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Clinical Trial NCT07488559 for Social Connection, Loneliness, Suicide Ideation, Social-emotional Quality of Life is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Engage Coaching (R33 Phase) 120

Not yet recruiting
Clinical Trial NCT07488559 is an interventional study for Social Connection, Loneliness, Suicide Ideation, Social-emotional Quality of Life and is currently not yet recruiting. Enrollment is planned to begin on 15 May 2026 and continue until the study accrues 120 participants. Led by University of Rochester, this study is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
The purpose of this study is to test whether an individual coaching program helps adults age 60 and older feel more connected to other people in ways that matter to them.
Detailed Description
The R33 phase is an RCT (S-ENG+eCAU vs. eCAU only; n=120) with follow-up at 8- and 16 weeks to test target engagement and clinical impact. 10 days of ecological momentary assessment (EMA) will be completed at all assessment points. Participants are 120 adults age 60 and older who report clinically significant loneliness and have access to social activities outside the home. EMA will comprehensively assess indices of ...Show More
Official Title

Engage Coaching to Reduce Social Isolation and Loneliness to Prevent Suicide in Later Life

Conditions
Social ConnectionLonelinessSuicide IdeationSocial-emotional Quality of Life
Other Study IDs
NCT ID Number
NCT07488559
Start Date (Actual)
2026-05-15
Last Update Posted
2026-03-27
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Loneliness
Older adults
Ecological momentary assessment
Engage Psychotherapy
Late-life suicide
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalEngage Coaching
Engage Coaching
Social Engage Coaching (S-ENG)
Social Engage Coaching (S-ENG) involves 10 individual coaching sessions focused on increasing social connection. S-ENG is a stepped, modular intervention that was developed to allow personalization to a given subject's needs, preferences, and individualized barriers to social connection. Early sessions include psychoeducation on the importance of social connection; a values clarification exercise on aspects of connec...Show More
No InterventionWaitlist Control
Study intervention (coaching) is provided after study completion (assessments)
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Loneliness
PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) for 10 days.
8-week follow-up
Belonging
Interpersonal Needs Questionnaire assessed by Ecological Momentary Assessment (EMA) for 10 days.
8-week follow-up
Time in conversations
Self-report of frequency of conversations with others assessed by Ecological Momentary Assessment (EMA) for 10 days.
8-week follow-up
Time outside the home
Self-report of frequency of time outside the home assessed by Ecological Momentary Assessment (EMA) for 10 days.
8-week follow-up
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Suicide ideation
Geriatric Suicide Ideation Scale Screening version that provides a continuous score of severity of suicide ideation with four items, assessed by Ecological Momentary Assessment (EMA) for 10 days.
16-week follow-up
Depression
PROMIS Depression Short Form assessed by Ecological Momentary Assessment (EMA) for 10 days.
16-week follow-up
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
60 Years
Eligible Sexes
All
  • Age 60 or older
  • Access to social activities outside the home, including through living in senior living communities
  • Clinically-significant loneliness over the prior month.

  • Current problem drinking
  • Psychosis
  • Significant cognitive impairment
  • Hearing problems that preclude engagement with S-ENG and research assessors.
University of Rochester logoUniversity of Rochester195 active studies to explore
National Institute of Mental Health (NIMH) logoNational Institute of Mental Health (NIMH)
Study Responsible Party
Kimberly Van Orden, Principal Investigator, Professor, University of Rochester
No contact data.