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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

Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE October 20, 2017
Estimated Primary Completion Date October 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • 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.
  • 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.
  • HbA1c level [ Time Frame: Baseline and end-point (about 10-12 weeks) ]
    HbA1c levels
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Emotion-Focused Intervention for Glycemic Control in T2D
Official Title  ICMJE An Emotion-Focused Psychosocial Intervention for Improved Glycemic Control in T2D Patients: A Pilot Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Emotion-Focused CBT
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Type2 Diabetes
Intervention  ICMJE Behavioral: Emotion-Focused CBT
10 CBT Sessions to improve emotional regulation and emotional intelligence.
Study Arms  ICMJE
  • Experimental: Emotion-Focused CBT
    Ten CBT sessions with a therapist.
    Intervention: Behavioral: Emotion-Focused CBT
  • No Intervention: Wait List
    Three visits for assessments only over the same time period of the Experimental Arm.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 19, 2018
Estimated Primary Completion Date October 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emil F Coccaro, MD 773-852-1338 ecoccaro@bsd.uchicago.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553680
Other Study ID Numbers  ICMJE 17-0635
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emil F Coccaro, MD University of Chicago
PRS Account University of Chicago
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP