DementiaNCT06473571
Effects on Dementia Caregivers
A study testing Intervention Protocol (The 3GT) in people with Dementia, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Intervention Protocol (The 3GT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 4 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: Testing a Strategy to Improve the Effects of Caregiving for Caregivers of Persons with Dementia
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Intervention Protocol (The 3GT), Control Group
- Keywords
- dementia, caregivers
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control GroupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start14 Mar 2023
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole McClure, MS, MA, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473571
- Sponsor's protocol ID
- STUDY00004299
- Status last verified
- Dec 2024
- First submitted
- 19 Jun 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Strategy to Improve the Effects of Caregiving for Caregivers of Persons with Dementia
- ClinicalTrials.gov ID
- NCT06473571
- Acronym / sponsor ID
- STUDY00004299
- Conditions
- Dementia
- Keywords
- dementia, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Protocol (The 3GT) | Active comparator | Other: 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. |
| Control Group | Active comparator | Other: Control GroupParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention Protocol (The 3GT) |
| Control GroupParticipants 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 |
Primary outcome
To measure gratitude using The Gratitude Questionnaire (GQ-6)
Time frame: 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 depressive symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D 10)
Time frame: 6 months
For this study, the 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10) will be used to measure depressive symptoms
To measure burnout using The Informal Caregiver Burnout Inventory 10 (ICBI-10)
Time frame: 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)
Time frame: 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 measure positive reframing using the Brief COPE Inventory: Positive Reinterpretation subscale
Time frame: 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 evaluate practical implications of positive reframing using the Positive Aspects of Caregiving measure
Time frame: 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").
Assess caregiver burden using the Zarit Burden Interview
Time frame: 6 months
The Zarit Burden Interview, short form (ZBI-SF) will be used to measure participants subjective burden related to their caregiving role.
To asses ICN1-10 validity, the Burnout Measure, Short (BMS) will be used
Time frame: 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 daily depressive symptoms using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 6 months
4 questions adapted from the The NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form depression item will be used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole McClure, MS, MA principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Protocol (The 3GT) in people with Dementia, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure gratitude using The Gratitude Questionnaire (GQ-6) (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.