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.
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, acceptability, and preliminary efficacy data. Participants will be randomized to ten 75-minute sessions of G-EFBI or of the Attentional Control Group Intervention, "With Every Heartbeat Is Life" (WEHL). WEHL is a psychoeducational intervention designed to increase awareness and prevention of cardiovascular disease and contains no ER related content. Study groups of patients with T2D will be recruited as above. This study will have 16 visits. Visit #1. Informed Consent and final assessment for study entry. Study participants must have a current A1c \> 7.5%, a current DDS score \> 2.0 on any DDS subscale, and be medically stable (e.g., without chronic renal failure). Assessments are listed below: 1. Glycemic Control. A1c using a DCA Vantage (Siemens) "point of contact" (POC) instrument. Blood (\< 1 cc) is taken from a fingerstick. The total number of finger sticks in this study is four for a total blood collection volume of \< 5 cc. 2. Diabetes Related Distress. Diabetes Distress Scale (DDS) 3. ER-Experience and ER-Skill. ER-Experience from the Affect Lability Scales (ALS); ER-Skill from the Trait-Meta-Mood (TMM) questionnaire. 4. Diabetes Self-Care and Engagement/Motivation. The Self-Care Inventory-Revised (SCI-R) and the Patient Activation Measure (PAM). 5. Depression, Anxiety, Stress, and Quality of Life (Q-LES-Q). State Depression/State Anxiety be assessed by PHQ-9 and GAD-7; Psychosocial stress assessed by the Perceived Stress Scale (PSS); Q-LES-Q will be assessed by Quality-of-Life Experience and Satisfaction. Visit #2: This is a 30-60 minute preparation session prior to the participant starting group intervention. Visit #3-7: Start G-EFBI or G-WEHL Sessions 1-5. Visit #8 (Mid-Point Assessment): A1c / DDS / AIM / ALS / TMM / SCI-R / PHQ-9 / GAD-7 / PSS / QOL. Visits 10-14: G-EFBI or G-WEHL Sessions 6-10. Visit #15 (End-Point Assessment): A1c / DDS / AIM / ALS / TMM / SCI-R / PHQ-9 / GAD-7 / PSS / Q-LES-Q. Visits #16 Post-Rx Assessment at Six Month F/U). Same as Visit #15.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease.
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
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.
Time frame: Week 0, Week 5, Week 10 and Month 6
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%.
Time frame: Week 0, Week 5, Week 10 and Month 6
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.
Time frame: Week 0, Week 5, Week 10 and Month 6
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.
Time frame: Week 0, Week 5, Week 10 and Month 6
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.
Time frame: Week 0, Week 5, Week 10 and Month 6
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.
Time frame: Week 0, Week 5, Week 10 and Month 6
PHQ-9 for State Depression
State Depression will be assessed by commonly used PHQ-9 which is a nine-item screening assessment of current symptoms of depression.
Time frame: Week 0, Week 5, Week 10 and Month 6
GAD-7 for State Anxiety
State Anxiety will be assessed by GAD-7, a commonly used 7-item screening measure of state anxiety.
Time frame: Week 0, Week 5, Week 10 and Month 6
Perceived Stress Scale (PSS) for Perceived Psychosocial Stress
Perceived psychosocial stress will be assessed by the Perceived Stress Scale (Past Month). This is a ten item scale.
Time frame: Week 0, Week 5, Week 10 and Month 6
Quality of Life Experience and Satisfaction (Q-LES-Q)
Q=LES-Q is a 16-item QOL scale that assesses quality of life experience and satisfaction across several domains.
Time frame: Week 0, Week 5, Week 10 and Month 6
Assessment of Acceptance, Appropriateness, and Feasibility of Intervention.
Acceptability, Appropriateness, and Feasibility of Intervention (AAFI), as developed by Weiner et al. will be done at post-intervention (end of trial and six month follow-up). The AAFI comprises of three (3) four item Likert scale (1-5: strongly disagree to strongly agree) questionnaires with good internal (α's: 0.85 to 0.91) and test-retest (r=0.73 to 0.88), reliability known-groups validity, and sensitivity to change in both directions. These are Acceptability of Intervention Measure AIM), Intervention Appropriate Measure (IAM), and Feasibility of Intervention Measure (FIM).
Time frame: Week 10 and Month 6
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