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A new behavioral coaching aims to combat loneliness in dementia caregivers

NCT ID NCT05812989

Symptom relief Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study tests whether a brief coaching program called Social Engage can reduce loneliness in older adults who care for a loved one with Alzheimer's or related dementia. Participants will receive up to eight weekly one-on-one sessions by phone or video call. Researchers will also measure how the coaching affects stress responses and emotional regulation, and whether a digital tool helps coaches deliver the program consistently.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Social Engage coaching, a behavioral psychotherapy delivered via phone or video call
What this could lead to
If effective, this coaching approach could offer a practical, scalable way to reduce loneliness and improve emotional well-being in older adults caring for loved ones with dementia.
What could go wrong
The trial is small and early, so results may not apply broadly. Benefits may be modest, and the coaching requires time and engagement from participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

52 people

The number who actually took part.

Started

Oct 2023

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Caregiver (age 50 or older) for a community-dwelling loved one with Alzheimer's disease or related dementia (ADRD), living with (or in close proximity to) the person with ADRD. * Elevated caregiving distress: above population mean (\>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score \>= 5) on the Modified Caregiver Strain Index. * Social disconnection: UCLA Loneliness Scale: Short Form score of \> 5. Exclusion Criteria: * Non-English speaking * Significant cognitive impairment * Major cardiovascular conditions that may interfere with reliable assessment of HRV (e.g., congestive heart failure, pacemaker, prior myocardial infarction).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Loneliness

Contacts and locations

Locations

  • University of Rochester

    Rochester, New York, 14642, United States

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