Psychosocial Intervention for Dementia Caregivers

Overseen By Agnes Leong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Alcohol, Substance abuse, Psychiatric history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk \[population social media app for Chinese/Korean\] peer support which we call the NYUCI-ES in reducing health risks for cardiometabolic disease among older Chinese and Korean American adults caring for relatives with ADRD. In collaboration with community organizations across the New York and northern New Jersey metropolitan area, we will enroll 300 caregivers of people with ADRD (150 Chinese and 150 Korean) in this study. Aim 1: Develop culturally adapted informational and educational materials about dementia and caregiving issues for social service providers of the intervention and for family caregivers. Aim 2: Test the hypothesis, H1: A counseling and support intervention (the NYUCI-ES) will significantly improve psychosocial factors such as depression, stress self-rated health and chronic disease management among Chinese and Korean-American ADRD caregivers and these changes will be mediated by improvement in social support. H1a: By the first (6- month) follow-up, the mediators (increases in social support, stress reaction) will improve significantly in the intervention group compared to baseline values and the control group. H1b: These improvements will be maintained, and lead to reduction in depressive symptoms, and improvement in self-reported health and chronic disease self-management by the 12-month follow-up compared to the control group. Aim 3: Test the hypothesis, H2: the NYUCI-ES will reduce biologic risk factors, including metabolic health (glycosylated hemoglobin) and inflammation (Oxidative stress, lipid metabolism, etc.) within 6 months of enrollment compared to baseline and a control group; these changes will be mediated through increases in social support and decreases in depressive symptoms and will be maintained at the 12-month follow-up. The public health significance of these findings will likely have an impact on health care policy for CGs from diverse underserved ethnic and cultural backgrounds, potentially reducing morbidity, and improving their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing support and education rather than changing medication regimens.

What data supports the effectiveness of the treatment NYU Caregiver Intervention-Enhanced Support for dementia caregivers?

Research shows that the NYU Caregiver Intervention helps dementia caregivers by increasing their satisfaction with social support and reducing family conflict. It also suggests potential improvements in quality of life and a decrease in caregiver burden. ^{1 2 3 4 5}

Is the NYU Caregiver Intervention safe for humans?

The NYU Caregiver Intervention has been widely used in various countries and studies, and there are no reports of safety concerns or harmful effects for participants. ^{1 3 4 5 6}

How is the NYU Caregiver Intervention-Enhanced Support treatment different from other treatments for dementia caregivers?

The NYU Caregiver Intervention-Enhanced Support is unique because it is a psychosocial treatment specifically designed to support caregivers of people with dementia, focusing on reducing caregiver stress and improving their well-being. Unlike other treatments, it has been adapted for different cultural contexts and has shown benefits in delaying the need for residential care placement for the person with dementia. ^{2 3 4 5 7}

Research Team

Bei Wu, PhD

Principal Investigator

New York University

Eligibility Criteria

This trial is for older Chinese and Korean American adults (50+) in New York or Bergen County, NJ who are primary caregivers for relatives with dementia. They must have internet access, read English/Chinese/Korean, and meet certain health criteria like diabetes or high cholesterol but not be dealing with substance abuse or recent psychiatric hospitalizations.

Inclusion Criteria

Have access to Internet and phone with SMS and voice messaging

You do not plan to move to a different place for the next 12 months.

I have or might have diabetes, high cholesterol, high blood pressure, or am overweight.

Exclusion Criteria

I have been hospitalized for a psychiatric condition in the last 5 years.

You are currently abusing alcohol or drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NYUCI-ES intervention, including 6 counseling sessions, participation in local support groups, and online chat groups

6 months

6 counseling sessions, ongoing online support

Follow-up

Participants are monitored for psychosocial and biological health outcomes, including hypertension, depressive symptoms, and chronic disease management

12 months

Treatment Details

Interventions

• Treatment Group

Trial Overview The study tests a culturally tailored support program (NYUCI-ES) that includes counseling and online peer groups via WeChat/Kakaotalk to improve mental health and manage chronic diseases in caregivers. The goal is to see if this intervention reduces stress, depression, improves social support, self-rated health, and lowers risk factors for heart disease within 6 months.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Treatment group will receive 6 counseling sessions, participate in local support group and on-line chat group, and receive "ad hoc' counseling.

Group II: Control Group Active Control 1 Intervention

Control group will participate in on-line chat group, and call the counselor for resource information and support as needed.

Treatment Group is already approved in United States for the following indications:

Approved in United States as NYUCI-ES for:

• Psychosocial support for ADRD caregivers

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Findings from Research

The NYU Caregiver Intervention (NYUCI) significantly improved caregiver satisfaction with social support and reduced family conflict over time, based on data from 294 participants across three states (Georgia, Utah, Wisconsin).

While caregivers reported increased quality of life and decreased burden, depressive symptoms remained stable, indicating that while the intervention was effective in some areas, it may not address all aspects of caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Validity of the New York University Caregiver Intervention: Key Caregiver Outcomes Across Multiple Demonstration Projects. Fauth, EB., Jackson, MA., Walberg, DK., et al.[2020]

The NYU Caregiver Intervention for Adult Children (NYUCI-AC) significantly reduced depressive symptoms and improved quality of life for 107 adult child caregivers of persons with dementia over a period of up to 3.79 years, as shown by statistically significant decreases in withdrawal and apathy.

Caregivers receiving the NYUCI-AC treatment experienced ongoing support through individual and family counseling, which helped them enhance their overall quality of life compared to those in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Minnesota Adaptation of the NYU Caregiver Intervention on Depressive Symptoms and Quality of Life for Adult Child Caregivers of Persons with Dementia. Gaugler, JE., Reese, M., Mittelman, MS.[2022]

The New York University Caregiver Intervention-Adult Child (NYUCI-AC) program significantly helped adult child caregivers manage care-related stress, with participants completing an average of 5.19 counseling sessions over about 11 months.

Individual counseling sessions were particularly effective in reducing caregivers' subjective stress, especially during the first year, highlighting the importance of personalized support in caregiver interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process Evaluation of the NYU Caregiver Intervention-Adult Child. Gaugler, JE., Reese, M., Mittelman, MS.[2022]

In a study involving 107 adult child caregivers of individuals with dementia, the NYU Caregiver Intervention adapted for adult children (NYUCI-AC) significantly reduced the likelihood of residential care placement, with only 37% of participants in the treatment group admitting their parents compared to 66% in the control group.

Participants in the NYUCI-AC group not only had a lower admission rate but also delayed the time to admission by an average of 228.36 days, highlighting the intervention's effectiveness in providing the necessary support for caregivers to manage care at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the NYU caregiver intervention-adult child on residential care placement. Gaugler, JE., Reese, M., Mittelman, MS.[2022]

The NYU Caregiver Intervention (NYUCI) significantly reduced depressive symptoms in spouse caregivers of Alzheimer's patients, as shown in a study with 100 participants over two years, indicating its efficacy in a non-English speaking context.

The successful adaptation of the NYUCI in Israel has led to its implementation in 30 municipalities, highlighting its potential for broader application in supporting caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing an evidence-based intervention for spouse caregivers of persons with Alzheimer's disease: results of a community implementation of the NYUCI in Israel. Werner, P., Clay, OJ., Goldstein, D., et al.[2021]

This study is the first randomized controlled trial testing the effectiveness of the New York University Caregiver Intervention (NYUCI) specifically in Hispanic caregivers of persons with dementia, including a broader range of relatives beyond just spouses.

The intervention, which lasts for 6 months, aims to reduce depression and caregiver burden, with outcomes measured using the Geriatric Depression Scale and the Zarit Caregiver Burden Scale, highlighting its potential to address significant psychosocial stressors in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Northern Manhattan Caregiver Intervention Project: a randomised trial testing the effectiveness of a dementia caregiver intervention in Hispanics in New York City. Luchsinger, J., Mittelman, M., Mejia, M., et al.[2021]

Family carers of individuals with dementia reported positive experiences from a multicomponent psychosocial intervention program, highlighting the importance of content and social support in their participation.

Carers suggested that future interventions should include more extensive content and improved group organization, emphasizing the need for earlier and more flexible support for both carers and individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family carers' experiences of attending a multicomponent psychosocial intervention program for carers and persons with dementia. Johannessen, A., Bruvik, FK., Hauge, S.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

External Validity of the New York University Caregiver Intervention: Key Caregiver Outcomes Across Multiple Demonstration Projects. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Effects of the Minnesota Adaptation of the NYU Caregiver Intervention on Depressive Symptoms and Quality of Life for Adult Child Caregivers of Persons with Dementia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Process Evaluation of the NYU Caregiver Intervention-Adult Child. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of the NYU caregiver intervention-adult child on residential care placement. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Assessing an evidence-based intervention for spouse caregivers of persons with Alzheimer's disease: results of a community implementation of the NYUCI in Israel. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The Northern Manhattan Caregiver Intervention Project: a randomised trial testing the effectiveness of a dementia caregiver intervention in Hispanics in New York City. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Family carers' experiences of attending a multicomponent psychosocial intervention program for carers and persons with dementia. [2020]