Clinical trial NCT03562767: Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Culturally-Tailored Cognitive Behavior intervention (CT-CB)
Family Practice
Diabetes
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups of subjects with uncontrolled diabetes Type 2 will be followed longitudinally for 3 months
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility 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

Primary outcomes:
measure: Percentage of Participants That Complete the Study Compared to Enrolled
timeFrame: 3 months post randomization
measure: Percentage of Participants That Are Enrolled and Attend the Study the Study Sessions Compared to Enrolled
timeFrame: 3 months post randomization
Secondary outcomes:
measure: Change in Hemoglobin A1c (HbA1C) Level
timeFrame: Baseline and 3 months post randomization
measure: Change in Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline and 3 months post randomization
measure: Change in Diabetes Distress Scale (DDS17) Score
timeFrame: Baseline and 3 months post randomization
measure: Change in 12-Item Short Form Health Survey (SF-12) Score
timeFrame: Baseline and 3 months post randomization
measure: Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score
timeFrame: Baseline and 3 months post randomization
measure: Change in Self Efficacy for Diabetes
timeFrame: Baseline and 3 months post randomization
measure: Change in Diabetes Health Belief Scale
timeFrame: Baseline and 3 months post randomization
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Dunwoody Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Ambar Kulshreshtha, MD, PhD FAHA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornely RM, Subramanya V, Owen A, McGee RE, Kulshreshtha A. A mixed-methods approach to understanding the perspectives, experiences, and attitudes of a culturally tailored cognitive behavioral therapy/motivational interviewing intervention for African American patients with type 2 diabetes: a randomized parallel design pilot study. Pilot Feasibility Stud. 2022 May 21;8(1):107. doi: 10.1186/s40814-022-01066-4.