Group Emotion-Focused Behavioral Intervention for Type 2 Diabetes
This study is testing a group-based emotional support program called Group Emotion Focused Behavioral Intervention (G-EFBI) for people with Type 2 Diabetes (T2D) who have high diabetes distress and A1c levels (a measure of blood sugar). It aims to help you understand and manage your emotions better. Another group will receive an educational program called "With Every Heartbeat is Life" (G-WEHL) about heart health. Researchers want to see if G-EFBI can reduce diabetes distress and improve A1c levels. You might be able to join if you are an adult with T2D for at least one year, have an A1c above 7.5%, and a certain level of diabetes distress. The study plans to enroll 120 participants.
- Study design
- This study is an interventional trial that will randomize up to 120 participants into one of two groups. It is an early-stage project to gather information on feasibility and effectiveness.
- What's involved
- You would attend 10 sessions, each lasting 75 minutes, and have 16 visits in total. These visits include an initial assessment and follow-up assessments over 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your diabetes distress and A1c levels will be measured at Week 0, Week 5, Week 10, and Month 6 after starting the intervention.
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Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Diabetes Distress Scale (DDS)Week 0, Week 5, Week 10 and Month 6
The Diabetes Distress Scale (DDS) will be used to assess psychological distress associated with the care and management of T2D; assessment of DD is critical for T2D intervention studies. The 17-item DDS has four subscales: regimen-related distress, emotional burden, physician distress, and interpersonal distress. Respondents have six options for each item ranging from "1" (not a problem) to "6" (a very serious problem). Mean Scores \> 2.0 are at threshold for clinically meaningful DD.
- HbA1c LevelWeek 0, Week 5, Week 10 and Month 6
A1c is measured at Visit #1 (Pre-Intervention) Visit #8 (Mid-Point), Visit #14 (After End of Intervention) and at Visit #15 (Six Month Follow-Up). A DCA Vantage (Siemens) "point of contact" (POC) instrument will be used for A1c levels. The research assistant will be trained in obtaining the fingerstick sample by the PI/Co-I (Drs. Coccaro and Joseph) and in how to operate the instrument. Our POC method displays a "unity" correlation with commercial assays (Roche Labs): r =.993 (p \< .001) and bias of 0.03%.