Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.

Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients With T2D.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Behavioral: Group Emotion Focused Behavioral Intervention (G-EFBI); Behavioral: Group - With Every Heartbeat is Life (G-WEHL)

Detailed 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, 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
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julian Roberts, R.N.; Phone Number: 614-257-2086; Email: julian.roberts@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 score < 2.0 on all DDS subscales.
4. A1c < 7.5 (with hemoglobin in the normal range).
5. PHQ-9 Depression score > 15.
6. Unstable medical co-morbid conditions (e.g., hospitalization in past three months).
7. Presence of a psychotic disorder or an intellectual disability.
8. Initiation of psychotherapy or pharmacotherapy for emotional issues within three months of study entry.
9. Unable to read English.
10. Unable to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Emotion Focused Behavioral Intervention (G-EFBI); Group EFBI (G-EFBI) is a 10-session, 75-minute, program aimed at assisting people with T2D to gain knowledge about emotions and improve their ability to regulate and manage their emotions. G-EFBI begins with discussions regarding the relationship between events, feelings, and behaviors/actions and how this relates to diabetes management. The intervention moves to teaching participants: (1) how to identify emotions and understand their purpose; (2) learn how identifying the physiological/behavioral pattern of their own emotions; (3) learn the importance of recognizing emotions in themselves and in others; (4) learn strategies aimed at helping them to better cope and manage their emotions; (5) learn to use specific emotional restructuring strategies (i.e., reframing, finding the evidence) to change their negative emotional responses to daily stressors and events as it relates to diabetes management.	Behavioral: Group 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.
Active Comparator: G-WEHL; To control for the effect of attention given to participants in G-EFBI that can result in psychosocial improvements, participants will be randomized to either G-EFBI or Group-With Every Heartbeat is Life (G-WEHL). G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease. This intervention has ten 75-minute content sessions covering cardiovascular risk reduction in terms of diet, physical activity, and smoking cessation; the G-WEHL manual is provided in the Clinical Trials Section of this application; G-WEHL has no elements relevant to emotion regulation. The use of WEHL in this study is relevant because cardiovascular disease affects one-third of PWD, is a major cause of mortality (~ 50%), and impact (20-49%) on direct medical costs of T2D.	Behavioral: Group - With Every Heartbeat is Life (G-WEHL); G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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%.	Week 0, Week 5, Week 10 and Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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).	Week 10 and Month 6

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: HbA1c; T2D; Diabetes Distress
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2024H0014; R01DK135948 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic, clinical, and clinical trial data will be acquired from up to 120 individuals with Type 2 Diabetes. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier will be collected for each subject.
• IPD Sharing Time Frame: January 1, 2030
• IPD Sharing Access Criteria: Any relevant health sciences investigator currently appointed at an academic institution.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No