Resilient Together for Dementia

NCT06421545 | Completed

• 2 other identifiers: GCO 23-05191K23AG075188-01A1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD).

Conditions

Alzheimer's Disease and Related Dementias

Outcome Measures

Primary Outcomes (1)

• Proportion of potential eligible participants

  Feasibility of recruitment - Recruitment will be monitored by screening clinic visits for potentially eligible individuals and review recruitment progress in weekly meetings to promote completion within the study time frame. Recruitment will be monitored but will not set official benchmarks and modify procedures after each dyad.

  After each dyad completion, throughout study of 1.5-2 months

Secondary Outcomes (4)

• Proportion of participants screened

  After each dyad completion, throughout study of 1.5-2 months

• Proportion of participants who consent or not consent to participate

  After each dyad completion, throughout study of 1.5-2 months

• Proportion of sessions participants attend

  After each dyad completion, throughout study of 1.5-2 months

• Change in Hospital Anxiety and Depression Scale (HADS)

  Baseline and 6 weeks (post-intervention)

Study Arms (1)

Open Pilot RT-D Dyads

EXPERIMENTAL

Persons living with dementia (PWDs) and their spousal care-partners

Behavioral: Resilient Together for Dementia

Interventions

Resilient Together for Dementia BEHAVIORAL

A novel live video dyadic resiliency intervention

Also known as: RT-D

Open Pilot RT-D Dyads

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Recent (\~1 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 his/her problems (as determined by the treating neurologist), and
• ability to understand study and research protocol, as determined by a standardized teach-back method assessment84.
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Brain Injury Research Center at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• McCage S, Walker K, Cornelius T, Parker RA, Dams-O'Connor K, Dickerson B, Ritchie C, Vranceanu AM, Bannon S. A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-Partners Early After Diagnosis: Protocol for Open Pilot of Resilient Together for Dementia. JMIR Res Protoc. 2025 Jan 15;14:e60382. doi: 10.2196/60382.

  PMID: 39814366 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sarah Bannon

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 20, 2024
• Study Start: April 19, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link tbd).

Locations

US (1)