Resilient Together for Dementia (RT-D)

Mount Sinai Health System

Status: Enrolling

Conditions: Dementia

Treatments: Behavioral: MEUC; Behavioral: Resilient Together for Dementia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06619327

1K23AG075188 (U.S. NIH Grant/Contract)

GCO 23-0519-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recent (~3 month) chart documented ADRD diagnosis,
• ADRD symptom onset after age 65
• Cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0
• Cognitive awareness of their problems (as determined by the treating neurologist), and ability to understand study and research protocol, as determined by a standardized teach-back method assessment

Additional inclusion criteria for dyads are:

• English speaking adults (18 years or older)
• Dyad lives together
• At least one partner endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression scale subscales or <5 on the Geriatric Depression Scale)

Exclusion criteria

• Patient is deemed inappropriate by the neurology team
• Either partner has a co-occurring terminal illness
• Patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Resilient Together for Dementia

Experimental group

Description:

The research team will compare two programs to reduce emotional distress among couples after dementia diagnosis.

Treatment:

Behavioral: Resilient Together for Dementia

Behavioral: MEUC