Study 1: Social Engage Coaching R61 Phase

Not Applicable

Active, not recruiting

• Conditions: Loneliness; Social Isolation; Suicide Ideation; Quality of Life
• Interventions: Behavioral: Social Engage Coaching (S-ENG)

• Registration Number: NCT05745493
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of this study is to test whether an individual coaching program called Social Engage Coaching (or 'Engage Coaching' for short) helps adults age 60 and older feel more connected to other people in ways that matter to them. Procedures include participating in a Social Engage Coaching program, research assessments with surveys, and assessments completed on a cell phone. Engage Coaching involves individual sessions with a trained Engage Coach (up to 10 sessions) that are designed to help participants improve social relationships and well-being. All subjects will receive the scheduled baseline and follow-up interviews by the research team. These interviews will be conducted at study start, mid-way through the program at 8 weeks and after completing the program at 16 weeks. Interviews will be via Zoom/phone as well as surveys done online.

Detailed Description

The R61 phase is a single-arm trial of S-ENG plus eCAU (n=30) with 1 week of smartphone-based target assessment at baseline, 8-weeks and 16-weeks. Participants are 30 adults age 60 and older who report clinically significant loneliness and suicide ideation and reside in a senior living community (SLC). We will use ambulatory assessment via smartphones, including both active self-report (ecological momentary assessment, EMA) and passive sensing (audio recordings \& GPS) to comprehensively assess indices of social connection. Subjects will complete EMA recordings using a smartphone 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. EMA will be integrated with other smartphone technology to passively capture social behavior. The Electronically Activated Recorder (EAR) will passively measure social behavior (i.e., conversation frequency, duration, and valence). GPS- will track time outside the home. Subjects will be given a study smartphone designed for older adults to use during assessment periods. All subjects who successfully complete the smartphone assessment protocol at baseline will be assigned to S-ENG. S-ENG involves 10 individual coaching sessions over (up to) 4 months. S-ENG is a stepped, modular intervention that addresses barriers to action plan implementation and challenges in processing positive outcomes when exposed to socially rewarding activities. Psychoeducational materials address the importance of social connection. Subjects complete a values clarification exercise on aspects of connection most important to participants to inform personalized activities most likely to impact loneliness. Coaches are instructed to focus action plans on activities that foster social connection. The follow-up assessments at 8- and 16-weeks include baseline measures and smartphone measures.

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-02-27
• Study Start: 2023-06-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Social Engage Coaching (S-ENG)	Social Engage Coaching (S-ENG)	Social Engage Coaching is 10 individual sessions of coaching to increase social connection.

Primary Outcome Measures

Name	Time	Method
Time in conversations	16-week follow-up	Smartphone passive sensing of ambient audio recordings to identify amount of time in conversations with others.
Loneliness	16-week follow-up	PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) on smartphones
Satisfaction with Social Activities	16-week follow-up	PROMIS Satisfaction with Participation in Discretionary Social Activities Short Form assessed by Ecological Momentary Assessment (EMA) on smartphones
Time outside the home	16-week follow-up	Amount of time outside the home assessed via smartphone.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States