NCT06912737Not yet recruiting
Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.
Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients With T2D.
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 27 Dec 2024
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Ohio State University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06912737
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Sept 2025 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes Distress Scale score \< 2.0 on all DDS subscales.
- Unstable medical co-morbid conditions (e.g., hospitalization in past three months).
- Presence of a psychotic disorder or an intellectual disability.
Lab values
- A1c \< 7.5 (with hemoglobin in the normal range).
Age
- Age \< 18 years of age.
Other
- Male and female adults with documented diagnosis of T2D for less than one year.
- PHQ-9 Depression score \> 15.
- Initiation of psychotherapy or pharmacotherapy for emotional issues within three months of study entry.
- Unable to read English.
- Unable to give informed consent.
Who the study is looking for
- Male and female adults with documented diagnosis of T2D for at least one year.
- Age \> 18 years of age.
- Diabetes Distress Scale score \> 2.0 on any DDS subscale.
- A1c \> 7.5 (with hemoglobin in the normal range).
- PHQ-9 Depression score \< 15.
- Stable medical co-morbid conditions.
- Absence of a psychotic disorder or an intellectual disability.
- Able to read English.
- Able to give informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.