Addressing Emotional Distress in Dyads of Persons With a Young Onset Dementia (YOD) and Their Care-partners

NCT ID: NCT07018726

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2031-01-01

Brief Summary

The purpose of the present investigation is to test the efficacy of a virtual, brief (6 sessions) dyadic (patient and care-partner together) intervention to prevent chronic emotional distress in dyads where one person is diagnosed with Young Onset Dementia (YOD). Through this study, we seek to address the unmet need of preventing chronic emotional distress in YOD dyads through a feasible, acceptable and credible program, and ideally enhance resiliency and improve wellbeing and quality of life in both members of the dyad.

Conditions

Young Onset Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Experimental Patient-Caregiver Dyads

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

Group Type: EXPERIMENTAL

Resilient Together-YOD

Intervention Type: BEHAVIORAL

This is a 6 session dyadic (patient and spousal care-partner) intervention that teaches resiliency and interpersonal communication skills early after YOD diagnoses. It aims to decrease heightened symptoms of depression and anxiety among dyads to help them engage in important decisions around long term care-planning and optimize adjustment. The goal is to equip dyads with the necessary skills to cope and engage in meaningful, challenging conversations around care-planning, symptom deterioration, work/family planning to improve well-being in both members of the dyad.

Control Patient-Caregiver Dyads

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

Group Type: ACTIVE_COMPARATOR

Health Enhancement Program-YOD

Intervention Type: BEHAVIORAL

This is a 6 session program that will deliver educational information to dyads and will mimic the dose and duration of Resilient Together. The program will not teach any individual and dyadic interpersonal skills, but will contain education on psychological distress and healthy behaviors. Sessions will also be delivered virtually.

Interventions

Resilient Together-YOD

This is a 6 session dyadic (patient and spousal care-partner) intervention that teaches resiliency and interpersonal communication skills early after YOD diagnoses. It aims to decrease heightened symptoms of depression and anxiety among dyads to help them engage in important decisions around long term care-planning and optimize adjustment. The goal is to equip dyads with the necessary skills to cope and engage in meaningful, challenging conversations around care-planning, symptom deterioration, work/family planning to improve well-being in both members of the dyad.

Intervention Type: BEHAVIORAL

Health Enhancement Program-YOD

This is a 6 session program that will deliver educational information to dyads and will mimic the dose and duration of Resilient Together. The program will not teach any individual and dyadic interpersonal skills, but will contain education on psychological distress and healthy behaviors. Sessions will also be delivered virtually.

Intervention Type: BEHAVIORAL

Other Intervention Names

Skills-based intervention; Educational program

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18-65 at the time of enrollment [both patient and care-partner]
• Diagnosis of young-onset dementia (FTD, PPA, AD, PCA, etc.) with symptom onset prior to age 65 [patient]
• A designated care-partner willing and interested to participate [both patient and care-partner]
• Received YOD diagnosis in the past 6 month [patient]
• English fluency and literacy [both patient and care-partner]
• Cognitive ability to understand study and research protocol in order to consent to study participation per referring neurologist [both patient and care-partner]
• Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores > 7)

Exclusion Criteria

• An additional, terminal diagnosis such as cancer
• Lack of access to internet and/or a device with a camera
• Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ana-Maria Vranceanu, PhD

Full Professor/Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ana-Maria Vranceanu, PhD

Role: CONTACT

avranceanu@mgh.harvard.edu

617-724-4977

Maggie L Syme, PhD, MPH

Role: CONTACT

msyme@mgh.harvard.edu

Facility Contacts

Ana-Maria Vranceanu, PhD

Role: primary

avranceanu@mgh.harvard.edu

617-724-4977

Other Identifiers

2025P001534

Identifier Type: -

Identifier Source: org_study_id