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Effects on Dementia Caregivers

NCT ID: NCT06473571

Last Updated: 2024-12-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2024-01-04

Brief Summary

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The Three Good Things (3GT) is a gratitude list intervention that is empirically supported (Emmons \& McCullough, 2003; Seligman et al., 2005) and is a low-cost, easily accessible tool for medical and mental providers to recommend and dementia caregivers to implement independently. Thus, this study aims to investigate the feasibility of use of 3GT in the dementia caregiving population and investigate potential therapeutic mechanisms of the intervention.

Detailed Description

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The hypothesis predicts that Caregivers of persons diagnosed with dementia who are randomized into the intervention group (3GT) will report reduced levels of depression, burden, burnout, show an increase in levels of gratitude, increased positive emotion, and increased positive reframing (Brief COPE: Positive Reinterpretation scale and Positive Aspects of Caregiving measure) as compared to baseline levels, and post-follow up assessment in 15 days. The participants will be recruited from local community partners and Amazon MTurk. They will be randomized into 2 groups; one group will be asked to reflect on three good things that happened that day, and the other group will be asked to reflect on early memories. Participants will be reminded via text message daily for 15 days and asked to document their three good things or early memories on a Qualtrics link that will be provided in the text message. Additionally, they will be asked to answer 10 mood-related questions daily. An ANOVA will be used to assess the pre and post intervention differences between groups for depression, burden, burnout, gratitude, positive emotion, and positive reframing. Multilevel modeling will be used to assess the relationships between gratitude and depression at the within-subjects level and then between-subjects by intervention condition. Identified demographic factors will be added to covary at both levels of analysis. Data will be de-identified and stored on a University of Central Florida local hard drive, which requires special permission and password-protected profiles.

Conditions

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Dementia

Keywords

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dementia caregivers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Protocol (The 3GT)

Participants will be asked to identify three things that went well that day and their role for this occurring \["What went well today, and what was your role in making it happen?" as adapted from (Sexton \& Adair, 2019)\]. They will be asked to engage in this exercise for 15 days during the evening.

Group Type ACTIVE_COMPARATOR

Intervention Protocol (The 3GT)

Intervention Type OTHER

Participants will be asked to identify three things that went well that day and their role for this occurring \["What went well today, and what was your role in making it happen?" as adapted from (Sexton \& Adair, 2019)\]. They will be asked to engage in this exercise for 15 days during the evening.

Control Group

Participants will be asked to reflect on early memories of their life, with no specific prompts provided, for 15 days during the evening. This activity is consistent with prior efficacy studies of 3GT (Seligman et al., 2005).

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

Participants will be asked to reflect on early memories of their life, with no specific prompts provided, for 15 days during the evening. This activity is consistent with prior efficacy studies of 3GT (Seligman et al., 2005).

Interventions

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Intervention Protocol (The 3GT)

Participants will be asked to identify three things that went well that day and their role for this occurring \["What went well today, and what was your role in making it happen?" as adapted from (Sexton \& Adair, 2019)\]. They will be asked to engage in this exercise for 15 days during the evening.

Intervention Type OTHER

Control Group

Participants will be asked to reflect on early memories of their life, with no specific prompts provided, for 15 days during the evening. This activity is consistent with prior efficacy studies of 3GT (Seligman et al., 2005).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Self-identified caregivers of persons with dementia at least 18 years of age
* Identify English as their primary language
* Self-report current care for an older adult with dementia identified by a medical professional

Exclusion Criteria

* Participants that are currently receiving psychotherapy, have a diagnosis of dementia, and/or severe mental illness
* Individuals under the age of 18 years old
* Adults who cannot consent in English
* Pregnant women and prisoners will not be included in the study.
* Participants who do not have access to a phone that can not receive text messages will not be able to participate, as equipment will not be provided to Participants.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole McClure, MS, MA

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

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University of Central Florida

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004299

Identifier Type: -

Identifier Source: org_study_id