Recruiting

Dyadic Intervention

Sponsor:

Massachusetts General Hospital

Code:

NCT07018726

Conditions

Young Onset Dementia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Resilient Together-YOD

Health Enhancement Program-YOD

Study Details

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 ID

NCT07018726

Start date

Jan 28, 2026

Status verified date

Apr, 2026

Completion date

Jan 1, 2031

Anticipated

Primary completion date

Jul 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

388 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Experimental Patient-Caregiver Dyads

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

active comparator: Control Patient-Caregiver Dyads

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

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.

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.

Primary outcome measure

  • Change in Emotional Distress [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]

Central Contacts and Locations

Central contacts

Ana-Maria Vranceanu, PhD

617-724-4977avranceanu@mgh.harvard.edu

Maggie L Syme, PhD, MPH

msyme@mgh.harvard.edu

Locations

Massachusetts General Hospital (MGH)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ana-Maria Vranceanu, PhD

617-724-4977avranceanu@mgh.harvard.edu

Principal Investigator:

Ana-Maria Vranceanu, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Emotional Distress
  • Dyadic Intervention
  • Young Onset Dementia
  • Caregiving

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-15.