Study 1: Social Engage Coaching R61 Phase

Quality of Life Clinical Trial

— R61 Phase  

Official title:

Promoting Social Connection to Prevent Late-Life Suicide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05745493
• Other study ID #: 408656
• Secondary ID: R61MH129476
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: Kim Van Orden, PhD
• Phone: 585-275-5176
• Email: kimberly_vanorden[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion criteria are adults age 60 or older who live in senior living communities, endorse clinically-significant loneliness and suicide ideation over the prior month. Exclusion criteria are current problem drinking, psychosis, significant cognitive impairment, and hearing problems that preclude engagement with S-ENG and research assessors.

Related Conditions & MeSH terms

• Loneliness
• Quality of Life
• Social Isolation
• Suicide
• Suicide Ideation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

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