Emotional Awareness and Expression Therapy for Prediabetes

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05344196
• Other study ID #: IRB-19-09-1275
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2023
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Hemoglobin A1c from venous blood	Change from baseline to 3-month follow-up and 6-month follow-up
Primary	C-peptide	venous blood surrogate marker of insulin levels	Change from baseline to 3-month follow-up and 6-month follow-up
Secondary	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
Secondary	Body mass index	Measure of overweight / obesity	Change from baseline to 3-month follow-up and 6-month follow-up
Secondary	Health behavior	Self-reported exercise and diet over the past week	Change from baseline to 3-month follow-up and 6-month follow-up