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

NCT ID: NCT03562767

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2019-05-30

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).

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group-based Cognitive Behavioral Intervention

Subjects receiving the group-based CT-CB intervention

Group Type: EXPERIMENTAL

Group-based Cognitive Behavioral Intervention

Intervention Type: BEHAVIORAL

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

Group Type: EXPERIMENTAL

Web-based Cognitive Behavioral Intervention

Intervention Type: BEHAVIORAL

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

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ambar Kulshreshtha

Assistant Professor, Department of Family and Preventive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ambar Kulshreshtha, MD, PhD FAHA

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Dunwoody Clinic

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35597972 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30DK111024

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00101847

Identifier Type: -

Identifier Source: org_study_id