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

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.

Time frame: 3 months post randomization

Population: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated

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.

Time frame: 3 months post randomization

Population: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.

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.

Time frame: Baseline and 3 months post randomization

Population: There was an error in data collection forms provided to participants, which made these questionnaires unusable for data analysis.

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.

Time frame: Baseline and 3 months post randomization

Population: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.

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

Time frame: Baseline and 3 months post randomization

Population: This survey was not administered to participants.

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.

Time frame: Baseline and 3 months post randomization

Population: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.

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.

Time frame: Baseline and 3 months post randomization

Population: The A1C results may be affected by variations in point of care vs regular blood testing and the timing of follow up for participants. Data is included for participants who completed more than 65% of the intervention sessions.

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.

Time frame: Baseline and 3 months post randomization

Population: A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated

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.

Time frame: Baseline and 3 months post randomization