Strategies to Improve Well-Being and Diabetes Management
NCT ID: NCT06348238
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-07-24
2027-02-28
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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MaineHealth
OTHER
Elizabeth Scharnetzki
OTHER
Responsible Party
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Elizabeth Scharnetzki
Faculty Scientist I
Principal Investigators
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Elizabeth Scharnetzki
Role: PRINCIPAL_INVESTIGATOR
MaineHealth
Locations
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MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research
Westbrook, Maine, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2074997
Identifier Type: -
Identifier Source: org_study_id
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