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NCT Number: NCT07488559

Engage Coaching (R33 Phase)

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.

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Key information

Conditions

Social Connection Loneliness Social-emotional Quality of Life Suicide Ideation

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Kimberly Van Orden, PhD

CONTACT

[email protected]

(585) 273-1811

About this study

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 social connection. Subjects will complete EMA daily following 3 personally-selected times for prompts (to enhance recall and ease of completion of assessments) for 10-days prior to starting study interventions, beginning the day after the baseline visit. Each EMA instance takes approximately 2-5 minutes to complete. Subjects who successfully complete the smartphone assessment protocol at baseline will be randomly assigned to coaching or waitlist control. Study conditions are Engage Coaching (10 individual coaching sessions) over (up to) 4 month or waitlist control (assessments only for 4 months and then coaching is offered). The follow-up assessments include baseline measures and EMA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Current problem drinking
  • Psychosis
  • Significant cognitive impairment
  • Hearing problems that preclude engagement with S-ENG and research assessors.

Treatment and study plan

Social Engage Coaching (S-ENG)

Behavioral

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 connection most important to subjects; and assessment of current social networks and social activities. Together, the coach and subject create a conceptualization of reasons for loneliness and identify personalized activities most likely to impact loneliness. The primary activity is 'action planning,' which involves selecting a social goal for the week, brainstorming ways to meet the goal, identifying barriers, and selecting specific actions to take before the next session. The first 8 sessions are offered weekly and the final two are monthly booster sessions.

Primary outcomes

  1. Loneliness

    Time frame: 8-week follow-up

    PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) for 10 days.

  2. Belonging

    Time frame: 8-week follow-up

    Interpersonal Needs Questionnaire assessed by Ecological Momentary Assessment (EMA) for 10 days.

  3. Time in conversations

    Time frame: 8-week follow-up

    Self-report of frequency of conversations with others assessed by Ecological Momentary Assessment (EMA) for 10 days.

  4. Time outside the home

    Time frame: 8-week follow-up

    Self-report of frequency of time outside the home assessed by Ecological Momentary Assessment (EMA) for 10 days.

Secondary outcomes

  1. Suicide ideation

    Time frame: 16-week follow-up

    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.

  2. Depression

    Time frame: 16-week follow-up

    PROMIS Depression Short Form assessed by Ecological Momentary Assessment (EMA) for 10 days.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 23, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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