Study Stopped
A control group was intended to be added to the study, but the study team decided not complete this additional research with the pandemic. Additional funds were also not available to enroll a new control group and thus, the study was terminated.
Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes
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.
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Dec 2018
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedStudy Start
First participant enrolled
December 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedResults Posted
Study results publicly available
January 3, 2022
CompletedAugust 2, 2023
July 1, 2023
6 months
June 8, 2018
October 22, 2021
July 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants That Complete the Study Compared to Enrolled
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.
3 months post randomization
Percentage of Participants That Are Enrolled and Attend the Study the Study Sessions Compared to Enrolled
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.
3 months post randomization
Secondary Outcomes (7)
Change in Hemoglobin A1c (HbA1C) Level
Baseline and 3 months post randomization
Change in Patient Health Questionnaire (PHQ-9) Score
Baseline and 3 months post randomization
Change in Diabetes Distress Scale (DDS17) Score
Baseline and 3 months post randomization
Change in 12-Item Short Form Health Survey (SF-12) Score
Baseline and 3 months post randomization
Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score
Baseline and 3 months post randomization
- +2 more secondary outcomes
Study Arms (3)
Group-based Cognitive Behavioral Intervention
EXPERIMENTALSubjects receiving the group-based CT-CB intervention
Web-based Cognitive Behavioral Intervention
EXPERIMENTALSubjects receiving the web based CT-CB intervention
Usual Care
PLACEBO COMPARATORSubjects receiving usual care from their primary care providers
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- Age: 18 years or older
- Fluency in English
- African American
- HbA1C\>8%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emory Dunwoody Clinic
Atlanta, Georgia, 30338, United States
Related Publications (1)
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.
PMID: 35597972DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated. A control group was intended to be added for the study, but the study team decided not to complete this additional research due to the COVID pandemic. Additional funds were not available to enroll the control group.
Results Point of Contact
- Title
- Dr. Ambar Kulshreshtha
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Ambar Kulshreshtha, MD, PhD FAHA
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Family and Preventive Medicine
Study Record Dates
First Submitted
June 8, 2018
First Posted
June 19, 2018
Study Start
December 5, 2018
Primary Completion
May 30, 2019
Study Completion
May 30, 2019
Last Updated
August 2, 2023
Results First Posted
January 3, 2022
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
No plan to share the participants data