Clinical trial NCT03553680: An Emotion-Focused Intervention for Glycemic Control in T2D
Official title: An Emotion-Focused Psychosocial Intervention for Improved Glycemic Control in T2D Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Emotion-Focused CBT
Primary purpose: TREATMENT

Brief summary: The primary aim of this proposed project is to collect pilot data using an Emotion-Focused CBT Psycho-social Intervention i individuals with T2D to obtain the effect sizes on hypothesized changes in Negative Emotionality, Diabetes Distress, and HbA1c values that will be needed for a more appropriately sized clinical trial for an RO1 submission to the National Institutes of Health.

Detailed description: 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, we examined the relationship between glycemic control (HbA1c) and Emotional Experience (ER-Exp) and Skill at Emotional Regulation (ER-Skill) in 100 adult patients with Type 2 Diabetes. We found significant relationships between ER-Exp and ER-Skill 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 (higher scores on ER-Exp), and/or to have a reduced ability to understand/modulate one's emotions in order to cope with daily stresses/threats (lower scores on ER-Skill), may well be linked with poor glycemic control (HbA1c) in adult patients with Type 2 Diabetes. If so, it will be important to develop psycho-social methods to improve ER-Exp and DR-Skill in Type 2 Diabetes patients to determine if one can improve aberrant Emotional Regulation (ER-Exp/ER-Skill), Diabetes Distress (DD), and HbA1c (A1c) levels as suggested by treatment studies showing that such treatment can improve ER-Skill with a sustained reduction in A1c 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 (and increasing negative emotion increases) blood glucose levels, especially in those with poor emotion regulation skills.

Specific Study Objectives:

* Develop an integrated Emotion - Focused Psycho-social EF-CBT) from three (3) existing sources that contain elements to improve ER-Exp and ER-Skill.
* Conduct a pilot study in 10 patients with Type 2 Diabetes with aberrant ER-ER-Exp/ER-Skill and compare treatment outcomes in emotionality, diabetes distress, and in A1c levels with 10 patients with Type 2 Diabetes undergoing treatment as usual (TAU).

Eligibility criteria: 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-Exp Screen score of \> 29 and/or ER-Skill Screen score \< 44.
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-Exp screen score of \< 29 and ER-Skill score =/\> 44.
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.

Primary outcomes:
measure: Change in the ER-Exp Score
timeFrame: Baseline, mid-point, and end-point (about 10-12 weeks).
measure: Change Score in ER-Skill Score
timeFrame: Baseline, ,mid-point and end-point (about 10-12 weeks)
measure: Change in HbA1c level
timeFrame: Baseline, mid-point, and end-point (about 10-12 weeks)
measure: Change in Diabetes Distress
timeFrame: Baseline, mid-point, and end-point (about 10-12 weeks)
Secondary outcomes:
measure: Change in Diabetes Self-Care
timeFrame: Baseline, mid-point, and end-point (about 10-12 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Emil F Coccaro, MD
role: PRINCIPAL_INVESTIGATOR
References: