๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-02

Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D. (NCT06912737)

Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients With T2D.

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: Ohio State University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: The Ohio State University Wexner Medical Center โ€” Columbus, Ohio

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • Group Emotion Focused Behavioral Intervention (G-EFBI) (BEHAVIORAL)
  • Group - With Every Heartbeat is Life (G-WEHL) (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • The Ohio State University Wexner Medical Center โ€” Columbus, Ohio

๐Ÿ“ž Contact the Study Coordinator

Phone: (614) 257-2086

Email: julian.roberts@osumc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—