Study 1: Social Engage Coaching R61 Phase
R61 Phase
Promoting Social Connection to Prevent Late-Life Suicide
2 other identifiers
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
February 27, 2023
CompletedStudy Start
First participant enrolled
June 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedDecember 19, 2025
December 1, 2025
2.3 years
February 16, 2023
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Loneliness
PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) on smartphones
16-week follow-up
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
Time in conversations
Smartphone passive sensing of ambient audio recordings to identify amount of time in conversations with others.
16-week follow-up
Time outside the home
Amount of time outside the home assessed via smartphone.
16-week follow-up
Study Arms (1)
Social Engage Coaching (S-ENG)
EXPERIMENTALSocial Engage Coaching is 10 individual sessions of coaching to increase social connection.
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 16, 2023
First Posted
February 27, 2023
Study Start
June 13, 2023
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Subject-level data (individual and derived variables) will be submitted annually using standard NDA data submission deadlines of July 15th each year. Subject-level data will be submitted in the data submission cycle following data collection (for individual variables) or data generation (for derived variables). The first data submission date will be the second cycle after the grant is awarded.
- Access Criteria
- Access to data for research purposes will be provided through an NDA Data Access Committee (DAC). Investigators and institutions seeking data from NDA will be expected to meet data security measures and will be asked to submit a Data Use Certification, which is cosigned by the investigator and the designated Institutional Official(s) at the NIH-recognized sponsoring institution with a current Federal Wide Assurance (FWA).
This study will use the NIMH Data Archive (NDA) system and procedures for its Data Sharing Plan. The NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation. Investigators will deposit all raw and analyzed data from experiments involving human subjects into this infrastructure. All data will be de-identified and will be collected from subjects who have broadly consented to share their data for research use or who have consented to share their data for research, with data use limitations.