NCT06619327

Resilient Together for Dementia (RT-D)

Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the feasibility and preliminary efficacy of the novel Resilient Together for Dementia (RT-D) intervention for couples following dementia diagnoses. The primary target is emotional distress, and the program aims to prevent chronic distress in at-risk couples.

Detailed description

Both persons living with dementia and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones. A pilot feasibility randomized control trial (RCT; Aim 3; NIA Stage 1B; N=50 dyads) will be conducted of the refined RT-D versus a minimally enhanced educational control (MEUC, educational pamphlet). Primary outcomes will be feasibility, credibility, and acceptability markers to inform a hybrid efficacy effectiveness R01 (year 4) of RT-D vs. MEUC (NIA Stage II). In this subsequent R01, the researcher will examine RT-D's impact on emotional distress and quality of life outcomes and test mechanisms of change (individual and interpersonal resiliency skills) through mediation and moderation. The researcher will revise the approach if feasibility benchmarks are not met.

Conditions

• Dementia

Interventions

Type	Name	Description
BEHAVIORAL	Resilient Together for Dementia	RT-D has been developed based on feedback from couples and dementia clinicians as well as prior successful dyadic interventions. RT-D was developed based on the Recovering Together (RT) dyadic intervention for acute neurological illnesses and is being adapted to address the needs of couples navigating new dementia diagnoses.
BEHAVIORAL	MEUC	The MEUC condition was also developed based on the comparison trial in the Recovering Together dyadic intervention, and was adapted based on feedback from prior studies. The program is self-guided and provides educational information similar to the RT-D condition, but with no skills practice or weekly sessions with a therapist.

Timeline

• Start date: 2025-02-19
• Primary completion: 2026-08-30
• Completion: 2027-06-30
• First posted: 2024-10-01
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States