Engage Coaching (R33 Phase)

NCT07488559 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00408657R33MH129476-03
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Social-emotional Quality of Life; Social Connection; Loneliness; Suicide Ideation

Keywords

Loneliness; Older adults; Ecological momentary assessment; Engage Psychotherapy; Late-life suicide

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Suicide ideation

  16-week follow-up

• Depression

  16-week follow-up

Study Arms (2)

Engage Coaching

EXPERIMENTAL

Engage Coaching

Behavioral: Social Engage Coaching (S-ENG)

Waitlist Control

NO INTERVENTION

Study intervention (coaching) is provided after study completion (assessments)

Interventions

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.

Engage Coaching

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Data will be accessible via the NIMH Data Archive.