Health TrialsbyHealthPanel

Resilient Together for Dementia (RT-D)

ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Resilient Together for DementiaExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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)
2

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)
3

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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