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

Conditions

• T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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 - With Every Heartbeat is Life (G-WEHL) — BEHAVIORAL
  G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease.

Study Details

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.

Key Dates

Start date

Sep 1, 2025

Status verified

Apr 2025

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Diabetes Distress Scale (DDS) [ Time Frame: Week 0, Week 5, Week 10 and Month 6 ]

Central Contacts

• Julian Roberts, R.N.
  614-257-2086
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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