Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Location contact
Ana-Maria Vranceanu, PhD
CONTACT
Ana-Maria Vranceanu, PhD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07018726
Addressing Emotional Distress in Dyads of Persons With a Young Onset Dementia (YOD) and Their Care-partners
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Resilient Together-YOD
BehavioralThis 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.
Other names: Skills-based intervention
Health Enhancement Program-YOD
BehavioralThis 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.
Other names: Educational program
Primary outcomes
-
Change in Emotional Distress
Time frame: 0 weeks, 6 weeks, 12 weeks
Hospital Depression and Anxiety Scale total score (HADS); 0-21 for each subscale (anxiety and depression), higher scores indicate greater anxiety or depression
Secondary outcomes
-
Change in Resiliency Factors (Mindfulness)
Time frame: 0 weeks, 6 weeks, 12 weeks
Cognitive and Affective Mindfulness Scale (CAMS); 12-48, higher scores indicate greater perceived mindfulness
-
Change in Resiliency Factors (Individual Coping)
Time frame: 0 week, 6 weeks, 12 weeks
Measure of Current Status Part A (MOCS-A) Assertiveness and Coping Confidence subscales; Subscale scores: 0-4; higher scores indicate greater perceived ability to cope
-
Change in Resiliency Factors (Mindfulness Utilization)
Time frame: 0 weeks, 6 weeks, 12 weeks
Applied Mindfulness Scale (AMPS); 0-60, higher scores indicate greater use of mindfulness practices.
-
Changes in Interpersonal Factors (Dyad Coping)
Time frame: 0 weeks, 6 weeks, 12 weeks
Dyadic Coping Inventory (DCI); 37-185, higher scores indicate greater perceived coping in the context of a relationship
-
Changes in Resiliency Factors (Perceived Social Support)
Time frame: 0 weeks, 6 weeks, 12 weeks
Multidimensional Scale of Perceived Social Support (MSPSS); 12-84, higher scores indicate greater perceived social support from family, friends, and significant others
-
Changes in Resiliency Factors (Values-based Living)
Time frame: 0 weeks, 6 weeks, 12 weeks
Valuing Questionnaire (VQ); Progress and Obstruction Subscale Scores: 0-30, higher scores indicate living in greater accordance with one's values
Other outcomes
-
Global Impressions of Change
Time frame: 6 weeks, 12 weeks
Modified Global Impressions of Chance (MGIC); 1-7, higher scores indicate greater perceived change in outcomes
-
Cognition
Time frame: 0 weeks
Montreal Cognitive Assessment (MoCA); 0-30, lower scores indicate greater cognitive dysfunction
Study contacts
Contact information is provided by the study sponsor or research team.
Ana-Maria Vranceanu, PhD
CONTACT
Maggie L Syme, PhD, MPH
CONTACT
Sponsors and collaborators
Lead sponsor
Massachusetts General Hospital
Other
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2030
- Study completion
- 2031
- First posted
- Jun 12, 2025
- Registry last updated
- Apr 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.