Emotional Awareness and Expression Therapy for Prediabetes

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

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

Study Overview

• Status: Recruiting
• Conditions: PreDiabetes
• Intervention / Treatment: Behavioral: Modified EAET for 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Albdour, PhD, RN; Phone Number: 313-577-0151; Email: eg1130@wayne.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Wayne State University
      • Sub-Investigator: Mark A. Lumley, Ph.D.
      • Principal Investigator: Maha Albdour, Ph.D., RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified EAET for Prediabetes; 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; Attempts to reduce stress and improve health behavior by engaging in emotional awareness and expression leading to changes in interpersonal relationships and health behavior

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Stress reduction; Emotional Awareness and Expression Therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: IRB-19-09-1275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No