Examining the Effect of a Novel Stress Reduction Intervention no the Control of Prediabetes: A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PreDiabetes
- Sponsor
- Wayne State University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- C-peptide
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Mark A. Lumley
Professor
Wayne State University
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
- •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)
Outcomes
Primary Outcomes
C-peptide
Time Frame: Change from baseline to 3-month follow-up and 6-month follow-up
venous blood surrogate marker of insulin levels
HbA1c
Time Frame: Change from baseline to 3-month follow-up and 6-month follow-up
Hemoglobin A1c from venous blood
Secondary Outcomes
- 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)