Emotional Awareness and Expression Therapy for Prediabetes

NCT05344196 | Completed

• 1 other identifier: IRB-19-09-1275
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PreDiabetes

Keywords

Stress reduction; Emotional Awareness and Expression Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Perceived Stress Scale

  Change from baseline to 3-month follow-up and 6-month follow-up

• Body mass index

  Change from baseline to 3-month follow-up and 6-month follow-up

• Health behavior

  Change from baseline to 3-month follow-up and 6-month follow-up

Study Arms (1)

Modified EAET for Prediabetes

EXPERIMENTAL

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

Interventions

Modified EAET for prediabetes BEHAVIORAL

Attempts to reduce stress and improve health behavior by engaging in emotional awareness and expression leading to changes in interpersonal relationships and health behavior

Modified EAET for Prediabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 25, 2022
• Study Start: March 1, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)