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

Mass General Brigham

Status: Enrolling

Conditions: Young Onset Dementia

Treatments: Behavioral: Health Enhancement Program-YOD; Behavioral: Resilient Together-YOD

Study type: Interventional

Funder types: Other

Identifiers

NCT07018726

2025P001534

Details and patient eligibility

About

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.

Enrollment: 388 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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388 participants in 2 patient groups

Experimental: Experimental Patient-Caregiver Dyads

Experimental group

Description:

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

Treatment:

Behavioral: Resilient Together-YOD

Control Patient-Caregiver Dyads

Active Comparator group

Description:

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

Treatment:

Behavioral: Health Enhancement Program-YOD