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An Emotion-Focused Intervention for Glycemic Control in T2D

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ClinicalTrials.gov Identifier: NCT03553680
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: Emotion-Focused CBT Not Applicable

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,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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Emotion-Focused CBT
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Emotion-Focused Psychosocial Intervention for Improved Glycemic Control in T2D Patients: A Pilot Study
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : October 19, 2018
Estimated Study Completion Date : October 19, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the Score on "Negative Emotional Reactivity" on the Affect Intensity Measure (AIM) Scale. [ Time Frame: Baseline and end-point (about 10-12 weeks). ]
    Intensity of negative emotional reactivity. Range from 6 to 36, higher scores indicate greater intensity of negative emotional reactivity.

  2. Change Score on the "Clarity of Emotion" on the Trait Meta Mood (TMM) scale for emotional intelligence. [ Time Frame: Baseline and end-point (about 10-12 weeks) ]
    Assessment of clarity of emotions. Range from 0 to 44; higher scores indicate greater emotional intelligence.

  3. HbA1c level [ Time Frame: Baseline and end-point (about 10-12 weeks) ]
    HbA1c levels


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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/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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553680


Contacts
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Contact: Emil F Coccaro, MD 773-852-1338 ecoccaro@bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Emil F Coccaro, MD         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Emil F Coccaro, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03553680     History of Changes
Other Study ID Numbers: 17-0635
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No