Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients With T2D.
Ohio State University
Summary
T2D is a major public health problem and is currently the 7th leading cause of death in the US. Despite a range of efficacious treatments, less than 50% of patients achieve a glycemic target of A1c \< 7.0%, suggesting that this is due to difficulty with following medical regimens to reduce A1C levels. While a range of factors have been identified in this regard, we posit that a barrier to treatment are broad difficulty with emotional regulation that are not diagnosis-specific but lead to Diabetes Distress (DD) and difficulty in coping with medical regimens, and other aspects of diabetes self-care, in the context of the psychosocial stressors associated with T2D. Extant data suggests that sub-optimal emotional regulation (experience of intense emotion and skill at regulating emotion) is related to elevated DD and A1c levels, and that an Emotion-Focused Behavioral Intervention (EFBI) can reduce both DD and A1c levels in PWD with T2D. In this project we seek to take our one-to-one intervention, now adapted to a group intervention (G-EFBI) and collect feasibility, acceptability, and preliminary efficacy data to determine if G-EFBI is a feasible, acceptable and, possibly, efficacious intervention compared to an "Attentional Control" intervention in PWD with T2D and elevated DD and A1c levels.
Description
This is an early-stage treatment development project proposing to conduct a modest randomized clinical trial of Group EFBI, vs. a Group Attentional Control Intervention, to collect feasibility, acceptability, and preliminary efficacy data in study participants with poorly controlled T2D (A1c \> 7.5) and high Diabetes Distress Scale (DDS) scores (= or \> 2 on any DDS subscale). This study will seek to study up to one hundred and twenty (120) study participants with T2D and elevated A1c and DDS scores will be recruited for about twelve (12) groups of seven to ten (7-10) to obtain feasibility, ac…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and female adults with documented diagnosis of T2D for at least one year. 2. Age \> 18 years of age. 3. Diabetes Distress Scale score \> 2.0 on any DDS subscale. 4. A1c \> 7.5 (with hemoglobin in the normal range). 5. PHQ-9 Depression score \< 15. 6. Stable medical co-morbid conditions. 7. Absence of a psychotic disorder or an intellectual disability. 8. Able to read English. 9. Able to give informed consent. Exclusion Criteria: 1. Male and female adults with documented diagnosis of T2D for less than one year. 2. Age \< 18 years of age. 3. Diabetes Distress Scale…
Interventions
- BehavioralGroup Emotion Focused Behavioral Intervention (G-EFBI)
Group EFBI (G-EFBI) is aimed at assisting people with T2D to gain knowledge about emotions and improve their ability to regulate and manage their emotions.
- BehavioralGroup - With Every Heartbeat is Life (G-WEHL)
G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease.
Location
- The Ohio State University Wexner Medical CenterColumbus, Ohio