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

Clinical Trial ID: NCT03562767

Description

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.

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).


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

  • Start Date

    2018-12-05

  • Last Updated

    2019-01-30

  • Sponsor

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

  • Condition Name

    Diabetes Mellitus, Type 2

Learn about this trial.

Check the eligibility requirements, study details, and more.

Related Trials

Different trials target different symptoms, condition types, and patients. Learn more about other emergeing treatments being investigated now.