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Behavioural Intervention

Self-Affirmation for Type 2 Diabetes

N/A

Waitlist Available

Research Sponsored by Elizabeth Scharnetzki

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after each intervention; completed 4 times over the course of a year

Awards & highlights

Study Summary

This trial aims to help individuals with diabetes cope with the negative effects of stigma by having them complete self-affirmation exercises before their doctor appointments. The researchers want to know if self-affirmation can

Who is the study for?

This trial is for adults with type 2 diabetes who are already using a continuous glucose monitor. It's designed to see if self-affirmation exercises before doctor visits can help manage the emotional and psychological challenges of living with diabetes.Check my eligibility

What is being tested?

Participants will do writing exercises that focus on their self-worth before their regular wellness appointments over a year. The study aims to find out if these exercises reduce stigma, boost motivation for managing diabetes, and improve blood sugar control compared to those on a waitlist.See study design

What are the potential side effects?

Since this intervention involves non-medical writing exercises, there are no direct physical side effects expected. However, participants may experience varying emotional responses due to reflecting on personal experiences during the exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after each intervention; completed 4 times over the course of a year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after each intervention; completed 4 times over the course of a year

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after each intervention; completed 4 times over the course of a year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood glucose

Confidence in Diabetes Self-Care Scale

Diabetes Stigma Assessment Scale

+3 more

Secondary outcome measures

Continuous glucose monitor use

Diabetes Management Plan

Generalized Anxiety Disorder 7-item (moderator/covariate)

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Self-AffirmationExperimental Treatment1 Intervention

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.

Group II: Waitlist ControlPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Elizabeth ScharnetzkiLead Sponsor

MaineHealth Institute for ResearchUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial currently accepting new participants?

"As per clinicaltrials.gov, the aforementioned study is not presently open for recruitment. Its initial posting was on April 1st, 2024, with the most recent update being on March 28th of the same year. Despite this trial no longer accepting participants, there are currently 1395 other trials actively seeking eligible candidates."

Answered by AI

What are the projected results that researchers hope to achieve with this investigation?

"The primary aim of this clinical investigation, to be assessed immediately post each intervention occurrence and repeated four times within a year, is to evaluate the Confidence in Diabetes Self-Care Scale. Secondary targets encompass Weight - collected as part of an EPIC data requisition for BMI computation; Patient Race - self-reported racial identification from options including White, Black, Asian, Native American or Alaska Native, Middle Eastern or North African, Native Hawaiian or other Pacific Islander with provision for specifying another identity or opting not to disclose; and Patient's highest educational attainment reflected by various selections ranging from 8th grade completion through advanced degrees like Master's or doctorate"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Strategies to Improve Well-Being and Diabetes Management

Elizabeth Scharnetzki 2024. "Strategies to Improve Well-Being and Diabetes Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06348238.