Recruiting

RT-D

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06619327

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Resilient Together for Dementia

MEUC

Study Details

Brief 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.

Conditions

Dementia

Study ID

NCT06619327

Start date

Feb 19, 2025

Status verified date

Jun, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Resilient Together for Dementia

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

Interventions

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.

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.

Primary outcome measure

  • 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 [ Time Frame: After each dyad completion, throughout study of 6-8 weeks ]
  • Proportion of sessions participants attend [ Time Frame: After each dyad completion, throughout study of 6-8 weeks ]
  • Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: After each dyad completion, throughout study of 6-8 weeks ]
  • Client Satisfaction Questionnaire [ Time Frame: After each dyad completion, throughout study of 6-8 weeks ]

Central Contacts and Locations

Locations

Brain Injury Research Center at Mount Sinai

Recruiting

New York, New York, United States, 10029

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Dementia
  • Care partners
  • Dyads
  • Emotional distress
  • Quality of life
  • Couples

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-04.