Young Onset DementiaNCT07018726
Addressing Emotional Distress in Dyads of Persons With a Young Onset Dementia (YOD) and Their Care-partners
A study testing Resilient Together-YOD and Health Enhancement Program-YOD in people with Young Onset Dementia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Young Onset Dementia
- What is being tested?
- Resilient Together-YOD and Health Enhancement Program-YOD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to 1 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Criteria:
- 40 years of age or older
- Diagnosis of young-onset dementia (FTD, PPA, AD, PCA, etc.) with symptom onset prior to age 65 or evidence of familial AD onset up to age 70
- Received YOD diagnosis in the past 10 months
- English fluency and literacy
- Cognitive ability to understand study and research protocol in order to consent to participation in intervention per referring neurologist and/or consent teach back questions
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- Must have a care-partner willing to participate
- Care-Partner Criteria:
- 18 years of age or older
- Care-partner to person diagnosed with young-onset dementia (FTD, PPA, AD, PCA, etc.)
- English fluency and literacy
- Dyad Criteria: (Both Patient and Care-Partner):
- -At least one dyad member reports elevated emotional distress (HADS>7)
Who cannot join
- An additional, terminal diagnosis such as cancer
- Unwillingness to participate and use zoom for video conferencing
- Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maggie L Syme, PhD, MPH contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Ana-Maria Vranceanu, PhD, 617-724-4977, avranceanu@mgh.harvard.edu
Ana-Maria Vranceanu, PhD
About this study
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
- Being tested
- Resilient Together-YOD, Health Enhancement Program-YOD
- Keywords
- Emotional Distress, Dyadic Intervention, Young Onset Dementia, Caregiving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilient Together-YODBehavioural
Also called Skills-based intervention
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-YODBehavioural
Also called Educational program
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental Patient-Caregiver Dyads | Experimental | There will be 6 sessions delivered via live video using Zoom. Content will be primarily skills. Receives: 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. Receives: Behavioral: Health Enhancement Program-YOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 weeks, 6 weeks, 12 weeks
Secondary outcomes (6)
Change in Resiliency Factors (Mindfulness)
Cognitive and Affective Mindfulness Scale (CAMS); 12-48, higher scores indicate greater perceived mindfulness
Measured: 0 weeks, 6 weeks, 12 weeks
Change in Resiliency Factors (Individual Coping)
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
Measured: 0 week, 6 weeks, 12 weeks
Change in Resiliency Factors (Mindfulness Utilization)
Applied Mindfulness Scale (AMPS); 0-60, higher scores indicate greater use of mindfulness practices.
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in Interpersonal Factors (Dyad Coping)
Dyadic Coping Inventory (DCI); 37-185, higher scores indicate greater perceived coping in the context of a relationship
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in Resiliency Factors (Perceived Social Support)
Multidimensional Scale of Perceived Social Support (MSPSS); 12-84, higher scores indicate greater perceived social support from family, friends, and significant others
Measured: 0 weeks, 6 weeks, 12 weeks
Changes in Resiliency Factors (Values-based Living)
Valuing Questionnaire (VQ); Progress and Obstruction Subscale Scores: 0-30, higher scores indicate living in greater accordance with one's values
Measured: 0 weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start28 Jan 2026
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young Onset DementiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018726
- Sponsor's protocol ID
- 2025P001534
- Status last verified
- Apr 2026
- First submitted
- 4 Jun 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Emotional Distress in Dyads of Persons With a Young Onset Dementia (YOD) and Their Care-partners
- ClinicalTrials.gov ID
- NCT07018726
- Acronym / sponsor ID
- 2025P001534
- Conditions
- Young Onset Dementia
- Keywords
- Emotional Distress, Dyadic Intervention, Young Onset Dementia, Caregiving
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental Patient-Caregiver Dyads | Experimental | Behavioral: Resilient Together-YODThere will be 6 sessions delivered via live video using Zoom. Content will be primarily skills. |
| Control Patient-Caregiver Dyads | Active comparator | Behavioral: Health Enhancement Program-YODThere will be 6 sessions delivered via live video using Zoom. Content will be primarily educational. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 40 years of age or older
- Diagnosis of young-onset dementia (FTD, PPA, AD, PCA, etc.) with symptom onset prior to age 65 or evidence of familial AD onset up to age 70
- Received YOD diagnosis in the past 10 months
- English fluency and literacy
- Cognitive ability to understand study and research protocol in order to consent to participation in intervention per referring neurologist and/or consent teach back questions
Key exclusion criteria (3 listed)
- An additional, terminal diagnosis such as cancer
- Unwillingness to participate and use zoom for video conferencing
- Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilient Together-YODAlso: Skills-based interventionThis 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. | Behavioural | Experimental: Experimental Patient-Caregiver Dyads |
| Health Enhancement Program-YODAlso: Educational programThis 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. | Behavioural | Control Patient-Caregiver Dyads |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Young Onset Dementia
RecruitingObservational study
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Not yet recruitingObservational study
YOD-RiSoCo: Social Cognition and Risk-taking Behaviour in Patients with Young-onset Dementia
Young-onset Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maggie L Syme, PhD, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilient Together-YOD and Health Enhancement Program-YOD in people with Young Onset Dementia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana-Maria Vranceanu, PhD (617-724-4977, avranceanu@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotional Distress (time frame: 0 weeks, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.