An Emotion-Focused Intervention for Glycemic Control in T2D

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-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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Behavioral: Emotion-Focused CBT

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).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotion-Focused CBT; Ten CBT sessions with a therapist.	Behavioral: Emotion-Focused CBT; 10 CBT Sessions to improve emotional regulation and emotional intelligence.
No Intervention: Wait List; Three visits for assessments only over the same time period of the Experimental Arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the ER-Exp Score	ER-Exp: Intensity and lability of negative emotion, higher scores indicate greater native emotionality	Baseline, mid-point, and end-point (about 10-12 weeks).
Change Score in ER-Skill Score	Skill at emotional regulation (Clarity and Repair). Lower scores indicate reduced skill at modulating negative emotions	Baseline, ,mid-point and end-point (about 10-12 weeks)
Change in HbA1c level	HbA1c levels	Baseline, mid-point, and end-point (about 10-12 weeks)
Change in Diabetes Distress	Distress at living with and coping with diabetes	Baseline, mid-point, and end-point (about 10-12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes Self-Care	Self-Care Inventory-Revised: higher scores mean great efforts at self-care.	Baseline, mid-point, and end-point (about 10-12 weeks)

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Emil F Coccaro, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): October 19, 2018
• Study Completion (Actual): October 19, 2018

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 17-0635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No