Strategies to Improve Well-Being and Diabetes Management

NCT06348238 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Self-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.

Sponsors & Collaborators

  • MaineHealth

    collaborator OTHER
  • Elizabeth Scharnetzki

    lead OTHER

Principal Investigators

  • Elizabeth Scharnetzki · MaineHealth

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-24
Primary Completion
2026-03-28
Completion
2027-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06348238 on ClinicalTrials.gov