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Emotional Support Programs for Loneliness

N/A
Recruiting
Led By Kathi L Heffner, PhD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 weeks
Awards & highlights

Study Summary

This trial aims to study how emotion regulation can help lonely caregivers and the benefit of digital tools for coaches to improve outcomes. It is funded by the National Institute on Aging.

Who is the study for?
This trial is for caregivers aged 50 or older who look after a loved one with Alzheimer's or related diseases at home. They must feel stressed above average levels, have moderate caregiver strain, and experience loneliness. Those with major heart conditions, non-English speakers, or significant cognitive issues cannot join.Check my eligibility
What is being tested?
The study tests two interventions: 'Connect for Caregivers', a behavioral coaching program aimed at reducing loneliness; and 'Social Engage Coaching', which uses digital tools to help coaches improve their support to caregivers.See study design
What are the potential side effects?
Since the interventions are non-medical (behavioral coaching and digital tools), typical medical side effects are not expected. Participants may experience emotional discomfort discussing personal feelings during sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Affect (valence) from Self-Assessment Manikin
Dot probe task
High frequency heart rate variability (HF-HRV)
+2 more
Secondary outcome measures
Flanker Task
Set-Shifting Task

Trial Design

2Treatment groups
Active Control
Group I: Social Engage CoachingActive Control1 Intervention
Social Engage Coaching involves psychoeducation on the importance of social connections for health as well as structured goal setting and problem solving for increasing social connectedness.
Group II: Social Engage Coaching with Connect for CaregiversActive Control2 Interventions
Social Engage Coaching involves psychoeducation on the importance of social connections for health as well as structured goal setting and problem solving, guided by use of a digitized prioritization tool, for increasing social connectedness.

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Who is running the clinical trial?

University of RochesterLead Sponsor
840 Previous Clinical Trials
534,193 Total Patients Enrolled
9 Trials studying Loneliness
611 Patients Enrolled for Loneliness
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,828 Total Patients Enrolled
13 Trials studying Loneliness
3,089 Patients Enrolled for Loneliness
Kathi L Heffner, PhDPrincipal InvestigatorUniversity of Rochester
2 Previous Clinical Trials
347 Total Patients Enrolled

Media Library

Connect for Caregivers Clinical Trial Eligibility Overview. Trial Name: NCT05812989 — N/A
Loneliness Research Study Groups: Social Engage Coaching, Social Engage Coaching with Connect for Caregivers
Loneliness Clinical Trial 2023: Connect for Caregivers Highlights & Side Effects. Trial Name: NCT05812989 — N/A
Connect for Caregivers 2023 Treatment Timeline for Medical Study. Trial Name: NCT05812989 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation have any remaining openings for participants?

"According to the clinicaltrials.gov website, this study is no longer recruiting candidates as it was last updated on March 31st 2023. Nevertheless, there are 48 other trials actively seeking volunteers at this moment in time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Modifiers and Mechanisms of Loneliness Interventions
Kathi Heffner 2023. "Modifiers and Mechanisms of Loneliness Interventions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05812989.
~38 spots leftby May 2025
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