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.
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).
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).
Parallel
Group Emotion Focused Behavioral Intervention (G-EFBI)
BehavioralGroup 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.
Group - With Every Heartbeat is Life (G-WEHL)
BehavioralG-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease.
Diabetes Distress Scale (DDS)
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 Level
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%.
Emotion Regulation Skill (ER-Skill)
The "Clarity of Emotion" and "Repair of Emotion" scores from the Trait Meta-Mood (TMM) scale will constitute ER-Skill score.
Emotion Regulation Experience (ER-Exp)
The "Negative Emotional Intensity" score from the Affect Intensity Measure (AIM) and "Anxiety/Depression Lability" score from the Affect Lability Scales (ALS) will constitute the ER-Exp score.
Self-Care Inventory-Revised (SCI-R)
The Self-Care Inventory-Revised (SCI-R), included in our previous studies, will be used to assesses how well patients have followed self-care recommendations in the past month.
Patient Activation Measure (PAM) for Engagement/Motivation
The Patient Activation Measure (PAM), assessing skill/confidence for self-management will be used to assess engagement/motivation.
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Ohio State University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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