Resilient Together for Dementia (RT-D) (RT-D)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Resilient Together for Dementia; Behavioral: MEUC

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah M. Bannon, PhD; Phone Number: 212-241-0787; Email: sarah.bannon@mountsinai.org
• Study Contact Backup: Name: Sydney M, McCage; Phone Number: 212-241-6866; Email: sydney.mccage@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Brain Injury Research Center at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Resilient Together for Dementia; The research team will compare two programs to reduce emotional distress among couples after dementia diagnosis.

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.; Other Names: RT-D; 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.; Other Names: Minimally enhanced usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants screened	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. The research team will measure with the proportion of participants screened.	After each dyad completion, throughout study of 6-8 weeks
Proportion of participants who consent or not consent to participate	Feasibility of consent - by keeping a record of all individuals who complete screening that consent, refuse to consent, and the reasons for refusal will be monitored and will review progress in weekly team meetings. The research team will measure with the proportion of participants who consent or not consent to participate	After each dyad completion, throughout study of 6-8 weeks
Proportion of sessions participants attend	The number of sessions that enrolled dyads attend as well as missed sessions, treatment dropouts, and reasons for nonattendance will be monitored and will review progress in weekly meetings. The research team will measure with the proportion of sessions participants attend.	After each dyad completion, throughout study of 6-8 weeks
Credibility and Expectancy Questionnaire (CEQ)	A scale measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Full scale from 0-10, with higher score indicating higher treatment expectancy	After each dyad completion, throughout study of 6-8 weeks
Client Satisfaction Questionnaire	A 3-item questionnaire assessing participants' satisfaction with participation in the study. Full scale from 0-12, with higher score indicating greater satisfaction.	After each dyad completion, throughout study of 6-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale	A 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Full scale score is 0 to 42, with higher score indicating more emotional distress.	Baseline to posttest (6-8 weeks)
Geriatric Depression Scale	A 15-item scale with yes/no responses, total scores range from 0 to 15. Scores of 0-4 are considered normal, 5-8 indicate mild depression, 9-11 suggest moderate depression, and 12-15 indicate severe depression. Higher scores indicate more severe depressive symptoms.	Baseline to posttest (6-8 weeks)
Perceived Stress Scale	A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress.	Baseline to posttest (6-8 weeks)

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sarah Bannon, PhD, Icahn School of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Dementia; Emotional distress; Couples; Dyads; Care partners
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: GCO 23-0519-0001; 1K23AG075188 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact sarah.bannon@mountsinai.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No