderate anxiety and scores 15 and greater indicate severe anxiety.
Outcome measures
| Measure |
Group-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
|---|---|---|---|
|
Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score
Baseline
|
7.14 score on a scale
Standard Deviation 4.63
|
5.57 score on a scale
Standard Deviation 7.28
|
—
|
|
Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score
3 months post randomization
|
6.00 score on a scale
Standard Deviation 5.80
|
2.43 score on a scale
Standard Deviation 4.47
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 months post randomizationChange in Self Efficacy is assessed by Self Efficacy for Diabetes Scale that is administered at Baseline and at 3rd month post randomization. The questionnaire is a 8 item scale. Each question ranks from 1(not confident at all) to 10 (totally confident). The scale score will be compared from Baseline to 3 months post randomization. For diabetes, higher diabetes self-efficacy has been shown to relate to better self-care and glycaemic control. Increase in the score of Self-efficacy is found to directly reinforce adherence to self-care.
Outcome measures
| Measure |
Group-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the group-based CT-CB intervention
Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
|
Web-based Cognitive Behavioral Intervention
n=7 Participants
Subjects receiving the web based CT-CB intervention
Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
|
Usual Care
Subjects receiving usual care from their primary care providers
Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
|
|---|---|---|---|
|
Change in Self Efficacy for Diabetes
Baseline
|
7.34 score on a scale
Standard Deviation 1.43
|
6.94 score on a scale
Standard Deviation 2.10
|
—
|
|
Change in Self Efficacy for Diabetes
3 months post randomization
|
7.43 score on a scale
Standard Deviation 2.20
|
6.77 score on a scale
Standard Deviation 1.84
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 months post randomizationPopulation: This survey was not administered to participants.
Change in Diabetes Health Belief Scale is assessed by 25-item scale that is administered at baseline and at 3 months post randomization.Each question ranks from (1 = Strongly Disagree) to (5 = Strongly Agree).The scale score will be compared from Baseline to 3 months post randomization
Outcome measures
Outcome data not reported
Adverse Events
Group-based Cognitive Behavioral Intervention
Web-based Cognitive Behavioral Intervention
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place