Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05745493
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-02-16
Brief Title:
Study 1 Social Engage Coaching R61 Phase
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Promoting Social Connection to Prevent Late-Life Suicide
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R61 Phase
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 Zoomphone as well as surveys done online
Detailed Description:
The R61 phase is a single-arm trial of S-ENG plus eCAU n30 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R61MH129476 | NIH | None | httpsreporternihgovquickSearchR61MH129476 |