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

NCT ID: NCT06912737

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-01-31

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.

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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Group Emotion Focused Behavioral Intervention (G-EFBI)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Emil Coccaro

George T. Harding Professor of Psychiatry & Behavioral Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Central Contacts

Julian Roberts, R.N.

Role: CONTACT

julian.roberts@osumc.edu

614-257-2086

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK135948

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024H0014

Identifier Type: -

Identifier Source: org_study_id