Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-02-19
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Resilient Together for Dementia
The research team will compare two programs to reduce emotional distress among couples after dementia diagnosis.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Sarah Bannon
Assistant Professor
Principal Investigators
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Sarah Bannon, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Brain Injury Research Center at Mount Sinai
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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GCO 23-0519-0001
Identifier Type: -
Identifier Source: org_study_id
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