Effects on Dementia Caregivers

NCT06473571 | Completed

• 1 other identifier: STUDY00004299
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

dementia; caregivers

Outcome Measures

Primary Outcomes (9)

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

  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.

  6 months

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

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

  6 months

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

  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.

  6 months

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

  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.

  6 months

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

  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.

  6 months

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

  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").

  6 months

• Assess caregiver burden using the Zarit Burden Interview

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

  6 months

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

  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.

  6 months

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

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

  6 months

Study Arms (2)

Intervention Protocol (The 3GT)

ACTIVE COMPARATOR

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.

Other: Intervention Protocol (The 3GT)

Control Group

ACTIVE COMPARATOR

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).

Other: Control Group

Interventions

Intervention Protocol (The 3GT) 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.

Intervention Protocol (The 3GT)

Control Group 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).

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Dementia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nicole McClure, MS, MA

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: March 14, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)