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

Not Applicable

Not yet recruiting

• Conditions: Young Onset Dementia

• Registration Number: NCT07018726
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Study Start: 2026-01-01
• Primary Completion: 2030-07-01
• Study Completion: 2031-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 388

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 [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

• And 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Emotional Distress	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 Outcome Measures

Name	Time	Method
Change in Self-Efficacy	0 weeks, 6 weeks, 12 weeks	The General Self-Efficacy Scale-short form (GSE-6); 6-24, higher scores indicate greater self-efficacy
Change in Resiliency Factors (Mindfulness)	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)	0 week, 6 weeks, 12 weeks	Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope
Changes in Relationship Quality	0 weeks, 6 weeks, 12 weeks	Dyadic Relationship Scale (DRS); 0-33, higher scores indicate greater relationship quality

Trial Locations

Locations (1)

Massachusetts General Hospital (MGH); 🇺🇸 Boston, Massachusetts, United States