About this trial
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.
Eligibility criteria
Qualifiers
Male and female adults with documented diagnosis of T2D for at least one year.
Age > 18 years of age.
Diabetes Distress Scale score > 2.0 on any DDS subscale.
A1c > 7.5 (with hemoglobin in the normal range).
Disqualifiers
Male and female adults with documented diagnosis of T2D for less than one year.
Age < 18 years of age.
Diabetes Distress Scale score < 2.0 on all DDS subscales.
A1c < 7.5 (with hemoglobin in the normal range).
Trial design
Treatments tested in this trial
- Group Emotion Focused Behavioral Intervention (G-EFBI)
- Group - With Every Heartbeat is Life (G-WEHL)
Treatment groups
Sponsors and collaborators
Ohio State University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator