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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist caregivers of relatives with Alzheimer's or related dementia (ADRD) by providing support through counseling and social media chat groups. It focuses on Chinese and Korean American caregivers in New York City and Bergen County, New Jersey. The study will test whether these interventions, known as the NYU Caregiver Intervention-Enhanced Support (NYUCI-ES), reduce stress, depression, and health risks associated with heart disease and other metabolic conditions. Eligible participants are primary family caregivers with conditions like high blood pressure or diabetes who assist relatives with memory issues. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance caregiver support and well-being.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the New York University Caregiver Intervention (NYUCI) is safe for individuals. Studies have found that this program not only reduces stress and burden for dementia caregivers but also improves their mental and physical health. This is crucial because stress can harm the body and mind over time. The NYUCI has been successfully applied to various groups, including Asian-American caregivers, demonstrating its effectiveness across different cultures.

Reports do not mention any serious negative effects from the NYUCI. Instead, caregivers report greater satisfaction with social support and experience less family conflict. These positive outcomes suggest that the program is both safe and beneficial for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a comprehensive approach to supporting dementia caregivers, which is different from the usual support options like basic counseling or informational sessions. This treatment uniquely combines structured counseling sessions, local support group participation, and flexible "ad hoc" counseling to address the emotional and practical challenges caregivers face. By integrating various support methods, this approach aims to provide more personalized and immediate relief, potentially improving the overall well-being of caregivers more effectively than existing options.

What evidence suggests that the NYUCI-ES intervention could be effective for dementia caregivers?

In this trial, participants in the Treatment Group will receive the NYU Caregiver Intervention with Enhanced Support (NYUCI-ES). Research shows that this intervention reduces stress and improves well-being for those caring for someone with dementia. In past studies, caregivers in this program felt less depressed and stressed. The program also reduces the likelihood of caregivers needing to move their loved ones into nursing homes. This means the program not only supports caregivers' mental health but also enhances their caregiving skills. For Asian American caregivers, adjusting the program to fit cultural needs may increase its effectiveness. Meanwhile, participants in the Control Group will join an online chat group and have access to a counselor for resource information and support as needed. ^{1 2 6 7 8}

Who Is on the Research Team?

Bei Wu, PhD

Principal Investigator

New York University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/search/iReWOc7ZIUSH2_wPfYegpw/project-details/10915552

NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes ... The NYUCI has proven efficacy in reducing psychological outcomes among largely White samples of caregivers of persons with ADRD and has been widely replicated ...

2. shanghai.nyu.edu shanghai.nyu.edu/news/stigma-support-research-engaging-asian-american-dementia-caregivers

From Stigma to Support: Research on Engaging Asian ... The study comes out of an initiative Wu and her team launched in 2021, the New York University Caregiver Intervention plus Enhanced Support ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3826164/

Effects of the NYU Caregiver Intervention-Adult Child on ... Results: Two thirds (66%) of adult child caregivers in the control condition admitted their parent to a residential care setting compared with 37% in the ...

4. apa.org apa.org/pi/about/publications/caregivers/practice-settings/intervention/nyu-intervention

New York University Caregiver Intervention (NYUCI) This intervention tool reduces burden and distress in dementia caregivers and improves quality of care for care recipients.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01306695

Northern Manhattan Caregiver Intervention Project (NOCIP) The goal of this study is to compare the effectiveness of an existing evidence-based dementia family caregiver intervention, the New York University Caregiver ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5946885/

Process Evaluation of the NYU Caregiver Intervention- ... The purpose of this study was to conduct a process evaluation of the New York University Caregiver Intervention-Adult Child (NYUCI-AC) to describe its delivery.

7. ncoa.org ncoa.org/article/evidence-based-program-new-york-university-caregiver-intervention-nyuci/

New York University Caregiver Intervention (NYUCI) Health outcomes: Studies show the intervention benefits the caregiver's mental and physical health and delays institutional placement of the ...

8. withpower.com withpower.com/trial/phase-heart-diseases-9-2022-2da51

Psychosocial Intervention for Dementia Caregivers The NYU Caregiver Intervention (NYUCI) significantly improved caregiver satisfaction with social support and reduced family conflict over time, based on data ...