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Completed

NCT Number: NCT05344196

Emotional Awareness and Expression Therapy for Prediabetes

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. HbA1c

    Time frame: Change from baseline to 3-month follow-up and 6-month follow-up

    Hemoglobin A1c from venous blood

  2. C-peptide

    Time frame: Change from baseline to 3-month follow-up and 6-month follow-up

    venous blood surrogate marker of insulin levels

Secondary outcomes

  1. Perceived Stress Scale

    Time frame: Change from baseline to 3-month follow-up and 6-month follow-up

    Psychological stress (scores from 0 to 40; higher scores indicate more perceived stress)

  2. Body mass index

    Time frame: Change from baseline to 3-month follow-up and 6-month follow-up

    Measure of overweight / obesity

  3. Health behavior

    Time frame: Change from baseline to 3-month follow-up and 6-month follow-up

    Self-reported exercise and diet over the past week

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2022
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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