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NCT06912737 · ClinicalTrials.gov registry record · NA
Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.
A NA study, sponsored by Ohio State University.
- Not yet
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT06912737: Clinical Trial NA study, sponsored by Ohio State University.
NCT06912737 is a NA study that has not yet begun recruiting, run by Ohio State University. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06912737, a NA study, has not yet begun recruiting, sponsored by Ohio State University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
The Diabetes Distress Scale (DDS) will be used to assess psychological distress associated with the care and management of T2D; assessment of DD is critical for T2D intervention studies. The 17-item DDS has four subscales: regimen-related distress, emotional burden, physician distress, and interpersonal distress. Respondents have six options for each item ranging from "1" (not a problem) to "6" (a very serious problem). Mean Scores \> 2.0 are at threshold for clinically meaningful DD.
Interventions
- BEHAVIORAL Group Emotion Focused Behavioral Intervention (G-EFBI)
- BEHAVIORAL Group - With Every Heartbeat is Life (G-WEHL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-09-01 |
| Est. Completion | 2028-01-31 |
| Phase | NA |
What is known before NCT06912737 opens enrollment
NCT06912737 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Group Emotion Focused Behavioral Intervention (G-EFBI) is the first listed.
NCT06912737 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06912737 about?
NCT06912737 is a clinical study titled "Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.". 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 level...
What is the current status of trial NCT06912737?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-09-01. Estimated completion is 2028-01-31.
What interventions are being tested in trial NCT06912737?
The interventions under investigation include: Group Emotion Focused Behavioral Intervention (G-EFBI) (BEHAVIORAL), Group - With Every Heartbeat is Life (G-WEHL) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06912737?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06912737's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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