跳至主要内容
临床试验/NCT06473571
NCT06473571已完成不适用

Testing a Strategy to Improve the Effects of Caregiving for Caregivers of Persons with Dementia

University of Central Florida2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
To evaluate practical implications of positive reframing using the Positive Aspects of Caregiving measure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

To evaluate practical implications of positive reframing using the Positive Aspects of Caregiving measure

时间窗: 6 months

The Positive Aspects of Caregiving measure is a 9-item self-report scale assessing the positive factors associated with caregiving, utilizing a 5-point Likert scale ranging from 1 ("Disagree a lot") to 5 ("Agree").

To measure positive reframing using the Brief COPE Inventory: Positive Reinterpretation subscale

时间窗: 6 months

To measure positive reframing, the Brief COPE Inventory: Positive Reinterpretation subscale will be used (Items 12 and 17), which is a measure that assess different types of coping utilized by individuals in stressful situations.

To measure gratitude using The Gratitude Questionnaire (GQ-6)

时间窗: 6 months

The Gratitude Questionnaire (GQ-6), which is a widely used measure trait gratitude will be used. The GQ-6 is a 6 item self-report questionnaire that assesses gratitude disposition in an individual.

To measure burnout using The Informal Caregiver Burnout Inventory 10 (ICBI-10)

时间窗: 6 months

The Informal Caregiver Burnout Inventory 10 (ICBI-10) is a new measure developed to capture burnout specifically in caregivers, aiming to validate prior attempts to modify language in general use burnout measures that typically capture occupational burnout.

To assess positive emotion using The Positive and Negative Affect Schedule (PANAS)

时间窗: 6 months

The Positive and Negative Affect Schedule (PANAS) will be utilized to assess positive affect. The PANAS is a 20-item self-report measure assessing two dimensions of affect (positive and negative) utilizing 5-point Likert scale.

To asses ICN1-10 validity, the Burnout Measure, Short (BMS) will be used

时间窗: 6 months

To provide convergent validity for the use of the ICBI-10 in this sample, the Burnout Measure, Short (BMS) will be used, which is a widely used measure of burnout. The BMS is a 10-item, self-report measure that assess three factors of burnout including physical, emotional and mental exhaustion.

To measure depressive symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D 10)

时间窗: 6 months

For this study, the 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10) will be used to measure depressive symptoms

Assess caregiver burden using the Zarit Burden Interview

时间窗: 6 months

The Zarit Burden Interview, short form (ZBI-SF) will be used to measure participants subjective burden related to their caregiving role.

To measure daily depressive symptoms using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)

时间窗: 6 months

4 questions adapted from the The NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form depression item will be used.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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