Emotion-Focused Behavioral Intervention for Type 2 Diabetes

Overseen By Julian Roberts, R.N.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Psychotic disorder, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new group program designed to help individuals with Type 2 Diabetes manage their emotions, potentially improving overall diabetes management. The trial tests whether the Group Emotion-Focused Behavioral Intervention (G-EFBI) can reduce diabetes-related stress and improve blood sugar control. Participants will join either this group program or another educational program focused on heart health. The trial seeks individuals who have had Type 2 Diabetes for at least one year, feel stressed about managing their diabetes, and struggle to control their blood sugar levels. As an unphased trial, this study offers a unique opportunity to explore innovative strategies for emotional and diabetes management.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the focus is on emotional and behavioral intervention.

What prior data suggests that this intervention is safe for people with Type 2 Diabetes?

Research has shown that group therapy, such as the Group Emotion-Focused Behavioral Intervention (G-EFBI), can reduce emotional distress and improve the quality of life for people with diabetes. These programs focus on understanding and managing emotions and are generally well-received without causing negative side effects. Since the trial does not test a drug or medical device, the risk of harm remains very low. Instead, it employs group sessions to help individuals cope with the emotional challenges of managing diabetes. Overall, this approach is considered safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Group Emotion-Focused Behavioral Intervention (G-EFBI) for Type 2 Diabetes because it shifts the focus from purely physical treatments to addressing the emotional aspects of diabetes management. Unlike traditional treatments that primarily focus on medication and lifestyle changes like diet and exercise, G-EFBI aims to help individuals understand and regulate their emotions, which can significantly impact diabetes management. This intervention's unique approach involves teaching participants to identify, understand, and restructure their emotional responses, providing tools to handle stressors that can affect their condition. By potentially improving emotional regulation, G-EFBI could enhance overall diabetes management and quality of life, offering a fresh perspective in treating Type 2 Diabetes.

What evidence suggests that the Group Emotion-Focused Behavioral Intervention (G-EFBI) might be an effective treatment for Type 2 Diabetes?

Research has shown that an Emotion-Focused Behavioral Intervention (EFBI), which participants in this trial may receive, can help people with Type 2 Diabetes (T2D) by reducing emotional stress and improving blood sugar levels. One study found moderate improvements in both diabetes-related stress and A1c levels, an important measure of blood sugar, in patients who participated in this program. Another study found that group therapy focused on managing emotions improved self-care and quality of life for T2D patients. These findings suggest that EFBI helps by teaching better ways to handle emotions, making it easier to follow medical advice and control blood sugar. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with Type 2 Diabetes who struggle to keep their A1c levels below 7.0%, possibly due to emotional regulation issues that lead to Diabetes Distress (DD). Participants should have difficulty coping with diabetes self-care and experience high stress related to their condition.

Inclusion Criteria

I have been diagnosed with type 2 diabetes for at least a year.

PHQ-9 Depression score < 15

Absence of a psychotic disorder or an intellectual disability

Exclusion Criteria

I was diagnosed with type 2 diabetes less than a year ago.

I am under 18 years old.

My A1c is below 7.5 with normal hemoglobin levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preparation

Preparation session prior to starting group intervention

1 week

1 visit (in-person)

Treatment

Participants undergo 10 sessions of either G-EFBI or G-WEHL intervention

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Group Emotion-Focused Behavioral Intervention (G-EFBI)

Trial Overview The study tests a Group Emotion-Focused Behavioral Intervention (G-EFBI) against an 'Attentional Control' intervention, With Every Heartbeat is Life (G-WEHL), aiming to improve emotional regulation, reduce DD, and lower A1c levels in participants.

How Is the Trial Designed?

Group I: Group Emotion Focused Behavioral Intervention (G-EFBI) Experimental Treatment 1 Intervention

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 II: G-WEHL Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A family-based psychological intervention significantly reduced A1C levels in patients with poorly controlled type 2 diabetes, with the intervention group showing an average A1C of 8.4% compared to 8.8% in the control group after 6 months.

The intervention was particularly effective for patients with the highest baseline A1C levels (over 9.5%), leading to notable improvements in diabetes-related beliefs, psychological well-being, diet, exercise, and family support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological family intervention for poorly controlled type 2 diabetes. Keogh, KM., Smith, SM., White, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06912737

Group Emotion-Focused Behavioral Intervention for ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9133204/

Diabetes Distress, Emotional Regulation, HbA1c in People ... Study II tested an emotion-focused behavioral intervention in patients with Type 2 diabetes compared to treatment as usual and found medium sized reductions in ...

3. withpower.com withpower.com/trial/phase-diabetes-mellitus-8-2025-cc664

Emotion-Focused Behavioral Intervention for Type 2 ... Research shows that group therapy, like Mindfulness-Based Cognitive Therapy, can help reduce emotional distress and improve quality of life for people with ...

4. brieflands.com brieflands.com/journals/ijpbs/articles/114224

The Effectiveness of Acceptance-based Emotion ... Our results showed that acceptance-based emotion regulation group therapy improved self-care, quality of life, and HbA1c in type 2 diabetic patients, so it can ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1056872722000794

Effectiveness of cognitive behavioral therapy-based ... The findings of this scoping review demonstrate the positive impact of CBT on depressive symptoms and other psychological aspects of everyday life in patients ...

6. reporter.nih.gov reporter.nih.gov/project-details/11134676

Tailoring Diabetes Support to Social Contexts for Adults ... Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients with T2D. 499, 5R01DK135948-02Project ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0953620524002413

A group-based intervention for diabetes-related emotional ... This pilot study demonstrated that 25 % of the investigated emerging adults with T1D experienced DD (PAID-20≥30) associated with four clinical factors.

8. diabetesjournals.org diabetesjournals.org/care/article/45/12/2976/147620/Randomized-Controlled-Trial-of-a-Digital

Randomized, Controlled Trial of a Digital Behavioral ... Meta-analyses of randomized trials of CBT-based interventions in patients with diabetes have reported HbA1c reductions ranging from 0.3 to 1.6% ...