An interventional study of Resilient Together for Dementia and MEUC in Dementia, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 24 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Additional inclusion criteria for dyads are:
Exclusion Criteria:
The research team will compare two programs to reduce emotional distress among couples after dementia diagnosis.
Behavioral: Resilient Together for Dementia · Behavioral: MEUC
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.
Also known as: RT-D
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.
Also known as: Minimally enhanced usual care
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: After each dyad completion, throughout study of 6-8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to posttest (6-8 weeks)
Plan to share: No — 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
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Icahn School of Medicine at Mount Sinai