Emotional Awareness and Expression Therapy for Prediabetes
Primary Purpose
PreDiabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified EAET for prediabetes
Sponsored by
About this trial
This is an interventional treatment trial for PreDiabetes focused on measuring Stress reduction, Emotional Awareness and Expression Therapy
Eligibility Criteria
Inclusion Criteria:
- Affiliated with Wayne State University (faculty, staff, student, or family member/friend thereof)
- HbA1C value of 5.7% to 6.4%
- overweight or obese (≥25 kg/m2) Also, if over ≥ 18 and < 45 years of age must have at least one of the following: a) physical inactivity, b) close family history of diabetes, c) history of hyperlipidemia, d) history of hypertension, e) history of gestational diabetes, and/or f) from high risk race groups (e.g., African American, Latino, Native American, and pacific Islander).
Exclusion Criteria:
- Confirmed history of Type 2 Diabetes
- have prediabetes being treated pharmacologically
- pregnant
- taking medications that affect blood glucose (e.g., corticosteroids)
- chronic depression or major psychotic disorder
- any comorbidities that limit survival or ability to tolerate the intervention (Cushing's, cancer treatment, asthma with inhaled corticosteroids, unstable CAD or MI in last 6 months, CHF, COPD requiring oxygen, chronic kidney disease)
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modified EAET for Prediabetes
Arm Description
Small groups of people with prediabetes will meet for 4, weekly, 2-hour sessions by telehealth, and will engage in modified EAET for prediabetes
Outcomes
Primary Outcome Measures
HbA1c
Hemoglobin A1c from venous blood
C-peptide
venous blood surrogate marker of insulin levels
Secondary Outcome Measures
Perceived Stress Scale
Psychological stress (scores from 0 to 40; higher scores indicate more perceived stress)
Body mass index
Measure of overweight / obesity
Health behavior
Self-reported exercise and diet over the past week
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05344196
Brief Title
Emotional Awareness and Expression Therapy for Prediabetes
Official Title
Examining the Effect of a Novel Stress Reduction Intervention no the Control of Prediabetes: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This feasibility study seeks to develop and pilot test Emotional Awareness and Expression Therapy as a possible treatment for people with prediabetes.
Detailed Description
Prediabetes is a clinical condition in which hemoglobin A1C is between 5.6 and 6.4, and is usually associated with being overweight, poor diet, limited exercise, and psychological stress. This condition develops in to Type II diabetes in many people, and interventions to prevent such progression are needed. Because stress can directly negative impact blood glucose metabolism and can indirectly affect it through unhealthy behaviors (e.g., diet, exercise), it may be possible to reduce stress and improve clinical outcomes. Although most stress management approaches help people to calm their physiology and reduce their negative emotions, another approach to stress treatment is to help people disclose emotionally difficult experiences, become aware of and express their emotions, and change interpersonal relationships by becoming more assertive as well as more open/connected.
Emotional Awareness and Expression Therapy (EAET) is an approach to stress reduction that uses these principles and it has been shown to be effective for somatic symptom disorders like chronic pain. In this study, we will adapt EAET to the prediabetes context and test its feasibility, acceptability and initial efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
Stress reduction, Emotional Awareness and Expression Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Several cohorts of people with prediabetes will be given the treatment and tracked with respect to outcomes from before to after treatment and follow-up
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified EAET for Prediabetes
Arm Type
Experimental
Arm Description
Small groups of people with prediabetes will meet for 4, weekly, 2-hour sessions by telehealth, and will engage in modified EAET for prediabetes
Intervention Type
Behavioral
Intervention Name(s)
Modified EAET for prediabetes
Intervention Description
Attempts to reduce stress and improve health behavior by engaging in emotional awareness and expression leading to changes in interpersonal relationships and health behavior
Primary Outcome Measure Information:
Title
HbA1c
Description
Hemoglobin A1c from venous blood
Time Frame
Change from baseline to 3-month follow-up and 6-month follow-up
Title
C-peptide
Description
venous blood surrogate marker of insulin levels
Time Frame
Change from baseline to 3-month follow-up and 6-month follow-up
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
Psychological stress (scores from 0 to 40; higher scores indicate more perceived stress)
Time Frame
Change from baseline to 3-month follow-up and 6-month follow-up
Title
Body mass index
Description
Measure of overweight / obesity
Time Frame
Change from baseline to 3-month follow-up and 6-month follow-up
Title
Health behavior
Description
Self-reported exercise and diet over the past week
Time Frame
Change from baseline to 3-month follow-up and 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Affiliated with Wayne State University (faculty, staff, student, or family member/friend thereof)
HbA1C value of 5.7% to 6.4%
overweight or obese (≥25 kg/m2) Also, if over ≥ 18 and < 45 years of age must have at least one of the following: a) physical inactivity, b) close family history of diabetes, c) history of hyperlipidemia, d) history of hypertension, e) history of gestational diabetes, and/or f) from high risk race groups (e.g., African American, Latino, Native American, and pacific Islander).
Exclusion Criteria:
Confirmed history of Type 2 Diabetes
have prediabetes being treated pharmacologically
pregnant
taking medications that affect blood glucose (e.g., corticosteroids)
chronic depression or major psychotic disorder
any comorbidities that limit survival or ability to tolerate the intervention (Cushing's, cancer treatment, asthma with inhaled corticosteroids, unstable CAD or MI in last 6 months, CHF, COPD requiring oxygen, chronic kidney disease)
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Emotional Awareness and Expression Therapy for Prediabetes
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