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出境医 / 临床实验 / An Emotion-Focused Intervention for Glycemic Control in T2D

An Emotion-Focused Intervention for Glycemic Control in T2D

Study Description
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.

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, 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Emotion-Focused CBT
Masking: None (Open Label)
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
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : October 19, 2018
Arms and Interventions
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
Primary Outcome Measures :
  1. Change in the ER-Exp Score [ Time Frame: Baseline, mid-point, and end-point (about 10-12 weeks). ]
    ER-Exp: Intensity and lability of negative emotion, higher scores indicate greater native emotionality

  2. Change Score in ER-Skill Score [ Time Frame: Baseline, ,mid-point and end-point (about 10-12 weeks) ]
    Skill at emotional regulation (Clarity and Repair). Lower scores indicate reduced skill at modulating negative emotions

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

  4. Change in Diabetes Distress [ Time Frame: Baseline, mid-point, and end-point (about 10-12 weeks) ]
    Distress at living with and coping with diabetes


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


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-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.
Contacts and Locations

Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Emil F Coccaro, MD University of Chicago
Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE October 20, 2017
Actual Primary Completion Date October 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • Change in the ER-Exp Score [ Time Frame: Baseline, mid-point, and end-point (about 10-12 weeks). ]
    ER-Exp: Intensity and lability of negative emotion, higher scores indicate greater native emotionality
  • Change Score in ER-Skill Score [ Time Frame: Baseline, ,mid-point and end-point (about 10-12 weeks) ]
    Skill at emotional regulation (Clarity and Repair). Lower scores indicate reduced skill at modulating negative emotions
  • Change in HbA1c level [ Time Frame: Baseline, mid-point, and end-point (about 10-12 weeks) ]
    HbA1c levels
  • Change in Diabetes Distress [ Time Frame: Baseline, mid-point, and end-point (about 10-12 weeks) ]
    Distress at living with and coping with diabetes
Original 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
Change in Diabetes Self-Care [ Time Frame: Baseline, mid-point, and end-point (about 10-12 weeks) ]
Self-Care Inventory-Revised: higher scores mean great efforts at self-care.
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-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).
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: None (Open Label)
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 19, 2018
Actual 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-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.
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 information is only displayed when the study is recruiting subjects
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