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Recruiting NCT07018726

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

No phase Interventional Young Onset Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resilient Together-YOD, Health Enhancement Program-YOD.
Who it may be relevant to
Registry conditions: Young Onset Dementia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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,
  • 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.

Primary outcome measures

  • Change in Emotional Distress [Time frame: 0 weeks, 6 weeks, 12 weeks]
Secondary outcome measures (6)
  • Change in Resiliency Factors (Mindfulness) [Time frame: 0 weeks, 6 weeks, 12 weeks]
  • Change in Resiliency Factors (Individual Coping) [Time frame: 0 week, 6 weeks, 12 weeks]
  • Change in Resiliency Factors (Mindfulness Utilization) [Time frame: 0 weeks, 6 weeks, 12 weeks]
  • Changes in Interpersonal Factors (Dyad Coping) [Time frame: 0 weeks, 6 weeks, 12 weeks]
  • Changes in Resiliency Factors (Perceived Social Support) [Time frame: 0 weeks, 6 weeks, 12 weeks]
  • Changes in Resiliency Factors (Values-based Living) [Time frame: 0 weeks, 6 weeks, 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts General Hospital (MGH) — Boston

Identifiers

NCT: NCT07018726 · 2025P001534

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗