RecruitingNot ApplicableNCT06348238

Strategies to Improve Well-Being and Diabetes Management


Sponsor

Elizabeth Scharnetzki

Enrollment

150 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are: * Will self-affirmation reduce feelings of stigmatization? * Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors. * Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it. After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests strategies to improve mental well-being and diabetes self-management in adults with type 2 diabetes who use a continuous glucose monitor (a small device worn on the skin that tracks blood sugar in real time). The goal is to find out which approaches are most helpful for managing both diabetes and emotional health. **You may be eligible if...** - You are 18 or older - You have been diagnosed with type 2 diabetes - You currently use a continuous glucose monitor (such as a Dexcom or FreeStyle Libre) as part of your diabetes care - You are a patient at MaineHealth Endocrinology and Diabetes **You may NOT be eligible if...** - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSelf-Affirmation

Self-affirmation theory contends that integrity of one's self-concept (self integrity) is essential for navigating daily stressors. When individuals encounter information or contexts that pose a threat to one's self-integrity, we can adopt maladaptive coping strategies to alleviate the discomfort. One strategy for strengthening self-integrity is engage in an explicit process of reinforcing sources of self-worth - self-affirmation. Self affirmation interventions have participants engage in an exercise writing about core personal values (a writing induction). In a writing induction, participants review a list of values and are instructed to choose up to two that are important to them. Participants are then asked to write a few sentences about why their chosen values are important to them and identify times in which these values have helped them navigate challenges.


Locations(1)

MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research

Westbrook, Maine, United States

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NCT06348238


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