Clinical trial NCT05344196: Emotional Awareness and Expression Therapy for Prediabetes
Official title: Examining the Effect of a Novel Stress Reduction Intervention no the Control of Prediabetes: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: Stress reduction
Emotional Awareness and Expression Therapy
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: HbA1c
timeFrame: Change from baseline to 3-month follow-up and 6-month follow-up
measure: C-peptide
timeFrame: Change from baseline to 3-month follow-up and 6-month follow-up
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Change from baseline to 3-month follow-up and 6-month follow-up
measure: Body mass index
timeFrame: Change from baseline to 3-month follow-up and 6-month follow-up
measure: Health behavior
timeFrame: Change from baseline to 3-month follow-up and 6-month follow-up
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References: