An Emotion-Focused Intervention for Glycemic Control in T2D



Status:Recruiting
Healthy:No
Age Range:21 - 65
Updated:6/14/2018
Start Date:October 20, 2017
End Date:October 19, 2018
Contact:Emil F Coccaro, MD
Email:ecoccaro@bsd.uchicago.edu
Phone:773-852-1338

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An Emotion-Focused Psychosocial Intervention for Improved Glycemic Control in T2D Patients: A Pilot Study

The primary aim of this proposed project is to collect pilot data using an Emotion Regulation
/ Emotional Intelligence-Focused Psychosocial Intervention to obtain the effect sizes on
hypothesized changes in Emotion Regulation, Emotional Intelligence, and HbA1c values that
will be needed for a more appropriately sized clinical trial for an RO1 submission to the
National Institutes of Health.

Our interest in aberrant Emotional Regulation / Emotional Intelligence in Type 2 Diabetes
stems from observations that while many patients with Type 2 Diabetes have greater incidence
of mood and anxiety (and even anger) disorders than controls, targeting psychiatric
conditions, such as depression, is not sufficient to improve glycemic control in patients
with diabetes. Thus, the key issue for such patients is not what specific psychiatric
disorder they have, but the presence of an impairment in the fundamental regulation of
emotional regulation and in how such individuals modulate their emotional response to
aversive events in their lives (e.g., emotional intelligence), now suggested by a recent
study. As part of a new study,4 we examined the relationship between glycemic control (HbA1c)
and Emotional Regulation and Emotional Intelligence in 100 adult patients with Type 2
Diabetes. We found significant relationships between Emotional Regulation and Emotional
Intelligence and HbA1c levels that accounted for nearly 24% of the variance in HbA1c levels.
These relationships with HbA1c levels remained even after accounting for other relevant
behavioral variables such as depression/anxiety scores and diabetes self-care/literacy
scores. Accordingly, the tendency of an individual to have intense emotional responses
(Emotional Regulation), and/or to have a reduced ability to understand/modulate one's
emotions in order to cope with daily stresses/threats (Emotional Intelligence), may well be
linked with poor glycemic control (HbA1c) in adult patients with Type 2 Diabetes. If so, it
will be important to develop psychosocial methods to improve Emotional Regulation and
Emotional Intelligence in Type 2 Diabetes patients to determine if one can improve aberrant
Emotional Regulation / Emotional Intelligence and HbA1c levels as suggested by treatment
studies showing that such treatment can improve Emotional Intelligence scores with a
sustained reduction in HbA1c levels in Type 2 Diabetes for up to nine months. Supporting
these findings are data from a recent study showing that increasing positive emotion reduces
blood glucose levels, especially in those with poor emotion regulation skills.

Specific Study Objectives:

- Develop an integrated Emotion Regulation / Emotional Intelligence-Focused Psychosocial
Intervention from three (3) existing sources that contain Emotional Regulation and
Emotional Intelligence Psychosocial Intervention elements for the treatment of
behavioral conditions.

- Conduct a pilot study in 10 patients with Type 2 Diabetes with aberrant Emotional
Regulation and Emotional Intelligence and compare treatment outcomes in Emotional
Regulation, Emotional Intelligence, and in HbA1c with 10 patients with Type 2 Diabetes
undergoing treatment as usual.

Inclusion Criteria:

1. Receiving care for T2D at Kovler Diabetes Center, at UCM, or in the community.

2. Documented diagnosis of T2D for at least one year.

3. Age: 21-65 years of age.

4. HbA1c > 7.0 (with hemoglobin in the normal range).

5. ER/EI+ Screen score of > 13 on NER on the AIM and < 11 on COE on the TMM.

6. Stable medical co-morbid conditions.

7. Able to read English.

8. Able to give informed consent.

Exclusion Criteria:

1. Documented diagnosis of T2D less than one year.

2. Age: < 21 or > 65 years of age.

3. HbA1c < 7.0 .

4. ER/EI+ Screen score of < 13 on NER on the AIM and/or > 11 on COE on the TMM.

5. Unstable medical co-morbid conditions.

6. Active psychosis or suicidal/homicidal ideation.

7. Not able to read English.

8. Not able to give informed consent.
We found this trial at
1
site
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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