Emotional Awareness and Expression Therapy for Prediabetes

NCT ID: NCT05344196

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-15

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.

Conditions

PreDiabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Modified EAET for prediabetes

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Mark A. Lumley

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wayne State University

Detroit, Michigan, United States

Countries

United States

Other Identifiers

IRB-19-09-1275

Identifier Type: -

Identifier Source: org_study_id