Social IsolationR61 PhaseNCT05745493
Study 1: Social Engage Coaching R61 Phase
A study testing Social Engage Coaching (S-ENG) in people with Social Isolation and Loneliness, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Social Isolation, Loneliness, Suicide Ideation
- What is being tested?
- Social Engage Coaching (S-ENG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Social Connection to Prevent Late-Life Suicide
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.
Read the 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.
- Conditions
- Social Isolation, Loneliness, Suicide Ideation, Quality of Life
- Being tested
- Social Engage Coaching (S-ENG)
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Engage Coaching (S-ENG)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Engage Coaching (S-ENG) | Experimental | Social Engage Coaching is 10 individual sessions of coaching to increase social connection. Receives: Behavioral: Social Engage Coaching (S-ENG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) on smartphones
Measured: 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
Measured: 16-week follow-up
Time in conversations
Smartphone passive sensing of ambient audio recordings to identify amount of time in conversations with others.
Measured: 16-week follow-up
Time outside the home
Amount of time outside the home assessed via smartphone.
Measured: 16-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start13 Jun 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kimberly Van Orden, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745493
- Sponsor's protocol ID
- 408656
- Other IDs
- R61MH129476
- Acronym
- R61 Phase
- Status last verified
- Dec 2025
- First submitted
- 16 Feb 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Social Connection to Prevent Late-Life Suicide
- ClinicalTrials.gov ID
- NCT05745493
- Acronym / sponsor ID
- R61 Phase / 408656
- Conditions
- Social Isolation, Loneliness, Suicide Ideation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social Engage Coaching (S-ENG) | Experimental | Behavioral: Social Engage Coaching (S-ENG)Social Engage Coaching is 10 individual sessions of coaching to increase social connection. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Social Engage Coaching (S-ENG) |
Primary outcome
Loneliness
Time frame: 16-week follow-up
PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) on smartphones
Satisfaction with Social Activities
Time frame: 16-week follow-up
PROMIS Satisfaction with Participation in Discretionary Social Activities Short Form assessed by Ecological Momentary Assessment (EMA) on smartphones
Time in conversations
Time frame: 16-week follow-up
Smartphone passive sensing of ambient audio recordings to identify amount of time in conversations with others.
Time outside the home
Time frame: 16-week follow-up
Amount of time outside the home assessed via smartphone.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Engage Coaching (S-ENG) in people with Social Isolation and Loneliness, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: 16-week follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.