Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes

• ClinicalTrials.gov Identifier: NCT03562767
• Recruitment Status: Terminated
• First Posted: June 19, 2018
• Results First Posted: January 3, 2022
• Last Update Posted: January 3, 2022
• Sponsor: Emory University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Ambar Kulshreshtha, Emory University

Study Description

Brief Summary:

The main purpose of the study is to assess the feasibility and acceptability of a Culturally-Tailored Cognitive Behavior intervention (CT-CB) for African American patients with uncontrolled Type 2 diabetes. After the baseline visit subjects will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (CT-CB) program or to general education (usual care). The intervention duration is 12 weeks.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: Group-based Cognitive Behavioral Intervention; Behavioral: Web-based Cognitive Behavioral Intervention; Behavioral: Usual Care	Not Applicable

Detailed Description:

African Americans are approximately twice as likely to be diagnosed with diabetes and to experience gaps in diabetes care compared to Whites. Lower health literacy and socio-economic, language, and communication barriers are all associated with disparities in diabetes care. The role of Behavioral theory is foundational in understanding behavior change among patients in the self-management of diabetes. Further culturally tailoring increases acceptance and effectiveness of diabetes self-management.

The aim of this pilot study is to test the feasibility and acceptability of a culturally tailored, cognitive behavioral intervention (CT-CB) program using a group-based vs. a web-based format, and determine if it can improve diabetes self-management among African Americans compared with usual individual based care at the clinic. Forty-five African American patients with uncontrolled type 2 diabetes (HbA1C > 8 %), aged > 18 years, will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (CT-CB) program or to general education (usual care). After 12 weeks, patients will be followed for an additional three months to evaluate for diminution of treatment effects. Both the group -based and the web-based CBT intervention group will be followed for an additional three months to study for possible diminution of treatment effects over time.

Diabetic measures like Hemoglobin (HbA1C) at baseline vs. 3 months; the Patient Health Questionnaire to assess depressive symptoms; Diabetes Distress Scale, anxiety, self-efficacy, quality of life (SF-12), Diabetes Health Belief Scale, process measures such as Patient Activation Measure (PAM-13), medication adherence questionnaire, session-participation, glucose self-monitoring, diet and physical activity are measured at each visit pre and post intervention. Trained study staff will also conduct neuropsychological tests including language and memory tests, attention and executive function tests, clinical diagnosis, activities of daily living (ADL).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Three groups of subjects with uncontrolled diabetes Type 2 will be followed longitudinally for 3 months
• Masking: Single (Outcomes Assessor)
• Masking Description: Research staff conducting the psychological, physical, outcome assessments, and study analyses will be blinded to participant's group allocation. To minimize bias, participants in the intervention group will be asked to refrain from disclosing their group assignment to study staff who collect data and questionnaires. Due to the overt nature of the CT-CB approach, the investigators and participants in the intervention group will not be blinded.
• Primary Purpose: Supportive Care
• Official Title: A Randomized Single Blinded Interventional Study to Assess the Feasibility and Acceptability of a Culturally-Tailored Cognitive Behavior Intervention (CT-CB) for African American Patients With Uncontrolled Type 2 Diabetes and to Compare the Effects of Intervention to Standard of Care on Diabetes Control Measures.
• Actual Study Start Date: December 5, 2018
• Actual Primary Completion Date: May 30, 2019
• Actual Study Completion Date: May 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group-based Cognitive Behavioral Intervention; Subjects receiving the group-based CT-CB intervention	Behavioral: 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.
Experimental: Web-based Cognitive Behavioral Intervention; Subjects receiving the web based CT-CB intervention	Behavioral: 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.
Placebo Comparator: Usual Care; Subjects receiving usual care from their primary care providers	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants That Complete the Study Compared to Enrolled [ Time Frame: 3 months post randomization ]
   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.
2. Percentage of Participants That Are Enrolled and Attend the Study the Study Sessions Compared to Enrolled [ Time Frame: 3 months post randomization ]
   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.

Secondary Outcome Measures :

1. Change in Hemoglobin A1c (HbA1C) Level [ Time Frame: Baseline and 3 months post randomization ]
   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.
2. Change in Patient Health Questionnaire (PHQ-9) Score [ Time Frame: Baseline and 3 months post randomization ]
   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.
3. Change in Diabetes Distress Scale (DDS17) Score [ Time Frame: Baseline and 3 months post randomization ]
   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.
4. Change in 12-Item Short Form Health Survey (SF-12) Score [ Time Frame: Baseline and 3 months post randomization ]
   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.
5. Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score [ Time Frame: Baseline and 3 months post randomization ]
   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.
6. Change in Self Efficacy for Diabetes [ Time Frame: Baseline and 3 months post randomization ]

   Change 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.

7. Change in Diabetes Health Belief Scale [ Time Frame: Baseline and 3 months post randomization ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age: 18 years or older
• Fluency in English
• African American
• HbA1C>8%

Exclusion Criteria:

• Subjects with no web access,
• Subjects using an insulin pump,
• Subjects that are pregnant
• Subjects that have active substance abuse including alcohol,
• Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions

Contacts and Locations

Locations

United States, Georgia

Emory Dunwoody Clinic

Atlanta, Georgia, United States, 30338

Sponsors and Collaborators

Emory University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Ambar Kulshreshtha, MD, PhD FAHA; Emory University

  Study Documents (Full-Text)

Documents provided by Ambar Kulshreshtha, Emory University:

Study Protocol and Statistical Analysis Plan  [PDF] October 1, 2017

More Information

• Responsible Party: Ambar Kulshreshtha, Assistant Professor, Department of Family and Preventive Medicine, Emory University
• ClinicalTrials.gov Identifier: NCT03562767
• Other Study ID Numbers: IRB00101847; P30DK111024 ( U.S. NIH Grant/Contract )
• First Posted: June 19, 2018
• Results First Posted: January 3, 2022
• Last Update Posted: January 3, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan to share the participants data

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ambar Kulshreshtha, Emory University:

Culturally-Tailored Cognitive Behavior intervention (CT-CB); Family Practice; Diabetes

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases