search
Back to results

Study 1: Social Engage Coaching R61 Phase (R61 Phase)

Primary Purpose

Social Isolation, Loneliness, Suicide Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Engage Coaching (S-ENG)
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Isolation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Social Engage Coaching (S-ENG)

Arm Description

Social Engage Coaching is 10 individual sessions of coaching to increase social connection.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 16, 2023
Last Updated
June 6, 2023
Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT05745493
Brief Title
Study 1: Social Engage Coaching R61 Phase
Acronym
R61 Phase
Official Title
Promoting Social Connection to Prevent Late-Life Suicide
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Isolation, Loneliness, Suicide Ideation, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Engage Coaching (S-ENG)
Arm Type
Experimental
Arm Description
Social Engage Coaching is 10 individual sessions of coaching to increase social connection.
Intervention Type
Behavioral
Intervention Name(s)
Social Engage Coaching (S-ENG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Loneliness
Description
PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) on smartphones
Time Frame
16-week follow-up
Title
Satisfaction with Social Activities
Description
PROMIS Satisfaction with Participation in Discretionary Social Activities Short Form assessed by Ecological Momentary Assessment (EMA) on smartphones
Time Frame
16-week follow-up
Title
Time in conversations
Description
Smartphone passive sensing of ambient audio recordings to identify amount of time in conversations with others.
Time Frame
16-week follow-up
Title
Time outside the home
Description
Amount of time outside the home assessed via smartphone.
Time Frame
16-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Van Orden, PhD
Phone
585-275-5176
Email
kimberly_vanorden@urmc.rochester.edu
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Van Orden, PhD
Phone
585-275-5176
Email
kimberly_vanorden@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Kimberly A Van Orden, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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).
IPD Sharing URL
https://nda.nih.gov

Learn more about this trial

Study 1: Social Engage Coaching R61 Phase

We'll reach out to this number within 24 hrs