Strategies to Improve Well-Being and Diabetes Management

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must be at least 18 years of age, have a type 2 diabetes (T2D) diagnosis, and currently use a continue glucose monitor as part of their condition management.

• Participants must be patients of MaineHealth Endocrinology and Diabetes, be at least 18 years of age, have a type 2 diabetes (T2D) diagnosis, and currently use a continue glucose monitor as part of their condition management (Dexcom, FreeStyle Libre).

Locations
United States
Maine
MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research
RECRUITING
Westbrook
Contact Information
Primary
Elizabeth Scharnetzki
elizabeth.scharnetzki@mainehealth.org
8053409716
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 150
Treatments
Experimental: Self-Affirmation
Participants review a list of values and are instructed to choose up to two that are important to them. The values listed are intentionally unrelated to the threat-inducing domain so that the exercise broadens participants' focus. Next, participants are 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.
Sham_comparator: Waitlist Control
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.
Related Therapeutic Areas
Sponsors
Collaborators: MaineHealth
Leads: Elizabeth Scharnetzki

This content was sourced from clinicaltrials.gov