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

NCT06912737 | Not Yet Recruiting DMC

• 2 other identifiers: 2024H0014R01DK135948
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Keywords

T2D; Diabetes Distress; HbA1c

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Emotion Regulation Skill (ER-Skill)

  Week 0, Week 5, Week 10 and Month 6

• Emotion Regulation Experience (ER-Exp)

  Week 0, Week 5, Week 10 and Month 6

• Self-Care Inventory-Revised (SCI-R)

  Week 0, Week 5, Week 10 and Month 6

• Patient Activation Measure (PAM) for Engagement/Motivation

  Week 0, Week 5, Week 10 and Month 6

• PHQ-9 for State Depression

  Week 0, Week 5, Week 10 and Month 6

Study Arms (2)

Group Emotion Focused Behavioral Intervention (G-EFBI)

EXPERIMENTAL

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)

G-WEHL

ACTIVE COMPARATOR

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)

Interventions

Group Emotion Focused Behavioral Intervention (G-EFBI) BEHAVIORAL

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.

Group Emotion Focused Behavioral Intervention (G-EFBI)

Group - With Every Heartbeat is Life (G-WEHL) BEHAVIORAL

G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease.

G-WEHL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• PHQ-9 Depression score \< 15.
• Stable medical co-morbid conditions.
• Absence of a psychotic disorder or an intellectual disability.
• Able to read English.
• Able to give informed consent.

You may not qualify if:

• 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).
• PHQ-9 Depression score \> 15.
• Unstable medical co-morbid conditions (e.g., hospitalization in past three months).
• Presence of a psychotic disorder or an intellectual disability.
• Initiation of psychotherapy or pharmacotherapy for emotional issues within three months of study entry.
• Unable to read English.
• Unable to give informed consent.

Sponsors & Collaborators

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

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Julian Roberts, R.N.

CONTACT

614-257-2086; julian.roberts@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: George T. Harding Professor of Psychiatry & Behavioral Health

Model Details: Half of the study participants will be randomized to G-EFBI and half to G-WEHL.

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: April 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 1, 2030
• Access Criteria: Any relevant health sciences investigator currently appointed at an academic institution.

Locations

US (1)