Emotional Awareness and Expression Therapy for Prediabetes

Study Overview
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Brief Summary
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This feasibility study seeks to develop and pilot test Emotional Awareness and Expression Therapy as a possible treatment for people with prediabetes.

Detailed Description
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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.

Official Title
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Examining the Effect of a Novel Stress Reduction Intervention no the Control of Prediabetes: A Feasibility Study

Conditions
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PreDiabetes

Intervention / Treatment
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* Behavioral: Modified EAET for prediabetes


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified EAET for Prediabetes<br>Small groups of people with prediabetes will meet for 4, weekly, 2-hour sessions by telehealth, and will engage in modified EAET for prediabetes | Behavioral: Modified EAET for prediabetes<br>* Attempts to reduce stress and improve health behavior by engaging in emotional awareness and expression leading to changes in interpersonal relationships and health behavior<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Hemoglobin A1c from venous blood | Change from baseline to 3-month follow-up and 6-month follow-up | 
| C-peptide | venous blood surrogate marker of insulin levels | Change from baseline to 3-month follow-up and 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | Psychological stress (scores from 0 to 40; higher scores indicate more perceived stress) | Change from baseline to 3-month follow-up and 6-month follow-up | 
| Body mass index | Measure of overweight / obesity | Change from baseline to 3-month follow-up and 6-month follow-up | 
| Health behavior | Self-reported exercise and diet over the past week | Change from baseline to 3-month follow-up and 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress reduction, Emotional Awareness and Expression Therapy