Engage Coaching (R33 Phase)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Loneliness; Suicide Ideation; Social Connection; Social-emotional Quality of Life
• Intervention / Treatment: Behavioral: Social Engage Coaching (S-ENG)

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Engage Coaching	Behavioral: 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 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.
No Intervention: Waitlist Control; Study intervention (coaching) is provided after study completion (assessments)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Loneliness; Older adults; Ecological momentary assessment; Engage Psychotherapy; Late-life suicide
• Other Study ID Numbers: STUDY00408657; R33MH129476-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared via the NIMH Data Archive in line with NIMH policies.
• IPD Sharing Access Criteria: Data will be accessible via the NIMH Data Archive.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No