Resilient Together for Dementia (RT-D)

NCT06619327 | Recruiting

• 2 other identifiers: GCO 23-0519-00011K23AG075188
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Hospital Anxiety and Depression Scale

  Baseline to posttest (6-8 weeks)

• Geriatric Depression Scale

  Baseline to posttest (6-8 weeks)

• Perceived Stress Scale

  Baseline to posttest (6-8 weeks)

Study Arms (1)

Resilient Together for Dementia

EXPERIMENTAL

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

Behavioral: Resilient Together for Dementia; Behavioral: MEUC

Interventions

Resilient Together for Dementia BEHAVIORAL

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

Resilient Together for Dementia

MEUC BEHAVIORAL

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

Resilient Together for Dementia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

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

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

Study Sites (1)

Brain Injury Research Center at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sarah Bannon, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah M. Bannon, PhD

CONTACT

212-241-0787; sarah.bannon@mountsinai.org

Sydney M, McCage

CONTACT

212-241-6866; sydney.mccage@mountsinai.org

Study Design

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

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: February 19, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)