Resilient Together for Dementia (RT-D)

Last updated: March 5, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Treatment

Resilient Together for Dementia

MEUC

Clinical Study ID

NCT06619327
GCO 23-0519-0001
1K23AG075188
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, asdetermined 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 astandardized 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 duringscreening (>7 on Hospital Anxiety and Depression scale subscales or <5 on theGeriatric Depression Scale)

Exclusion

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 wouldpreclude participation (e.g., Frontotemporal Dementia- behavioral variant), asdetermined by treatment team.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Resilient Together for Dementia
Phase:
Study Start date:
February 19, 2025
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Brain Injury Research Center at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

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