Clinical trial NCT06473571: Effects on Dementia Caregivers
Official title: Testing a Strategy to Improve the Effects of Caregiving for Caregivers of Persons with Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
caregivers
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To measure gratitude using The Gratitude Questionnaire (GQ-6)
timeFrame: 6 months
measure: To measure depressive symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D 10)
timeFrame: 6 months
measure: To measure burnout using The Informal Caregiver Burnout Inventory 10 (ICBI-10)
timeFrame: 6 months
measure: To assess positive emotion using The Positive and Negative Affect Schedule (PANAS)
timeFrame: 6 months
measure: To measure positive reframing using the Brief COPE Inventory: Positive Reinterpretation subscale
timeFrame: 6 months
measure: To evaluate practical implications of positive reframing using the Positive Aspects of Caregiving measure
timeFrame: 6 months
measure: Assess caregiver burden using the Zarit Burden Interview
timeFrame: 6 months
measure: To asses ICN1-10 validity, the Burnout Measure, Short (BMS) will be used
timeFrame: 6 months
measure: To measure daily depressive symptoms using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Nicole McClure, MS, MA
role: PRINCIPAL_INVESTIGATOR
References: