Resilient Together for Early Onset Dementia

Overseen By Maggie L Syme, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Terminal illness, Severe mental health, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help individuals with young onset dementia (YOD) and their care partners manage emotional distress together. The goal is to determine if a virtual, six-session intervention, called the Resilient Together-YOD program, can improve resilience and well-being in both the person with YOD and their care partner. Participants will be divided into two groups: one focusing on skill-building and the other on educational content, all delivered via Zoom. Ideal participants are those diagnosed with YOD in the last six months, who have a care partner interested in joining the sessions, and who experience emotional distress. As an unphased trial, this study offers a unique opportunity to contribute to innovative research aimed at enhancing emotional resilience and well-being.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on emotional support, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What prior data suggests that this intervention is safe for patient-caregiver dyads?

Research has shown that the Resilient Together-YOD program is expected to have mild side effects for people with Young Onset Dementia (YOD). Participants in similar programs have not reported major negative effects, indicating general safety. Studies have not identified any serious adverse reactions linked to this type of program.

Specific studies on the safety of the Health Enhancement Program-YOD are not yet available. However, as the trial is just beginning and the program uses video sessions to teach skills, it is likely safe. These programs typically focus on emotional and mental health support, which generally carry low risk.

Overall, both programs aim to help without causing harm, offering promising options for people living with YOD and their caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Resilient Together for Early Onset Dementia" trial because it explores new ways to support both patients and caregivers through live video sessions. Unlike traditional treatments, which often focus solely on medication or cognitive exercises, this trial emphasizes skill-building and education delivered via Zoom. This approach could provide more accessible and personalized support, helping to improve the quality of life for those affected by early onset dementia.

What evidence suggests that this trial's treatments could be effective for preventing chronic emotional distress in young onset dementia dyads?

Research has shown that involving both the patient and caregiver in treatment, known as dyadic interventions, effectively supports families dealing with chronic conditions like Young Onset Dementia (YOD). In this trial, participants in the "Experimental Patient-Caregiver Dyads" arm will engage in the Resilient Together-YOD program, which has shown promise in boosting resilience and reducing emotional stress for both patients and caregivers. Designed for ease of participation and positive reception, it aims to improve overall well-being and quality of life. Meanwhile, participants in the "Control Patient-Caregiver Dyads" arm will take part in the Health Enhancement Program-YOD, which provides caregivers with essential information to better handle the challenges of YOD. These programs aim to offer practical support and improve the emotional health of both patients and caregivers. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pairs where one person has Young Onset Dementia (YOD) and the other is their care-partner. They must be willing to participate together in a virtual program designed to prevent long-term emotional distress.

Inclusion Criteria

Received YOD diagnosis in the past 6 months (patient)

I understand the study details and agree to participate.

I was diagnosed with dementia before turning 65.

Exclusion Criteria

Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use

Lack of access to internet and/or a device with a camera

I have been diagnosed with another terminal condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a virtual, brief (6 sessions) dyadic intervention to prevent chronic emotional distress

6 weeks

6 sessions (virtual)

Follow-up

Participants are monitored for changes in self-efficacy, relationship quality, emotional distress, and resiliency factors

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Enhancement Program-YOD
• Resilient Together-YOD

Trial Overview The study tests a short, online intervention called Resilient Together-YOD against another program named Health Enhancement Program-YOD. Both aim to improve resilience and quality of life over six sessions.

How Is the Trial Designed?

Group I: Experimental: Experimental Patient-Caregiver Dyads Experimental Treatment 1 Intervention

There will be 6 sessions delivered via live video using Zoom. Content will be primarily skills.

Group II: Control Patient-Caregiver Dyads Active Control 1 Intervention

There will be 6 sessions delivered via live video using Zoom. Content will be primarily educational.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11380298/

Navigating the Journey of Living with Young-Onset Dementia YOD significantly impacted family dynamics and led to changes in emotional communication within the family. The stigma surrounding YOD raised ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2214782922000379

A cross-sectional evaluation of the Dutch RHAPSODY ... The RHAPSODY program is tailored to the Dutch context, and is publicly available. The program met the informational needs of young-onset dementia caregivers.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/hsc.13383

Helpful post‐diagnostic services for young onset dementia ... Our study aim was to gather detailed information about services experienced as helpful by those with YOD and family carers.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837788

Race and Ethnicity and Comorbidities Among Medicare ... This cross-sectional study estimates the prevalence of young-onset dementia among Medicare beneficiaries aged 45 to 64 years from various ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8496799/

Prevalence and incidence of young onset dementia and ... The aim of this study is to provide YOD prevalence and incidence estimates in France and to study the contribution of comorbidities to YOD incidence.

6. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-07411-2

What do health professionals need to know about young onset ... Young onset dementia (YOD), in which dementia symptoms develop prior to 65 years of age, accounts for up to 8% of all dementia diagnoses [1].

7. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224011116

Feeling useful and engaged in daily life This study is the first to investigate the views of people with YOD and their caregivers on retaining a sense of usefulness in daily life. Results revealed four ...

8. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12695

Global incidence of young‐onset dementia: A systematic ... Reliable data on the incidence rates for young-onset dementia (YOD) are lacking, but are necessary for research on disease etiology and to ...