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

NCT07018726 | Recruiting DMC

• 1 other identifier: 2025P001534
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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

Keywords

Emotional Distress; Dyadic Intervention; Young Onset Dementia; Caregiving

Outcome Measures

Primary Outcomes (1)

• Change in Emotional Distress

  Hospital Depression and Anxiety Scale total score (HADS); 0-21 for each subscale (anxiety and depression), higher scores indicate greater anxiety or depression

  0 weeks, 6 weeks, 12 weeks

Secondary Outcomes (6)

• Change in Resiliency Factors (Mindfulness)

  0 weeks, 6 weeks, 12 weeks

• Change in Resiliency Factors (Individual Coping)

  0 week, 6 weeks, 12 weeks

• Change in Resiliency Factors (Mindfulness Utilization)

  0 weeks, 6 weeks, 12 weeks

• Changes in Interpersonal Factors (Dyad Coping)

  0 weeks, 6 weeks, 12 weeks

• Changes in Resiliency Factors (Perceived Social Support)

  0 weeks, 6 weeks, 12 weeks

Other Outcomes (2)

• Global Impressions of Change

  6 weeks, 12 weeks

• Cognition

  0 weeks

Study Arms (2)

Experimental: Experimental Patient-Caregiver Dyads

EXPERIMENTAL

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

Behavioral: Resilient Together-YOD

Control Patient-Caregiver Dyads

ACTIVE COMPARATOR

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

Behavioral: Health Enhancement Program-YOD

Interventions

Resilient Together-YOD 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.

Also known as: Skills-based intervention

Experimental: Experimental Patient-Caregiver Dyads

Health Enhancement Program-YOD 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.

Also known as: Educational program

Control Patient-Caregiver Dyads

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

RECRUITING

Central Study Contacts

Ana-Maria Vranceanu, PhD

CONTACT

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

Maggie L Syme, PhD, MPH

CONTACT

msyme@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor/Director

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)