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Diabetes Mellitus, Type 2NCT03562767

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

A study testing Group-based Cognitive Behavioral Intervention and Web-based Cognitive Behavioral Intervention in people with Diabetes Mellitus, Type 2, run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Group-based Cognitive Behavioral Intervention and Web-based Cognitive Behavioral Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
5 Dec 2018to 30 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory Dunwoody Clinic

    Atlanta, Georgia, 30338

Other trials in United States

About this study

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.

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.

Read the 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).

Being tested
Group-based Cognitive Behavioral Intervention, Web-based Cognitive Behavioral Intervention, Usual Care
Keywords
Culturally-Tailored Cognitive Behavior intervention (CT-CB), Family Practice, Diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group-based Cognitive Behavioral InterventionBehavioural

    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 InterventionBehavioural

    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 CareBehavioural

    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.

Study groups in NCT03562767
Study groupRoleWhat they receive
Group-based Cognitive Behavioral InterventionExperimentalSubjects receiving the group-based CT-CB intervention
Receives: Behavioral: Group-based Cognitive Behavioral Intervention
Web-based Cognitive Behavioral InterventionExperimentalSubjects receiving the web based CT-CB intervention
Receives: Behavioral: Web-based Cognitive Behavioral Intervention
Usual CarePlacebo comparatorSubjects receiving usual care from their primary care providers
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months post randomization

  2. 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.

    Measured: 3 months post randomization

Secondary outcomes (7)

  1. Change in Hemoglobin A1c (HbA1C) Level

    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.

    Measured: Baseline and 3 months post randomization

  2. Change in Patient Health Questionnaire (PHQ-9) Score

    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.

    Measured: Baseline and 3 months post randomization

  3. Change in Diabetes Distress Scale (DDS17) Score

    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.

    Measured: Baseline and 3 months post randomization

  4. Change in 12-Item Short Form Health Survey (SF-12) Score

    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.

    Measured: Baseline and 3 months post randomization

  5. Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score

    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.

    Measured: Baseline and 3 months post randomization

  6. Change in Self Efficacy for Diabetes

    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.

    Measured: Baseline and 3 months post randomization

  7. Change in Diabetes Health Belief Scale

    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

    Measured: Baseline and 3 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start5 Dec 2018
  3. Primary completion30 May 2019
  4. Study completion30 May 2019

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three groups of subjects with uncontrolled diabetes Type 2 will be followed longitudinally for 3 months
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562767
Sponsor's protocol ID
IRB00101847
Other IDs
P30DK111024
Status last verified
Jul 2023
First submitted
8 Jun 2018
Last updated
2 Aug 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share the participants data

Publications

  • 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.

    PubMed 35597972

Questions about this trial

What is this clinical trial studying?

A study testing Group-based Cognitive Behavioral Intervention and Web-based Cognitive Behavioral Intervention in people with Diabetes Mellitus, Type 2, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants That Complete the Study Compared to Enrolled (time frame: 3 months post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03562767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.

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