Emotion-Focused Behavioral Intervention for Type 2 Diabetes

Recruiting in Columbus (<10 mi)

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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Emotion-Focused Behavioral Intervention for Type 2 Diabetes?

Research shows that group therapy, like Mindfulness-Based Cognitive Therapy, can help reduce emotional distress and improve quality of life for people with diabetes. Additionally, behaviorally oriented group therapy has been effective in helping patients cope with fears related to diabetes complications, suggesting that similar emotion-focused treatments could be beneficial. ^{1 2 3 4 5}

How is the Emotion-Focused Behavioral Intervention (G-EFBI) treatment different from other treatments for Type 2 diabetes?

The Emotion-Focused Behavioral Intervention (G-EFBI) is unique because it targets emotional aspects of living with Type 2 diabetes, aiming to reduce diabetes distress by focusing on emotional regulation and support, unlike traditional treatments that primarily focus on medication and physical health management. ^{1 3 6 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

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

My other health conditions are under control.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The effects of a mindfulness-based intervention on emotional distress, quality of life, and HbA(1c) in outpatients with diabetes (DiaMind): a randomized controlled trial. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Emotion regulation contributes to the development of diabetes distress among adults with type 1 diabetes. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Coping with fear of long-term complications in diabetes mellitus: a model clinical program. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Psychological family intervention for poorly controlled type 2 diabetes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The effectiveness of an emotion-focused educational programme in reducing diabetes distress in adults with Type 2 diabetes mellitus (VEMOFIT): a cluster randomized controlled trial. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Stress management training as related to glycemic control and mood in adults with Type 1 diabetes mellitus. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Cognitive behavioural group training (CBGT) for patients with type 1 diabetes in persistent poor glycaemic control: who do we reach? [2018]